130 results on '"Leigh Charvet"'
Search Results
2. Editorial: Neurotechnology for sensing the brain out of the lab: methods and applications for mobile functional neuroimaging
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Hasan Ayaz, Frederic Dehais, Giuseppina Pilloni, Leigh Charvet, and Marom Bikson
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electroencephalography (EEG) ,functional near-infrared spectroscopy (fNIRS) ,transcranial direct-current stimulation (tDCS) ,neuroergonomics ,neurotechnology ,neuromodulation ,Neurology. Diseases of the nervous system ,RC346-429 - Published
- 2024
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3. Simultaneous and cumulative effects of tDCS on cerebral metabolic rate of oxygen in multiple sclerosis
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Marco Muccio, Giuseppina Pilloni, Lillian Walton Masters, Peidong He, Lauren Krupp, Abhishek Datta, Marom Bikson, Leigh Charvet, and Yulin Ge
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transcranial direct current stimulation ,multiple sclerosis ,MRI ,neuronal metabolism ,cerebrovascular changes ,tDCS-aCT paired treatment ,Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Abstract
IntroductionTranscranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique with simultaneous (during stimulation) and cumulative effects (after repeated sessions) on blood flow and neuronal metabolism. These effects remain mostly unclear especially in multiple sclerosis (MS). This work aims to elucidate brain metabolic and hemodynamic underpinnings of tDCS and its potential therapeutic impact in MS patients using quantitative tDCS-MRI.MethodsMS participants (n = 20; age = 45.4 ± 12.3 years, 7 males) underwent 3 T MRI scans before and after 20 daily sessions of dorsolateral prefrontal cortex (DLFPC) tDCS (2.0 mA, left anodal) paired with adaptive cognitive training (aCT). During both visits, imaging measurements of cerebral blood flow (CBF), cerebral venous blood oxygenation (Yv) and calculated cerebral metabolic rate of oxygen (CMRO2) were obtained at pre-tDCS, during-tDCS and post-tDCS.ResultsAt baseline, significant increase from pre- to during-tDCS was observed in CMRO2 (7.6%; p = 0.002), CBF (11.0%; p
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- 2024
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4. Non-invasive brain stimulation for fatigue in post-acute sequelae of SARS-CoV-2 (PASC)
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Kelly Santana, Eduardo França, João Sato, Ana Silva, Maria Queiroz, Julia de Farias, Danniely Rodrigues, Iara Souza, Vanessa Ribeiro, Egas Caparelli-Dáquer, Antonio L. Teixeira, Leigh Charvet, Abhishek Datta, Marom Bikson, and Suellen Andrade
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Post-acute sequelae of Sars-COV-2 ,Fatigue ,Anxiety ,Non-invasive brain stimulation ,High-Definition transcranial direct current stimulation ,Respiratory rehabilitation ,Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Abstract
Background: and purpose: Fatigue is among the most common persistent symptoms following post-acute sequelae of Sars-COV-2 infection (PASC). The current study investigated the potential therapeutic effects of High-Definition transcranial Direct Current Stimulation (HD-tDCS) associated with rehabilitation program for the management of PASC-related fatigue. Methods: Seventy patients with PASC-related fatigue were randomized to receive 3 mA or sham HD-tDCS targeting the left primary motor cortex (M1) for 30 min paired with a rehabilitation program. Each patient underwent 10 sessions (2 sessions/week) over five weeks. Fatigue was measured as the primary outcome before and after the intervention using the Modified Fatigue Impact Scale (MFIS). Pain level, anxiety severity and quality of life were secondary outcomes assessed, respectively, through the McGill Questionnaire, Hamilton Anxiety Rating Scale (HAM-A) and WHOQOL. Results: Active HD-tDCS resulted in significantly greater reduction in fatigue compared to sham HD-tDCS (mean group MFIS reduction of 22.11 points vs 10.34 points). Distinct effects of HD-tDCS were observed in fatigue domains with greater effect on cognitive (mean group difference 8.29 points; effect size 1.1; 95% CI 3.56–13.01; P
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- 2023
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5. Home-administered transcranial direct current stimulation is a feasible intervention for depression: an observational cohort study
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Leigh Charvet, Allan George, Erik Charlson, Matthew Lustberg, Amy Vogel-Eyny, Tehila Eilam-Stock, Hyein Cho, Pamela Best, Luis Fernandez, Abhishek Datta, Marom Bikson, Kamran Nazim, and Giuseppina Pilloni
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depression ,non-invasive brain stimulation ,telehealth ,home-based tDCS ,digital health ,transcranial direct current stimulation (tDCS) ,Psychiatry ,RC435-571 - Abstract
Transcranial direct current stimulation (tDCS) is an emerging treatment for major depression. We recruited participants with moderate-to-severe major depressive episodes for an observational clinical trial using Soterix Medical's tDCS telehealth platform as a standard of care. The acute intervention consisted of 28 sessions (5 sessions/week, 6 weeks) of the left anodal dorsolateral prefrontal cortex (DLPFC) tDCS (2.0 mA × 30 min) followed by a tapering phase of weekly sessions for 4 weeks (weeks 7–10). The n = 16 completing participants had a significant reduction in depressive symptoms by week 2 of treatment [Montgomery–Åsberg Depression Rating Scale (MADRS), Baseline: 28.00 ± 4.35 vs. Week 2: 17.12 ± 5.32, p < 0.001] with continual improvement across each biweekly timepoint. Acute intervention responder and remission rates were 75 and 63% and 88 and 81% following the taper period (week 10).
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- 2023
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6. Remotely supervised at-home tDCS for veterans with persistent post-traumatic headache: a double-blind, sham-controlled randomized pilot clinical trial
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Leigh Charvet, Adam T. Harrison, Kiersten Mangold, Robert Davis Moore, Siyuan Guo, Jiajia Zhang, Abhishek Datta, and X. Michelle Androulakis
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veterans ,tDCS ,mTBI ,post-traumatic headache ,brain injury ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
BackgroundCurrently, there are no FDA approved therapies for persistent post-traumatic headache (PPTH) secondary to traumatic brain injury (TBI). As such neither headache nor TBI specialists have an effective means to manage PPTH. Thus, the objective of the present pilot trial was to evaluate the feasibility and preliminary efficacy of a four-week at-home remotely supervised transcranial direct current stimulation (RS-tDCS) intervention for veterans with PPTH.MethodsTwenty-five (m = 46.6 ± 8.7 years) veterans with PPTH were randomized into two groups and received either active (n = 12) or sham (n = 13) RS-tDCS, with anodal stimulation over left dlPFC and cathodal over occipital pole. Following a four-week baseline, participants completed 20–sessions of active or sham RS-tDCS with real-time video monitoring over a period of four-weeks. Participants were assessed again at the end of the intervention and at four-weeks post-intervention. Primary outcomes were overall adherence rate (feasibility) and change in moderate-to-severe headache days per month (efficacy). Secondary outcomes were changes in total number of headache days, and PPTH-related functional outcomes.ResultsAdherence rate was high with 88% of participants (active = 10/12; sham = 12/13) fully completing tDCS interventions. Importantly, there was no significant difference in adherence between active and sham groups (p = 0.59). Moderate-to-severe headache days were significantly reduced within the active RS-tDCS group (p = 0.004), compared to sham during treatment (−2.5 ± 3.5 vs. 2.3 ± 3.4), and 4-week follow-up (−3.9 ± 6.4 vs. 1.2 ± 6.5). Total number of headache days was significantly reduced within the active RS-tDCS (p = 0.03), compared to sham during-treatment (−4.0 ± 5.2 vs. 1.5 ± 3.8), and 4-week follow-up (−2.1 ± 7.2 vs. −0.2 ± 4.4).ConclusionThe current results indicate our RS-tDCS paradigm provides a safe and effective means for reducing the severity and number of headache days in veterans with PPTH. High treatment adherence rate and the remote nature of our paradigm indicate RS-tDCS may be a feasible means to reduce PPTH, especially for veterans with limited access to medical facilities.Clinical Trial Registration: ClinicalTrials.gov, identifier [NCT04012853].
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- 2023
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7. Combination of transcranial direct current stimulation with online cognitive training improves symptoms of Post-acute Sequelae of COVID-19: A case series
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Beatriz A. Cavendish, Alisson Lima, Laiss Bertola, Leigh Charvet, Marom Bikson, Andre R. Brunoni, and Kallene S. Vidal
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Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Published
- 2022
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8. Tolerability and feasibility of at-home remotely supervised transcranial direct current stimulation (RS-tDCS): Single-center evidence from 6,779 sessions
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Giuseppina Pilloni, Amy Vogel-Eyny, Matthew Lustberg, Pamela Best, Martin Malik, Lillian Walton-Masters, Allan George, Ibraheem Mirza, Lana Zhovtis, Abhishek Datta, Marom Bikson, Lauren Krupp, and Leigh Charvet
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Transcranial direct current stimulation ,tDCS ,At-home ,Remote ,Feasibility ,Tolerability ,Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Abstract
Introduction: The ability to deploy transcranial direct current stimulation (tDCS) at home is a key usability advantage to support scaling for pivotal clinical trials. We have established a home-based tDCS protocol for use in clinical trials termed remotely supervised (RS)-tDCS. Objective: To report the tolerability and feasibility of tDCS sessions completed to date using RS-tDCS in clinical trials. Methods: We analyzed tolerability (i.e., adverse events, AEs) reported in six Class I/II/III trials using RS-tDCS to study symptom outcomes over 10 to 60 daily applications. Across the six clinical trials, 308 participants (18–78 years old) completed an average of 23 sessions for a total of 6779 RS-tDCS administrations. The majority of participants were diagnosed with multiple sclerosis, and open-label trials included those diagnosed with a range of other conditions (e.g., Parkinson's disease, post-stroke aphasia, traumatic brain injury, cerebellar ataxia), with minimum-to-severe neurologic disability. Clinical trial feasibility (i.e., treatment fidelity and blinding integrity) was examined using two Class I randomized controlled trials (RCTs). Results: No serious AEs occurred. Across administrations, three sessions (0.04%) were aborted due to discomfort, but no participant discontinued due to tolerability. The AEs most commonly reported by participants were tingling (68%), itching (41%) and warmth sensation (42%) at the electrode site, and these were equally reported in active and sham tDCS conditions. The two Class I RCTs resulted in rapid enrollment, high fidelity to treatment completion, and blinding integrity. Conclusions: At-home RS-tDCS is tolerable, including when used over extended periods of time. Home-based RS-tDCS is feasible and can enable Class I tDCS clinical trial designs.
