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Automation is revamping our preprocessing pipelines, and accelerating the delivery of personalized digital medicine. It improves efficiency, reduces costs, and allows clinicians to treat patients without significant delays. However, the influx of multimodal data highlights the need to protect sensitive information, such as clinical data, and safeguard data fidelity. One of the neuroimaging modalities that produces large amounts of time-series data is Electroencephalography (EEG). It captures the neural dynamics in a task or resting brain state with high temporal resolution. EEG electrodes placed on the scalp acquire electrical activity from the brain. These electrical potentials attenuate as they cross multiple layers of brain tissue and fluid yielding relatively weaker signals than noise-low signal-to-noise ratio. EEG signals are further distorted by internal