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- 2022
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9. Potential application of Transcranial Electrical Stimulation (tES) techniques in the context of covid-19 clinical course: From theory to real-world application
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Giuseppina Pilloni, Leigh Charvet, Abhishek Datta, and Marom Bikson
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Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Published
- 2023
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10. Remotely Supervised tDCS for Persistent Post-Traumatic Headache in Veterans (ReStore)
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Michelle Androulakis, Kiersten Mangold, Adam Harrison, Robert Davis Moore, Siyuan Guo, Jiajia Zhang, Abhishek Datta, Marom Bikson, and Leigh Charvet
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Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Published
- 2023
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11. Hand Dexterity Improves in Patients with Progressive Multiple Sclerosis (MS) with Telerehabilitation Using Transcranial Direct Current Stimulation (tDCS)
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Leigh Charvet, Giuseppina Pilloni, Matthew Lustberg, Martin Malik, Charles Feinberg, Josef Gutman, Lauren Krupp, and Preeti Raghavan
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Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Published
- 2023
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12. A single session of DLPFC tDCS modifies attention bias in depression
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Hyein Cho, Giuseppina Pilloni, Joerg Beringer, Amy Vogel-Eyny, Matthew Lustberg, and Leigh Charvet
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Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Published
- 2023
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13. At-home telehealth transcranial direct current stimulation for treatment resistant depression
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Amy Vogel-Eyny, Hyein Cho, Giuseppina Pilloni, Allan George, Matthew Lustberg, Abhishek Datta, Marom Bikson, Kamran Nazim, R. Erik Charlson, and Leigh Charvet
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Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Published
- 2023
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14. Cognitive Functioning in Multiple Sclerosis (MS) Improves with At-Home Online Training Paired with Transcranial Direct Current Stimulation (tDCS): Results from a Sham-Controlled Randomized Clinical Trial
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Leigh Charvet, Pamela Best, Matthew Lustberg, Giuseppina Pilloni, Michael Shaw, Lana Zhovtis, Xiaochun Li, Judith Goldberg, Josef Gutman, and Lauren Krupp
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Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Published
- 2023
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15. tDCS as telehealth intervention to reach patients with Post-Acute Sequelae of SARS-CoV-2 (PASC)
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Leigh Charvet, Giuseppina Pilloni, Allan George, Tehila Eilam-Stock, Matthew Lustberg, Abhishek Datta, and Marom Bikson
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Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Published
- 2023
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16. Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients
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Christopher J. Czura, Marom Bikson, Leigh Charvet, Jiande D. Z. Chen, Manfred Franke, Marat Fudim, Eric Grigsby, Sam Hamner, Jared M. Huston, Navid Khodaparast, Elliot Krames, Bruce J. Simon, Peter Staats, and Kristl Vonck
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vagus nerve (VN) stimulation ,sacral nerve electrical stimulation ,COVID-19 ,cytokine storm ,acute respiratory distress (ARDS) ,cranial nerve stimulation ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
Since the outbreak of the COVID-19 pandemic, races across academia and industry have been initiated to identify and develop disease modifying or preventative therapeutic strategies has been initiated. The primary focus has been on pharmacological treatment of the immune and respiratory system and the development of a vaccine. The hyperinflammatory state (“cytokine storm”) observed in many cases of COVID-19 indicates a prognostically negative disease progression that may lead to respiratory distress, multiple organ failure, shock, and death. Many critically ill patients continue to be at risk for significant, long-lasting morbidity or mortality. The human immune and respiratory systems are heavily regulated by the central nervous system, and intervention in the signaling of these neural pathways may permit targeted therapeutic control of excessive inflammation and pulmonary bronchoconstriction. Several technologies, both invasive and non-invasive, are available and approved for clinical use, but have not been extensively studied in treatment of the cytokine storm in COVID-19 patients. This manuscript provides an overview of the role of the nervous system in inflammation and respiration, the current understanding of neuromodulatory techniques from preclinical and clinical studies and provides a rationale for testing non-invasive neuromodulation to modulate acute systemic inflammation and respiratory dysfunction caused by SARS-CoV-2 and potentially other pathogens. The authors of this manuscript have co-founded the International Consortium on Neuromodulation for COVID-19 to advocate for and support studies of these technologies in the current coronavirus pandemic.
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- 2022
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17. Walking in multiple sclerosis improves with tDCS: a randomized, double‐blind, sham‐controlled study
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Giuseppina Pilloni, Claire Choi, Michael T Shaw, Giancarlo Coghe, Lauren Krupp, Marilyn Moffat, Eleonora Cocco, Massimiliano Pau, and Leigh Charvet
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Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
Abstract Objective To evaluate whether multiple sessions of transcranial direct current stimulation (tDCS) applied to the primary motor (M1) cortex paired with aerobic exercise can improve walking functions in multiple sclerosis (MS). Methods MS participants were recruited for a double‐blind, parallel‐arm, randomized, sham‐controlled trial and assigned to 10 sessions (5 d/wk for 2 weeks) of either active or sham tDCS paired with unloaded cycling for 20 minutes. Stimulation was administered over the left M1 cortex (2.5 mA; anode over C3/cathode over FP2). Gait spatiotemporal parameters were assessed using a wearable inertial sensor (10‐meter and 2‐minute walking tests). Measurements were collected at baseline, end of tDCS intervention, and 4‐week postintervention to test for duration of any benefits. Results A total of 15 participants completed the study, nine in the active and six in the sham condition. The active and sham groups were matched according to gender (50% vs. 40% female), neurologic disability (median EDSS 5.5 vs. 5), and age (mean 52.1 ± 12.9 vs. 53.7 ± 9.8 years). The active group had a significantly greater increase in gait speed (0.87 vs. 1.20 m/s, p
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- 2020
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18. Guidelines for TMS/tES clinical services and research through the COVID-19 pandemic
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Marom Bikson, Colleen A. Hanlon, Adam J. Woods, Bernadette T. Gillick, Leigh Charvet, Claus Lamm, Graziella Madeo, Adrienn Holczer, Jorge Almeida, Andrea Antal, Mohammad Reza Ay, Chris Baeken, Daniel M. Blumberger, Salvatore Campanella, Joan A. Camprodon, Lasse Christiansen, Colleen Loo, Jennifer T. Crinion, Paul Fitzgerald, Luigi Gallimberti, Peyman Ghobadi-Azbari, Iman Ghodratitoostani, Roland H. Grabner, Gesa Hartwigsen, Akimasa Hirata, Adam Kirton, Helena Knotkova, Evgeny Krupitsky, Paola Marangolo, Ester M. Nakamura-Palacios, Weronika Potok, Samir K. Praharaj, Christian C. Ruff, Gottfried Schlaug, Hartwig R. Siebner, Charlotte J. Stagg, Axel Thielscher, Nicole Wenderoth, Ti-Fei Yuan, Xiaochu Zhang, and Hamed Ekhtiari
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Non-invasive brain stimulation ,COVID-19 ,Transcranial magnetic stimulation ,Transcranial direct current stimulation ,Transcranial alternating current stimulation ,Transcranial electrical stimulation ,Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Abstract
Background: The COVID-19 pandemic has broadly disrupted biomedical treatment and research including non-invasive brain stimulation (NIBS). Moreover, the rapid onset of societal disruption and evolving regulatory restrictions may not have allowed for systematic planning of how clinical and research work may continue throughout the pandemic or be restarted as restrictions are abated. The urgency to provide and develop NIBS as an intervention for diverse neurological and mental health indications, and as a catalyst of fundamental brain research, is not dampened by the parallel efforts to address the most life-threatening aspects of COVID-19; rather in many cases the need for NIBS is heightened including the potential to mitigate mental health consequences related to COVID-19. Objective: To facilitate the re-establishment of access to NIBS clinical services and research operations during the current COVID-19 pandemic and possible future outbreaks, we develop and discuss a framework for balancing the importance of NIBS operations with safety considerations, while addressing the needs of all stakeholders. We focus on Transcranial Magnetic Stimulation (TMS) and low intensity transcranial Electrical Stimulation (tES) - including transcranial Direct Current Stimulation (tDCS) and transcranial Alternating Current Stimulation (tACS). Methods: The present consensus paper provides guidelines and good practices for managing and reopening NIBS clinics and laboratories through the immediate and ongoing stages of COVID-19. The document reflects the analysis of experts with domain-relevant expertise spanning NIBS technology, clinical services, and basic and clinical research – with an international perspective. We outline regulatory aspects, human resources, NIBS optimization, as well as accommodations for specific demographics. Results: A model based on three phases (early COVID-19 impact, current practices, and future preparation) with an 11-step checklist (spanning removing or streamlining in-person protocols, incorporating telemedicine, and addressing COVID-19-associated adverse events) is proposed. Recommendations on implementing social distancing and sterilization of NIBS related equipment, specific considerations of COVID-19 positive populations including mental health comorbidities, as well as considerations regarding regulatory and human resource in the era of COVID-19 are outlined. We discuss COVID-19 considerations specifically for clinical (sub-)populations including pediatric, stroke, addiction, and the elderly. Numerous case-examples across the world are described. Conclusion: There is an evident, and in cases urgent, need to maintain NIBS operations through the COVID-19 pandemic, including anticipating future pandemic waves and addressing effects of COVID-19 on brain and mind. The proposed robust and structured strategy aims to address the current and anticipated future challenges while maintaining scientific rigor and managing risk.
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- 2020
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19. Adverse childhood experiences predict reaction to multiple sclerosis diagnosis
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Tehila Eilam-Stock, Jon Links, Nabil Z. Khan, Tamar E. Bacon, Guadalupe Zuniga, Lisa Laing, Carrie Sammarco, Kathleen Sherman, and Leigh Charvet
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Psychology ,BF1-990 - Abstract
Objective At the time of multiple sclerosis (MS) diagnosis, identifying those at risk for poorer health-related quality of life and emotional well-being can be a critical consideration for treatment planning. This study aimed to test whether adverse childhood experiences predict MS patients’ health-related quality of life and emotional functioning at time of diagnosis and initial course of disease. Methods We recruited patients at the time of new MS diagnosis to complete self-report surveys at baseline and a one-year follow-up. Questionnaires included the Adverse Childhood Experiences (ACEs), as well as the MS Knowledge Questionnaire (MSKQ), the 36-Item Short Form Health Survey (SF-36), and Self-Management Screening (SeMaS). Results A total of n = 31 participants recently diagnosed with relapsing remitting MS (median EDSS = 1.0, age M = 33.84 ± 8.4 years) completed the study measures. The ACEs significantly predicted health-related quality of life (SF-36) at baseline (Adjusted R 2 = 0.18, p = 0.011) and follow-up (Adjusted R 2 = 0.12, p = 0.03), baseline scores on the SeMaS Depression scale (Adjusted R 2 = 0.19, p = 0.008), as well as follow-up scores on the SeMaS Anxiety (Adjusted R 2 = 0.19, p = 0.014) and SeMaS Depression (Adjusted R 2 = 0.14, p = 0.036) scales. Importantly, increased ACEs scores were predictive of increased anxiety at the one-year follow-up assessment, compared to baseline. Conclusions Childhood adversity predicts health-related quality of life and emotional well-being at time of MS diagnosis and over the initial course of the disease. Measured using a brief screening inventory (ACEs), routine administration may be useful for identifying patients in need of increased supportive services.
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- 2021
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20. Mobile Attention Bias Modification Training Is a Digital Health Solution for Managing Distress in Multiple Sclerosis: A Pilot Study in Pediatric Onset
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Leigh Charvet, Allan George, Hyein Cho, Lauren B. Krupp, and Tracy A. Dennis-Tiwary
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multiple sclerosis ,pediatric onset multiple sclerosis ,pediatric neurology ,attention bias modification training ,anxiety ,distress ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
Introduction: Emotional health is important dimension of care for patients living with pediatric onset multiple sclerosis (POMS), but few options are available for stress and anxiety reduction. The high burden of interventions requiring regular in person and onsite visits for treatment are less feasible. Attention bias modification training (ABMT) is effective for anxiety reduction in adult and adolescent populations. We tested the feasibility and preliminary efficacy of ABMT delivered through a mobile gamified version as a digital emotional health tool for patients with POMS.Methods: Participants with POMS were consecutively recruited from the NYU Langone Pediatric MS Care Center and enrolled to complete a 1-month intervention with use of the Personal Zen ABMT app on their mobile personal device. Feasibility was evaluated by use of the 1-month intervention and efficacy was measured by changes in depression, anxiety, and affect.Results: A total n = 35 patients with POMS were enrolled in the study (Mage = 17.7, SD = 2.2 years, range 14–23). Feasibility criteria were met with 74% completing the full intervention time, and 100% of the sample completing at least 50% of targeted intervention use. Initial efficacy was found for a reduction in negative affect from baseline to intervention end [M = 22.88, SD = 9.95 vs. M = 19.56, SD = 7.37; t(33) = 2.47, p = 0.019]. Anxiety also significantly decreased from pre to post-intervention in adults [M = 11.82, SD = 9.90 vs. M = 7.29, SD = 7.17; t(16) = 3.88, p = 0.001] and youth [M = 51.14, SD = 19.66 vs. M = 40.86, SD = 27.48; t(13) = 3.17, p = 0.007].Conclusion: Mobile ABMT with the Personal Zen app is a feasible and accessible digital emotional health tool for patients with POMS and may have broader application for managing distress across chronic neurological conditions.
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- 2021
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21. Generalizing remotely supervised transcranial direct current stimulation (tDCS): feasibility and benefit in Parkinson’s disease
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Bryan Dobbs, Natalie Pawlak, Milton Biagioni, Shashank Agarwal, Michael Shaw, Giuseppina Pilloni, Marom Bikson, Abhishek Datta, and Leigh Charvet
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Transcranial direct current stimulation ,tDCS ,Telerehabilitation ,Parkinson’s disease ,Multiple sclerosis ,Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Abstract
Abstract Background Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has been shown to improve common symptoms of neurological disorders like depressed mood, fatigue, motor deficits and cognitive dysfunction. tDCS requires daily treatment sessions in order to be effective. We developed a remotely supervised tDCS (RS-tDCS) protocol for participants with multiple sclerosis (MS) to increase accessibility of tDCS, reducing clinician, patient, and caregiver burden. The goal of this protocol is to facilitate home use for larger trials with extended treatment periods. In this study we determine the generalizability of RS-tDCS paired with cognitive training (CT) by testing its feasibility in participants with Parkinson’s disease (PD). Methods Following the methods in our MS protocol development, we enrolled sixteen participants (n = 12 male, n = 4 female; mean age 66 years) with PD to complete ten open-label sessions of RS-tDCS paired with CT (2.0 mA × 20 min) at home under the remote supervision of a trained study technician. Tolerability data were collected before, during, and after each individual session. Baseline and follow-up measures included symptom inventories (fatigue and sleep) and cognitive assessments. Results RS-tDCS was feasible and tolerable for patients with PD, with at-home access leading to high protocol compliance. Side effects were mostly limited to mild sensations of transient itching and burning under the electrode sites. Similar to prior finding sin MS, we found preliminary efficacy for improvement of fatigue and cognitive processing speed in PD. Conclusions RS-tDCS paired with CT is feasible for participants with PD to receive at home treatment. Signals of benefit for reduced fatigue and improved cognitive processing speed are consistent across the PD and MS samples. RS-tDCS can be generalized to provide tDCS to a range of patients with neurologic disorders for at-home rehabilitation. Trial registration ClinicalTrials.gov Identifier: NCT02746705. Registered April 21st 2016.
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- 2018
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22. No risk of skin lesion or burn with transcranial direct current stimulation (tDCS) using standardized protocols
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Giuseppina Pilloni, Adam J. Woods, and Leigh Charvet
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Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Published
- 2021
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23. Gray Matter Morphometry Correlates with Attentional Efficiency in Young-Adult Multiple Sclerosis
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Sindhuja T. Govindarajan, Ruiqi Pan, Lauren Krupp, Leigh Charvet, and Tim Q. Duong
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pediatric-onset multiple sclerosis ,cognition ,executive control ,attention ,atrophy ,cortical thickness ,Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 - Abstract
Slowed processing on the alerting, orienting and executive control components of attention measured using the Attention Network Test-Interactions (ANT-I) have been widely reported in multiple sclerosis (MS). Despite the assumption that these components correspond to specific neuroanatomical networks in the brain, little is known about gray matter changes that occur in MS and their association with ANT-I performance. We investigated vertex-wise cortical thickness changes and deep gray matter volumetric changes in young MS participants (N = 21, age range: 18–35) with pediatric or young-adult onset and mild disease severity. ANT-I scores and cortical thickness were not significantly different between MS participants and healthy volunteers (N = 19, age range: 18–35), but thalamic volumes were significantly lower in MS. Slowed reaction times on the alerting component in MS correlated significantly with reduced volume of the right pallidum in MS. Slowed reaction times on executive control component correlated significantly with reduced thickness in the frontal, parietal and visual cortical areas and with reduced volume of the left putamen in MS. These findings demonstrate associations between gray matter changes and attentional performance even in the absence of widespread atrophy or slowed attentional processes.
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- 2021
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24. 'Data Is One Thing, But I Want To Know The Story Behind': Designing For Self-Tracking and Remote Patient Monitoring In The Context Of Multiple Sclerosis Care.
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Graham Dove, Marina Roos Guthmann, Leigh Charvet, Oded Nov, and Giuseppina Pilloni
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- 2024
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25. 'Are They Doing Better In The Clinic Or At Home?': Understanding Clinicians' Needs When Visualizing Wearable Sensor Data Used In Remote Gait Assessments For People With Multiple Sclerosis.
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Ayanna Seals, Giuseppina Pilloni, Jin Kim, Raul Sanchez, John-Ross Rizzo, Leigh Charvet, Oded Nov, and Graham Dove
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- 2022
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26. Is Fatigue Response to tDCS Mediated by Change in Affect? An Open-label tDCS-MRI Study (S27.010)
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Giuseppina Pilloni, Lillian Walton Masters, Marco Muccio, Claire Choi, Abhishek Datta, Marom Bikson, Lauren Krupp, Yulin Ge, and Leigh Charvet
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- 2023
27. Longitudinal Cognitive Screening Findings in Pediatric MS vs. Pediatric Controls and Adult MS in a Multi-center Cohort (S31.008)
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Kimberly O’Neill, Leigh Charvet, Michael Waltz, Theron Casper, Allan George, Leslie Benson, Mark Gorman, Manu Goyal, Soe Mar, Jayne Ness, Teri Schreiner, Emmanuelle Waubant, Bianca Weinstock-Guttman, Yolanda Wheeler, Gregory Aaen, Aaron Abrams, Tanuja Chitnis, Timothy Lotze, Mary Rensel, Moses Rodriguez, John Rose, Nikita Shukla, Jan-Mendelt Tillema, and Lauren Krupp
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- 2023
28. Remotely Supervised tDCS for Persistent Post-Traumatic Headache in Veterans (ReStore) (P7-1.004)
- Author
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Leigh Charvet, Kiersten Mangold, Adam Harrison, Robert Davis Moore, Siyuan Guo, Jiajia Zhang, Abhishek Datta, and Michelle Androulakis
- Published
- 2023
29. Real-world effectiveness of switching treatment after initial platform injectable disease-modifying therapies in pediatric multiple sclerosis in the US (P14-3.008)
- Author
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Aaron Abrams, Michael Waltz, Theron Casper, Gregory Aaen, Leslie Benson, Leigh Charvet, Tanuja Chitnis, Carla Francisco, Mark Gorman, Manu Goyal, Jennifer Graves, Lauren Krupp, Timothy Lotze, Soe Mar, Mary Rensel, Moses Rodriguez, John Rose, Alice Rutatangwa, Teri Schreiner, Nikita Shukla, Jan-Mendelt Tillema, Bianca Weinstock-Guttman, Yolanda Wheeler, Emmanuelle Waubant, and Kristen Krysko
- Published
- 2023
30. Vigilance Improves in People with Multiple Sclerosis (MS) and Fatigue following Repeated Dorsolateral Prefrontal Cortex Transcranial Direct Current Stimulation (tDCS) Sessions Paired with Cognitive Training Delivered at Home (S38.003)
- Author
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Leigh Charvet, Lillian Walton Masters, Claire Choi, Marco Muccio, Yulin Ge, Lauren Krupp, and Giuseppina Pilloni
- Published
- 2023
31. Feasibility of Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) for People with Stroke-Induced and Progressive Aphasia
- Author
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Jessica D. Richardson, Elizabeth E. Galletta, Leigh Charvet, and Michael Shaw
- Subjects
Linguistics and Language ,Neurology ,Otorhinolaryngology ,Developmental and Educational Psychology ,Neurology (clinical) ,LPN and LVN ,Language and Linguistics - Published
- 2022
32. Association of Disease Severity and Socioeconomic Status in Black and White Americans With Multiple Sclerosis
- Author
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Kathryn C. Fitzgerald, Karla Gray-Roncal, Sandra D. Cassard, Lana Zhovtis Ryerson, Kedar R Mahajan, Ellen M. Mowry, Robert T. Naismith, Daniel Ontaneda, Leigh Charvet, and Wanda Castro-Borrero
- Subjects
Adult ,Male ,Multiple Sclerosis ,Severity of Illness Index ,White People ,Odds ,Humans ,Medicine ,Association (psychology) ,Socioeconomic status ,business.industry ,Multiple sclerosis ,Brain ,Cognition ,Middle Aged ,medicine.disease ,Confidence interval ,Black or African American ,Social Class ,Cohort ,Female ,Neurology (clinical) ,business ,Medicaid ,Research Article ,Demography - Abstract
ObjectiveTo compare clinical and imaging features of multiple sclerosis (MS) severity between Black Americans (BAs) and White Americans (WAs) and to evaluate the role of socioeconomic status.MethodsWe compared BA and WA participants in the Multiple Sclerosis Partners Advancing Technology Health Solutions (MS PATHS) cohort with respect to MS characteristics, including self-reported disability, objective neurologic function assessments, and quantitative brain MRI measurements, after covariate adjustment (including education level, employment, or insurance as socioeconomic indicators). In a subgroup, we evaluated within-race, neighborhood-level indicators of socioeconomic status (SES) using 9-digit zip codes.ResultsOf 1,214 BAs and 7,530 WAs with MS, BAs were younger, had lower education level, and were more likely to have Medicaid insurance or to be disabled or unemployed than WAs. BAs had worse self-reported disability (1.47-fold greater odds of severe vs mild disability, 95% confidence interval [CI] 1.18, 1.86) and worse performances on tests of cognitive processing speed (−5.06 fewer correct, 95% CI −5.72, −4.41), walking (0.66 seconds slower, 95% CI 0.36, 0.96), and manual dexterity (2.11 seconds slower, 95% CI 1.69, 2.54). BAs had more brain MRI lesions and lower overall and gray matter brain volumes, including reduced thalamic (−0.77 mL, 95% CI −0.91, −0.64), cortical (−30.63 mL, 95% CI −35.93, −25.33), and deep (−1.58 mL, 95% CI −1.92, −1.23) gray matter volumes. While lower SES correlated with worse neuroperformance scores in WAs, this association was less clear in BAs.ConclusionWe observed a greater burden of disease in BAs with MS relative to WAs with MS, despite adjustment for SES indicators. Beyond SES, future longitudinal studies should also consider roles of other societal constructs (e.g., systemic racism). Such studies will be important for identifying prognostic factors; developing optimal treatment strategies among BAs with MS is warranted.
- Published
- 2021
33. Enhancing Mood, Cognition, and Quality of Life in Pediatric Multiple Sclerosis
- Author
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Leigh Charvet, Cristina Fernandez-Carbonell, and Lauren B. Krupp
- Subjects
Multiple Sclerosis ,Adolescent ,Saturated fat ,Psychological intervention ,Medical Marijuana ,Leading Article ,Disease ,Antioxidants ,03 medical and health sciences ,Cognition ,0302 clinical medicine ,Quality of life (healthcare) ,Humans ,Medicine ,Pharmacology (medical) ,Longitudinal Studies ,Vitamin D ,Disease management (health) ,Child ,Exercise ,Fatigue ,030203 arthritis & rheumatology ,Sleep hygiene ,business.industry ,Multiple sclerosis ,Disease Management ,medicine.disease ,Affect ,Mood ,Pediatrics, Perinatology and Child Health ,Quality of Life ,business ,030217 neurology & neurosurgery ,Clinical psychology - Abstract
Pediatric-onset multiple sclerosis (POMS), representing approximately 5% of all MS cases, affects the central nervous system during its ongoing development. POMS is most commonly diagnosed during adolescence but can occur in younger children as well. For pediatric patients with MS, it is critical to manage the full impact of the disease and monitor for any effects on school and social functioning. Disease management includes not only disease-modifying therapies but also strategies to optimize wellbeing. We review the interventions with the highest evidence of ability to improve the disease course and quality of life in POMS. High levels of vitamin D and a diet low in saturated fat are associated with lower relapse rates. Exercise ameliorates fatigue and sleep. Behavioral strategies for sleep hygiene and mood regulation can also improve fatigue and perceived health. POMS management should be addressed holistically, including assessing overall symptom burden as well as the psychological and functional impact of the disease.
- Published
- 2021
34. A Systematic Review and Meta-Analysis on the Efficacy of Repeated Transcranial Direct Current Stimulation for Migraine
- Author
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Feifei Xiao, Zhu Xia, Abhishek Datta, Guoshuai Cai, X. Michelle Androulakis, and Leigh Charvet
- Subjects
medicine.medical_treatment ,Stimulation ,Subgroup analysis ,Review ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,030202 anesthesiology ,law ,Medicine ,migraine ,Migraine treatment ,transcranial direct current stimulation (tDCS) ,Transcranial direct-current stimulation ,business.industry ,medicine.disease ,Intensity (physics) ,meta-analysis ,Anesthesiology and Pain Medicine ,Migraine ,Anesthesia ,Meta-analysis ,neuromodulation ,business ,030217 neurology & neurosurgery - Abstract
Purpose Transcranial direct current stimulation (tDCS) may have therapeutic potential in the management of migraine. However, studies to date have yielded conflicting results. We reviewed studies using repeated tDCS for longer than 4 weeks in migraine treatment, and performed meta-analysis on the efficacy of tDCS in migraine. Methods In this meta-analysis, we included the common outcome measurements reported across randomized controlled trials (RCTs). Subgroup analysis was performed at different post-treatment endpoints, and with different stimulation intensities and polarities. Results Five RCTs were included in the quantitative meta-analysis with a total of 104 migraine patients. We found a significant reduction of migraine pain intensity (MD: -1.44; CI: [-2.13, -0.76]) in active vs sham tDCS treated patients. Within active treatment groups, pain intensity and duration were significantly improved from baseline after tDCS treatment (intensity MD: -1.86; CI: [-3.30, -0.43]; duration MD: -4.42; CI: [-8.11, -0.74]) and during a follow-up period (intensity MD: -1.52; CI: [-1.84, -1.20]; duration MD: -1.94; CI: [-3.10, -0.77]). There was a significant reduction of pain intensity by both anodal (MD: -1.74; CI: [-2.80, -0.68]) and cathodal (MD: -1.49; CI: [-1.89, -1.09]) stimulation conditions. Conclusion tDCS treatment repeated over days for a period of 4 weeks or more is effective in reducing migraine pain intensity and duration of migraine episode. The benefit of tDCS can persist for at least 4 weeks after the completion of last tDCS session. Both anodal and cathodal stimulation are effective for reducing migraine pain intensity.
- Published
- 2021
35. Telehealth transcranial direct current stimulation for recovery from Post-Acute Sequelae of SARS-CoV-2 (PASC)
- Author
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Lauren Krupp, Matthew Lustberg, Robyn Wolintz, Leigh Charvet, Tehila Eilam-Stock, and Allan George
- Subjects
2019-20 coronavirus outbreak ,medicine.medical_specialty ,Transcranial direct-current stimulation ,Coronavirus disease 2019 (COVID-19) ,SARS-CoV-2 ,business.industry ,General Neuroscience ,medicine.medical_treatment ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Biophysics ,COVID-19 ,Neurosciences. Biological psychiatry. Neuropsychiatry ,Telehealth ,Transcranial Direct Current Stimulation ,Article ,Telemedicine ,Emergency medicine ,Disease Progression ,medicine ,Humans ,Neurology (clinical) ,business ,RC321-571 - Published
- 2021
36. Digitalized transcranial electrical stimulation: A consensus statement
- Author
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Andre R Brunoni, Hamed Ekhtiari, Andrea Antal, Paradee Auvichayapat, Chris Baeken, Isabela M. Benseñor, Marom Bikson, Paulo Boggio, Barbara Borroni, Filippo Brighina, Jerome Brunelin, Sandra Carvalho, Wolnei Caumo, Patrick Ciechanski, Leigh Charvet, Vincent P. Clark, Roi Cohen Kadosh, Maria Cotelli, Abhishek Datta, Zhi-De Deng, Rudi De Raedt, Dirk De Ridder, Paul B. Fitzgerald, Agnes Floel, Flavio Frohlich, Mark S. George, Peyman Ghobadi-Azbari, Stephan Goerigk, Roy H. Hamilton, Shapour J. Jaberzadeh, Kate Hoy, Dawson J. Kidgell, Arash Khojasteh Zonoozi, Adam Kirton, Steven Laureys, Michal Lavidor, Kiwon Lee, Jorge Leite, Sarah H. Lisanby, Colleen Loo, Donel M. Martin, Carlo Miniussi, Marine Mondino, Katia Monte-Silva, Leon Morales-Quezada, Michael A. Nitsche, Alexandre H. Okano, Claudia S. Oliveira, Balder Onarheim, Kevin Pacheco-Barrios, Frank Padberg, Ester M. Nakamura-Palacios, Ulrich Palm, Walter Paulus, Christian Plewnia, Alberto Priori, Tarek K. Rajji, Lais B. Razza, Erik M. Rehn, Giulio Ruffini, Klaus Schellhorn, Mehran Zare-Bidoky, Marcel Simis, Pawel Skorupinski, Paulo Suen, Aurore Thibaut, Leandro C.L. Valiengo, Marie-Anne Vanderhasselt, Sven Vanneste, Ganesan Venkatasubramanian, Ines R. Violante, Anna Wexler, Adam J. Woods, Felipe Fregni, Brain, Body and Cognition, Clinical sciences, Neuroprotection & Neuromodulation, Psychiatry, Brunoni, Andre R, Ekhtiari, Hamed, Antal, Andrea, Auvichayapat, Paradee, Baeken, Chri, Benseñor, Isabela M, Bikson, Marom, Boggio, Paulo, Borroni, Barbara, Brighina, Filippo, Brunelin, Jerome, Carvalho, Sandra, Caumo, Wolnei, Ciechanski, Patrick, Charvet, Leigh, Clark, Vincent P, Cohen Kadosh, Roi, Cotelli, Maria, Datta, Abhishek, Deng, Zhi-De, De Raedt, Rudi, De Ridder, Dirk, Fitzgerald, Paul B, Floel, Agne, Frohlich, Flavio, George, Mark S, Ghobadi-Azbari, Peyman, Goerigk, Stephan, Hamilton, Roy H, Jaberzadeh, Shapour J, Hoy, Kate, Kidgell, Dawson J, Zonoozi, Arash Khojasteh, Kirton, Adam, Laureys, Steven, Lavidor, Michal, Lee, Kiwon, Leite, Jorge, Lisanby, Sarah H, Loo, Colleen, Martin, Donel M, Miniussi, Carlo, Mondino, Marine, Monte-Silva, Katia, Morales-Quezada, Leon, Nitsche, Michael A, Okano, Alexandre H, Oliveira, Claudia S, Onarheim, Balder, Pacheco-Barrios, Kevin, Padberg, Frank, Nakamura-Palacios, Ester M, Palm, Ulrich, Paulus, Walter, Plewnia, Christian, Priori, Alberto, Rajji, Tarek K, Razza, Lais B, Rehn, Erik M, Ruffini, Giulio, Schellhorn, Klau, Zare-Bidoky, Mehran, Simis, Marcel, Skorupinski, Pawel, Suen, Paulo, Thibaut, Aurore, Valiengo, Leandro C L, Vanderhasselt, Marie-Anne, Vanneste, Sven, Venkatasubramanian, Ganesan, Violante, Ines R, Wexler, Anna, Woods, Adam J, and Fregni, Felipe
- Subjects
Mobile Health ,Consensus ,Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA ,Clinical psychology ,methods [Transcranial Direct Current Stimulation] ,Transcranial Direct Current Stimulation ,Sensory Systems ,Electric Stimulation ,Telemedicine ,Psychiatry and Mental health ,Neurology ,Physiology (medical) ,Delphi panel ,Systematic review ,Humans ,Non-invasive neuromodulation ,Neurology (clinical) ,ddc:610 ,Digital health - Abstract
Objective: Although relatively costly and non-scalable, non-invasive neuromodulation interventions are treatment alternatives for neuropsychiatric disorders. The recent developments of highly-deployable transcranial electric stimulation (tES) systems, combined with mobile-Health technologies, could be incorporated in digital trials to overcome methodological barriers and increase equity of access. The study aims are to discuss the implementation of tES digital trials by performing a systematic scoping review and strategic process mapping, evaluate methodological aspects of tES digital trial designs, and provide Delphi-based recommendations for implementing digital trials using tES.Methods: We convened 61 highly-productive specialists and contacted 8 tES companies to assess 71 issues related to tES digitalization readiness, and processes, barriers, advantages, and opportunities for implementing tES digital trials. Delphi-based recommendations (>60% agreement) were provided.Results: The main strengths/opportunities of tES were: (i) non-pharmacological nature (92% of agreement), safety of these techniques (80%), affordability (88%), and potential scalability (78%). As for weaknesses/threats, we listed insufficient supervision (76%) and unclear regulatory status (69%). Many issues related to methodological biases did not reach consensus. Device appraisal showed moderate digitalization readiness, with high safety and potential for trial implementation, but low connectivity.Conclusions: Panelists recognized the potential of tES for scalability, generalizability, and leverage of digital trials processes; with no consensus about aspects regarding methodological biases. Significance: We further propose and discuss a conceptual framework for exploiting shared aspects between mobile-Health tES technologies with digital trials methodology to drive future efforts for digitizing tES trials. (C) 2022 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.
- Published
- 2022
37. Moving intra-individual variability (IIV) towards clinical utility: IIV measured using a commercial testing platform
- Author
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Hyein Cho, Giuseppina Pilloni, Raisa Tahsin, Pamela Best, Lauren Krupp, Cheongeun Oh, and Leigh Charvet
- Subjects
Neurology ,Neurology (clinical) - Published
- 2023
38. Walking in multiple sclerosis improves with tDCS: a randomized, double‐blind, sham‐controlled study
- Author
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Eleonora Cocco, Massimiliano Pau, Lauren B. Krupp, Giuseppina Pilloni, Michael Shaw, Leigh Charvet, Claire Choi, Giancarlo Coghe, and Marilyn Moffat
- Subjects
0301 basic medicine ,Adult ,Male ,medicine.medical_specialty ,Multiple Sclerosis ,medicine.medical_treatment ,Neurosciences. Biological psychiatry. Neuropsychiatry ,Walking ,Transcranial Direct Current Stimulation ,Severity of Illness Index ,law.invention ,Placebos ,03 medical and health sciences ,0302 clinical medicine ,Physical medicine and rehabilitation ,Randomized controlled trial ,Double-Blind Method ,law ,Severity of illness ,Outcome Assessment, Health Care ,medicine ,Aerobic exercise ,Humans ,RC346-429 ,Lead (electronics) ,Research Articles ,Aged ,Transcranial direct-current stimulation ,business.industry ,General Neuroscience ,Multiple sclerosis ,Motor Cortex ,Middle Aged ,medicine.disease ,Gait ,Combined Modality Therapy ,Exercise Therapy ,030104 developmental biology ,medicine.anatomical_structure ,Female ,Neurology. Diseases of the nervous system ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,RC321-571 ,Motor cortex ,Research Article - Abstract
Objective To evaluate whether multiple sessions of transcranial direct current stimulation (tDCS) applied to the primary motor (M1) cortex paired with aerobic exercise can improve walking functions in multiple sclerosis (MS). Methods MS participants were recruited for a double‐blind, parallel‐arm, randomized, sham‐controlled trial and assigned to 10 sessions (5 d/wk for 2 weeks) of either active or sham tDCS paired with unloaded cycling for 20 minutes. Stimulation was administered over the left M1 cortex (2.5 mA; anode over C3/cathode over FP2). Gait spatiotemporal parameters were assessed using a wearable inertial sensor (10‐meter and 2‐minute walking tests). Measurements were collected at baseline, end of tDCS intervention, and 4‐week postintervention to test for duration of any benefits. Results A total of 15 participants completed the study, nine in the active and six in the sham condition. The active and sham groups were matched according to gender (50% vs. 40% female), neurologic disability (median EDSS 5.5 vs. 5), and age (mean 52.1 ± 12.9 vs. 53.7 ± 9.8 years). The active group had a significantly greater increase in gait speed (0.87 vs. 1.20 m/s, p
- Published
- 2020
39. Digitizing Non-Invasive Neuromodulation Trials: Scoping Review, Process Mapping, and Recommendations from a Delphi Panel
- Author
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Andre R Brunoni, Hamed Ekhtiari, Andrea Antal, Paradee Auvichayapat, Chris Baeken, Isabela M. Benseñor, Marom Bikson, Paulo Boggio, Barbara Borroni, Filippo Brighina, Jerome Brunelin, Sandra Carvalho, Wolnei Caumo, Patrick Ciechanski, Leigh Charvet, Vincent P. Clark, Roi Cohen Kadosh, Maria Cotelli, Abhishek Datta, Zhi-De Deng, Rudi De Raedt, Dirk De Ridder, Paul B. Fitzgerald, Agnes Floel, Flavio Frohlich, Mark S. George, Peyman Ghobadi-Azbari, Stephan Goerigk, Roy H. Hamilton, Shapour J. Jaberzadeh, Kate Hoy, Dawson J. Kidgell, Arash Khojasteh Zonoozi, Adam Kirton, Steven Laureys, Michal Lavidor, Kiwon Lee, Jorge Leite, Sarah H. Lisanby, Colleen Loo, Donel M. Martin, Carlo Miniussi, Marine Mondino, Katia Monte-Silva, Leon Morales-Quezada, Michael A. Nitsche, Alexandre H. Okano, Claudia S. Oliveira, Balder Onarheim, Kevin Pacheco-Barrios, Frank Padberg, Ester M Nakamura-Palacios, Ulrich Palm, Walter Paulus, Christian Plewnia, Alberto Priori, Tarek K. Rajji, Lais B. Razza, Erik M. Rehn, Giulio Ruffini, Klaus Schellhorn, Mehran Zare-Bidoky, Marcel Simis, Pawel Skorupinski, Paulo Suen, Aurore Thibaut, Leandro C. L. Valiengo, Marie-Anne Vanderhasselt, Sven Vanneste, Ganesan Venkatasubramanian, Ines R. Violante, Anna Wexler, Adam J. Woods, and Felipe Fregni
- Subjects
History ,Polymers and Plastics ,Business and International Management ,Industrial and Manufacturing Engineering - Abstract
Although relatively costly and non-scalable, non-invasive neuromodulation interventions are treatment alternatives for neuropsychiatric disorders. The recent developments of highly-deployable transcranial electric stimulation (tES) systems, combined with mobile-Health technologies, could be incorporated in digital trials to overcome methodological barriers and increase equity of access. We convened 61 highly-productive specialists and contacted 8 tES companies to assess 71 issues related to tES digitalization readiness, and processes, barriers, advantages, and opportunities for implementing tES digital trials. Delphi-based recommendations (>60% agreement) were provided. Device appraisal showed moderate digitalization readiness, with high safety and the possibility of trial implementation, but low connectivity. Panelists recognized the potential of tES for scalability, generalizability, and leverage of digital trials processes; although they reached no consensus about aspects regarding methodological biases. We further propose and discuss a conceptual framework for exploiting shared aspects between mobile-Health tES technologies with digital trials methodology to drive future efforts for digitizing tES trials.Graphical Abstract. Consensus Roadmap(A) Recruitment process. The study procedure started with defining the components of the research problem by the core research team. After defining the problems, two different sets of participants (the steering committee (SC) including key leaders of the field identified by the core team and the expert panel (EP) as a more diverse group of experts identified based on the number of publications based on a systematic review) were identified and were invited to participate in a Delphi study. The study facilitators (first and last authors) led the communications with the SC to design the initial questionnaire through an iterative approach. (B) Evidence synthesis: To collect the available evidence, companies producing portable tES (ptES) devices were contacted, based on the companies suggested by the SC and EP to provide details about the available devices. For mapping methodological processes of digitizing tES trials, two distinct strategies were performed and embedded into the questionnaire, namely SIPOC (Suppliers, Inputs, Process, Outputs, and Customer) and SWOT (Strengths, Weaknesses, Opportunities, and Threats) assessment were performed and embedded into the questionnaire. (C) Consensus development: In the next phase, the questionnaire was validated and finalized via collecting and summarizing opinions. Afterward, the SC and EP responded to the final questionnaire, and results were analyzed providing a list of recommendations for running tES digital trials based on a pre-registered consensus threshold.
- Published
- 2022
40. Cognitive Telerehabilitation with Transcranial Direct Current Stimulation Improves Cognitive and Emotional Functioning Following a Traumatic Brain Injury: A Case Study
- Author
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Leigh Charvet, Tehila Eilam-Stock, and Allan George
- Subjects
Adult ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,Neuropsychological Tests ,Transcranial Direct Current Stimulation ,050105 experimental psychology ,Young Adult ,03 medical and health sciences ,Cognition ,0302 clinical medicine ,Physical medicine and rehabilitation ,Brain Injuries, Traumatic ,Humans ,Medicine ,0501 psychology and cognitive sciences ,Telerehabilitation ,Rehabilitation ,Transcranial direct-current stimulation ,business.industry ,Working memory ,05 social sciences ,Neuropsychology ,General Medicine ,Cognitive training ,Dorsolateral prefrontal cortex ,Psychiatry and Mental health ,Clinical Psychology ,Memory, Short-Term ,Neuropsychology and Physiological Psychology ,medicine.anatomical_structure ,Cognitive remediation therapy ,business ,030217 neurology & neurosurgery - Abstract
Objective Cognitive deficits following a traumatic brain injury (TBI) are a leading cause of disability in young adults and there is a critical need for novel approaches to improve cognitive outcomes in TBI survivors. Transcranial direct current stimulation (tDCS) paired with cognitive remediation has emerged as a viable, cost-effective, noninvasive approach for treating cognitive impairments in a wide variety of neurological conditions. Here, we report the first case study utilizing remotely supervised tDCS (RS-tDCS) protocol paired with cognitive remediation in a 29-year-old man with persisting cognitive and emotional sequelae following TBI. Method Neuropsychological measures were administered before and after the patient completed 20 daily sessions of RS-tDCS (2.0 mA × 20 minutes, left anodal dorsolateral prefrontal cortex montage). During the daily stimulation period, he completed adaptive cognitive training. All treatment procedures were delivered at home and monitored in real time via videoconference with a study technician. Results Following 20 RS-tDCS and cognitive training sessions, he had significant improvements (>1 SD) on tests of attention and working memory, semantic fluency, and information processing speed. Mood was also improved. Conclusions This is the first demonstration of at-home telerehabilitation with RS-tDCS and cognitive training to improve cognitive outcomes following TBI.
- Published
- 2020
41. White matter correlates of slowed information processing speed in unimpaired multiple sclerosis patients with young age onset
- Author
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Yilin Liu, Lev Bangiyev, Maria Andrea Parra Corral, Sindhuja T. Govindarajan, Lauren Krupp, Timothy Q. Duong, and Leigh Charvet
- Subjects
Elementary cognitive task ,medicine.medical_specialty ,Multiple Sclerosis ,Cognitive Neuroscience ,Audiology ,Corpus callosum ,050105 experimental psychology ,White matter ,03 medical and health sciences ,Behavioral Neuroscience ,Cellular and Molecular Neuroscience ,Cognition ,0302 clinical medicine ,Fasciculus ,Fractional anisotropy ,medicine ,Humans ,0501 psychology and cognitive sciences ,Radiology, Nuclear Medicine and imaging ,Child ,biology ,business.industry ,Multiple sclerosis ,05 social sciences ,Neuropsychology ,medicine.disease ,biology.organism_classification ,Magnetic Resonance Imaging ,White Matter ,Psychiatry and Mental health ,Diffusion Tensor Imaging ,medicine.anatomical_structure ,Neurology ,Anisotropy ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Diffusion MRI - Abstract
Slowed information processing speed is among the earliest markers of cognitive impairment in multiple sclerosis (MS) and has been associated with white matter (WM) structural integrity. Localization of WM tracts associated with slowing, but not significant impairment, on specific cognitive tasks in pediatric and young age onset MS can facilitate early and effective therapeutic intervention. Diffusion tensor imaging data were collected on 25 MS patients and 24 controls who also underwent the Symbol Digit Modalities Test (SDMT) and the computer-based Cogstate simple and choice reaction time tests. Fractional anisotropy (FA), mean (MD), radial (RD) and axial (AD) diffusivities were correlated voxel-wise with processing speed measures. All DTI metrics of several white matter tracts were significantly different between groups (p
- Published
- 2020
42. Functional Connectivity and Structural Disruption in the Default‐Mode Network Predicts Cognitive Rehabilitation Outcomes in Multiple Sclerosis
- Author
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Amy Kuceyeski, Devon Oship, Alexander Bartnik, Leigh Charvet, Tom A. Fuchs, Robert Zivadinov, Stefano Ziccardi, Rebecca Campbell, Bianca Weinstock-Guttman, Jose Escobar, Hoan Duc Tran, Curtis Wojcik, David Hojnacki, Niels Bergsland, Ralph H.B. Benedict, Michael G. Dwyer, Dejan Jakimovski, and Channa Kolb
- Subjects
Adult ,Male ,medicine.medical_specialty ,Multiple Sclerosis ,Precuneus ,Neuropsychological Tests ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,Cognition ,0302 clinical medicine ,Physical medicine and rehabilitation ,cognitive rehabilitation ,functional MRI ,multiple sclerosis ,network ,prediction ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Cognitive rehabilitation therapy ,Default mode network ,Aged ,Cognitive reserve ,medicine.diagnostic_test ,business.industry ,Multiple sclerosis ,Brain ,Default Mode Network ,Repeated measures design ,Magnetic resonance imaging ,Middle Aged ,medicine.disease ,Magnetic Resonance Imaging ,White Matter ,Treatment Outcome ,medicine.anatomical_structure ,Posterior cingulate ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Abstract
Background and purpose Efficacy of restorative cognitive rehabilitation can be predicted from baseline patient factors. In addition, patient profiles of functional connectivity are associated with cognitive reserve and moderate the structure-cognition relationship in people with multiple sclerosis (PwMS). Such interactions may help predict which PwMS will benefit most from cognitive rehabilitation. Our objective was to determine whether patient response to restorative cognitive rehabilitation is predictable from baseline structural network disruption and whether this relationship is moderated by functional connectivity. Methods For this single-arm repeated measures study, we recruited 25 PwMS for a 12-week program. Following magnetic resonance imaging, participants were tested using the Symbol Digit Modalities Test (SDMT) pre- and postrehabilitation. Baseline patterns of structural and functional connectivity were characterized relative to healthy controls. Results Lower white matter tract disruption in a network of region-pairs centered on the precuneus and posterior cingulate (default-mode network regions) predicted greater postrehabilitation SDMT improvement (P = .048). This relationship was moderated by profiles of functional connectivity within the network (R2 = .385, P = .017, Interaction β = -.415). Conclusion Patient response to restorative cognitive rehabilitation is predictable from the interaction between structural network disruption and functional connectivity in the default-mode network. This effect may be related to cognitive reserve.
- Published
- 2020
43. Supervised transcranial direct current stimulation (tDCS) at home: A guide for clinical research and practice
- Author
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Marom Bikson, Adam J. Woods, Leigh Charvet, Helena Knotkova, and Michael Shaw
- Subjects
Male ,medicine.medical_specialty ,Biomedical Research ,medicine.medical_treatment ,Biophysics ,tDCS safety guide ,Transcranial Direct Current Stimulation ,050105 experimental psychology ,lcsh:RC321-571 ,03 medical and health sciences ,0302 clinical medicine ,Physical medicine and rehabilitation ,Humans ,Medicine ,0501 psychology and cognitive sciences ,Non-invasive brain stimulation ,Electrodes ,lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry ,Best practices in tDCS ,Transcranial direct-current stimulation ,business.industry ,General Neuroscience ,05 social sciences ,Telemedicine ,Neuromodulation (medicine) ,Transcranial direct current stimulation (tDCS) ,At-home tDCS ,Clinical trial ,Clinical research ,Remotely supervised tDCS ,Research Design ,Practice Guidelines as Topic ,Patient Compliance ,Female ,Neurology (clinical) ,Nervous System Diseases ,business ,030217 neurology & neurosurgery - Abstract
Background Transcranial direct current stimulation (tDCS) is a method of noninvasive neuromodulation and potential therapeutic tool to improve functioning and relieve symptoms across a range of central and peripheral nervous system conditions. Evidence suggests that the effects of tDCS are cumulative with consecutive daily applications needed to achieve clinically meaningful effects. Therefore, there is growing interest in delivering tDCS away from the clinic or research facility, usually at home. Objective To provide a comprehensive guide to operationalize safe and responsible use of tDCS in home settings for both investigative and clinical use. Methods Providing treatment at home can improve access and compliance by decreasing the burden of time and travel for patients and their caregivers, as well as to reach those in remote locations and/or living with more advanced disabilities. Results To date, methodological approaches for at-home tDCS delivery have varied. After implementing the first basic guidelines for at-home tDCS in clinical trials, this work describes a comprehensive guide for facilitating safe and responsible use of tDCS in home settings enabling access for repeated administration over time. Conclusion These guidelines provide a reference and standard for practice when employing the use of tDCS outside of the clinic setting.
- Published
- 2020
44. Delivering Transcranial Direct Current Stimulation Away From Clinic: Remotely Supervised tDCS
- Author
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Giuseppina Pilloni, Michael Shaw, and Leigh Charvet
- Subjects
Adult ,Male ,Study groups ,medicine.medical_specialty ,Multiple Sclerosis ,medicine.medical_treatment ,Pilot Projects ,Transcranial Direct Current Stimulation ,03 medical and health sciences ,0302 clinical medicine ,Physical medicine and rehabilitation ,Outpatients ,Humans ,Medicine ,Aged ,Rehabilitation ,Transcranial direct-current stimulation ,business.industry ,Public Health, Environmental and Occupational Health ,Equipment Design ,General Medicine ,Service member ,Middle Aged ,Telemedicine ,Cognitive training ,030227 psychiatry ,Tolerability ,Female ,business ,030217 neurology & neurosurgery - Abstract
Introduction To demonstrate the broad utility of the remotely supervised transcranial direct current stimulation (RS-tDCS) protocol developed to deliver at-home rehabilitation for individuals with multiple sclerosis (MS). Methods Stimulation delivered with the RS-tDCS protocol and paired with adaptive cognitive training was delivered to three different study groups of MS patients to determine the feasibility and tolerability of the protocol. The three studies each used consecutively increasing amounts of stimulation amperage (1.5, 2.0, and 2.5 mA, respectively) and session numbers (10, 20, and 40 sessions, respectively). Results High feasibility and tolerability of the stimulation were observed for n = 99 participants across three tDCS pilot studies. Conclusions RS-tDCS is feasible and tolerable for MS participants. The RS-tDCS protocol can be used to reach those in locations without clinic access and be paired with training or rehabilitation in locations away from the clinic. This protocol could be used to deliver tDCS paired with training or rehabilitation activities remotely to service members and veterans.
- Published
- 2020
45. Cerebral metabolic rate of oxygen (CMRO2) changes measured with simultaneous tDCS-MRI in healthy adults
- Author
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Marco Muccio, Lillian Walton Masters, Giuseppina Pilloni, Peidong He, Lauren Krupp, Abhishek Datta, Marom Bikson, Leigh Charvet, and Yulin Ge
- Subjects
General Neuroscience ,Neurology (clinical) ,Molecular Biology ,Developmental Biology - Published
- 2022
46. Demographic and social determinants of cognitive dysfunction following hospitalization for COVID-19
- Author
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Eduard Valdes, Benjamin Fuchs, Chris Morrison, Leigh Charvet, Ariane Lewis, Sujata Thawani, Laura Balcer, Steven L. Galetta, Thomas Wisniewski, and Jennifer A. Frontera
- Subjects
Cognitive ,Post-acute sequelae of COVID ,SARS-CoV-2 ,Social Determinants of Health ,COVID-19 ,Long-COVID ,Article ,Brain fog ,Hospitalization ,Cognition ,Neurology ,Memory ,Long-hauler ,Humans ,Cognitive Dysfunction ,Dementia ,Prospective Studies ,Neurology (clinical) ,MOCA - Abstract
Background Persistent cognitive symptoms have been reported following COVID-19 hospitalization. We investigated the relationship between demographics, social determinants of health (SDOH) and cognitive outcomes 6-months after hospitalization for COVID-19. Methods We analyzed 6-month follow-up data collected from a multi-center, prospective study of hospitalized COVID-19 patients. Demographic and SDOH variables (age, race/ethnicity, education, employment, health insurance status, median income, primary language, living arrangements, and pre-COVID disability) were compared between patients with normal versus abnormal telephone Montreal Cognitive Assessments (t-MOCA; scores
- Published
- 2022
47. Response heterogeneity to home-based restorative cognitive rehabilitation in multiple sclerosis: An exploratory study
- Author
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Rebecca Campbell, Tom A. Fuchs, Jose Escobar, Michael Shaw, Alexander Bartnik, Jeta Pol, Michael G. Dwyer, Leigh Charvet, Robert Zivadinov, Chana Kolb, Curtis Wojcik, Bianca Weinstock-Guttman, David Hojnacki, Stefano Ziccardi, Devon Oship, Faizan Yasin, and Ralph H.B. Benedict
- Subjects
Male ,medicine.medical_specialty ,Multiple Sclerosis ,medicine.medical_treatment ,Therapeutics ,Neuropsychological Tests ,Neurological rehabilitation ,03 medical and health sciences ,Cognition ,0302 clinical medicine ,Physical medicine and rehabilitation ,Quality of life ,medicine ,Humans ,Cognitive Dysfunction ,Multiple sclerosis ,Telemedicine ,Brain ,Female ,Follow-Up Studies ,Magnetic Resonance Imaging ,Middle Aged ,Organ Size ,Patient Compliance ,Personality ,Quality of Life ,Treatment Outcome ,Cognitive Behavioral Therapy ,Self Care ,030212 general & internal medicine ,Cognitive rehabilitation therapy ,business.industry ,Neuropsychology ,Repeated measures design ,General Medicine ,Cognitive training ,Cognitive behavioral therapy ,Clinical trial ,Neurology ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Abstract
Growing evidence supports the efficacy of restorative cognitive training in people with multiple sclerosis (PwMS), but the effects vary across individuals. Differences in treatment efficacy may be related to baseline individual differences. We investigated clinical characteristics and MRI variables to predict response to a previously validated approach to home-based restorative cognitive training.In a single-arm repeated measures study, 51 PwMS completed a 12-week at-home restorative cognitive training program called BrainHQ, shown to be effective in a placebo-controlled clinical trial. Baseline demographic, clinical, neuropsychological, and brain MRI factors were captured and the effects of treatment were quantified with Symbol Digit Modalities Test (SDMT). Also measured were indices of treatment compliance. Regression modeling was employed to identify the factors associated with greatest SDMT improvement.As a group, patients improved significantly after training: mean SDMT improving from 49.6 ± 14.7 to 52.6 ± 15.6 (t = 3.91, p0.001). Greater SDMT improvement correlated positively with treatment exposure (r = 0.38, p = 0.007). Increased post-rehabilitation improvement on SDMT was predicted by baseline relapsing-remitting course (β=-0.34, p = 0.017), higher trait Conscientiousness-Orderliness (β=0.29, p = 0.040), and higher baseline gray matter volume (GMV; β=0.31, p = 0.030).The study was designed to explore the variables that predict favorable outcome in a home-based application of a validated restorative cognitive training program. We find good outcomes are most likely in patients with higher trait Conscientiousness-Orderliness, and relapsing-remitting course. The same was found for individuals with higher GMV. Future work in larger cohorts is needed to support these findings and to investigate the unique needs of individuals according to baseline factors.
- Published
- 2019
48. Long term at-home treatment with transcranial direct current stimulation (tDCS) improves symptoms of cerebellar ataxia: a case report
- Author
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Michael Shaw, Leigh Charvet, Abhishek Datta, Ashley Clayton, Charles Feinberg, Giuseppina Pilloni, and Maria Palmeri
- Subjects
Cerebellar tDCS ,030506 rehabilitation ,medicine.medical_specialty ,Neurology ,medicine.medical_treatment ,Health Informatics ,Timed Up and Go test ,Transcranial Direct Current Stimulation ,lcsh:RC321-571 ,03 medical and health sciences ,Physical medicine and rehabilitation ,Medicine ,Humans ,lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry ,Cerebellar ataxia ,Aged ,Telerehabilitation ,Transcranial direct-current stimulation ,business.industry ,Research ,Rehabilitation ,Motor control ,Gait ,Cognitive training ,Transcranial direct current stimulation (tDCS) ,Preferred walking speed ,Treatment Outcome ,Remotely supervised tDCS ,Female ,medicine.symptom ,0305 other medical science ,business - Abstract
Progressive cerebellar ataxia is a neurodegenerative disorder without effective treatment options that seriously hinders quality of life. Previously, transcranial direct current stimulation (tDCS) has been demonstrated to benefit cerebellar functions (including improved motor control, learning and emotional processing) in healthy individuals and patients with neurological disorders. While tDCS is an emerging therapy, multiple daily sessions are needed for optimal clinical benefit. This case study tests the symptomatic benefit of remotely supervised tDCS (RS-tDCS) for a patient with cerebellar ataxia. We report a case of a 71-year-old female patient with progressive cerebellar ataxia, who presented with unsteady gait and balance impairment, treated with tDCS. tDCS was administered using our RS-tDCS protocol and was completed daily in the patient’s home (Monday – Friday) with the help of a trained study technician. tDCS was paired with 20 min of simultaneous cognitive training, followed by 20 min of physical exercises directed by a physical therapist. Stimulation consisted of 20 min of 2.5 mA direct current targeting the cerebellum via an anodal electrode and a cathodal electrode placed over the right shoulder. The patient completed baseline and treatment end visits with neurological, cognitive, and motor (Lafayette Grooved Pegboard Test, 25 ft walk test and Timed Up and Go Test) assessments. The patient successfully completed sixty tDCS sessions, 59 of which were administered remotely at the patient’s home with the use of real time supervision as enabled by video conferencing. Mild improvement was observed in the patient’s gait with a 7% improvement in walking speed, which she completed without a walking-aid at treatment end, which was in stark contrast to her baseline assessment. Improvements were also achieved in manual dexterity, with an increase in pegboard scores bilaterally compared to baseline. Results from this case report suggest that consecutively administered tDCS treatments paired with cognitive and physical exercise hold promise for improving balance, gait, and manual dexterity in patients with progressive ataxia. Remotely supervised tDCS provides home access to enable the administration over an extended period. Further controlled study in a large group of those with cerebellar ataxia is needed to replicate these findings. ClinicalTrials.gov Identifier: NCT03049969 . Registered 10 February 2017- Retrospectively registered.
- Published
- 2019
49. Risk of COVID-19 infection and severe disease in MS patients on different disease-modifying therapies
- Author
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Tyler E Smith, Maya Madhavan, Daniel Gratch, Aneek Patel, Valerie Saha, Carrie Sammarco, Zoe Rimler, Guadalupe Zuniga, Dunia Gragui, Leigh Charvet, Gary Cutter, Lauren Krupp, Ilya Kister, and Lana Zhovtis Ryerson
- Subjects
Multiple Sclerosis ,Neurology ,SARS-CoV-2 ,Dimethyl Fumarate ,Natalizumab ,COVID-19 ,Humans ,Neurology (clinical) ,General Medicine ,Rituximab - Abstract
The risk of SARS-CoV-2 infection and severity with disease modifying therapies (DMTs) in multiple sclerosis (MS) remains unclear, with some studies demonstrating increased risks of infection with B-cell-depleting (anti-CD20) therapies and severity, while others fail to observe an association. Most existing studies are limited by a reliance on 'numerator' data (i.e., COVID-19 cases) only.To assess the risks of COVID-19 by DMT, this study aimed to assess both 'numerator' (patients with SARS-CoV-2 infection) and 'denominator' data (all patients treated with DMTs of interest) to determine if any DMTs impart an increased risk of SARS-CoV-2 infection or disease severity.We systematically reviewed charts and queried patients during clinic encounters in the NYU MS Comprehensive Care Center (MSCCC) for evidence of COVID-19 in all patients who were on the most commonly used DMTs in our clinic (sphingosine-1-phosphate receptor (S1P) modulators (fingolimod/siponimod), rituximab, ocrelizumab, fumarates (dimethyl fumarate/diroximel fumarate), and natalizumab). COVID-19 status was determined by clinical symptoms (CDC case definition) and laboratory testing where available (SARS-CoV-2 PCR, SARS-CoV-2 IgG). Multivariable analyses were conducted to determine predictors of infection and severe disease (hospitalization or death) using SARS-CoV-2 infected individuals per DMT group and all individuals on a given DMT as denominator.We identified 1,439 MS patients on DMTs of interest, of which 230 had lab-confirmed (n = 173; 75.2%) or suspected (n = 57; 24.8%) COVID-19. Infection was most frequent in those on rituximab (35/138; 25.4%), followed by fumarates (39/217; 18.0%), S1P modulators (43/250; 17.2%), natalizumab (36/245; 14.7%), and ocrelizumab (77/589; 13.1%). There were 14 hospitalizations and 2 deaths. No DMT was found to be significantly associated with increased risk of SARS-CoV-2 infection. Rituximab was a predictor of severe SARS-CoV-2 infection among patients with SARS-CoV-2 infection (OR 6.7; 95% CI 1.1-41.7) but did not reach statistical significance when the entire patient population on DMT was used (OR 2.8; 95% CI 0.6-12.2). No other DMT was associated with an increased risk of severe COVID-19.Analysis of COVID-19 risk among all patients on the commonly used DMTs did not demonstrate increased risk of infection with any DMT. Rituximab was associated with increased risk for severe disease.
- Published
- 2022
50. Remotely-supervised transcranial direct current stimulation paired with cognitive training in Parkinson’s disease: An open-label study
- Author
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Bryan Dobbs, Leigh Charvet, Alberto Cucca, Kush Sharma, Shashank Agarwal, Michael Shaw, Natalie Pawlak, and Milton C. Biagioni
- Subjects
Adult ,Male ,030506 rehabilitation ,medicine.medical_specialty ,Parkinson's disease ,medicine.medical_treatment ,Prefrontal Cortex ,Transcranial Direct Current Stimulation ,03 medical and health sciences ,Cognition ,0302 clinical medicine ,Physical medicine and rehabilitation ,Rating scale ,Physiology (medical) ,Humans ,Medicine ,Prospective Studies ,Aged ,Aged, 80 and over ,Cognitive Behavioral Therapy ,Transcranial direct-current stimulation ,business.industry ,Parkinson Disease ,General Medicine ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Gait ,Telemedicine ,Cognitive training ,Clinical trial ,Neurology ,Videoconferencing ,Female ,Surgery ,Neurology (clinical) ,0305 other medical science ,business ,030217 neurology & neurosurgery ,Grooved Pegboard Test - Abstract
Background Transcranial direct current stimulation (tDCS) has been explored as a potential intervention in Parkinson’s disease (PD) and recent studies have shown promising results in cognitive, gait and motor function. However, evidence of efficacy is limited due to small size studies, short treatment periods, lack of standardization of methodologies and other study design limitations. Remotely supervised-tDCS (RS-tDCS) allows “at-home” study participation, potentially easing recruitment, compliance and overall feasibility for clinical studies. Objective Here, we aim to explore preliminary effects of RS-tDCS paired with cognitive training in PD by delivering RS-tDCS neuromodulation at participant’s home while still maintaining clinical trial standards. Methods This was a prospective, open-label study using RS-tDCS paired with cognitive training. Each PD participant completed 10 tDCS sessions (20-min, 1.5–2.0-mA, bi-hemispheric DLPFC montage, left anodal), over a span of two weeks. All tDCS sessions were supervised in real-time through videoconferencing. Outcomes included the Unified Parkinson’s Disease Rating Scale (UPDRS) and Grooved Pegboard Test. Results All RS-tDCS sessions were well tolerated and completed successfully. Total UPDRS and motor UPDRS-III scores decreased significantly. Pegboard completion time improved significantly for the non-dominant hand. There was a strong positive correlation between the time of the sessions, and motor improvements in UPDRS part-III. Conclusion RS-tDCS paradigm through a ‘telemedicine protocol’ holds therapeutic potential for motor symptoms in PD while maximizing compliance and ease of recruitment. Conducting afternoon sessions might be more effective than during the morning. Our paradigm may be influential in designing future studies and facilitating larger and longer duration clinical trials.
- Published
- 2018
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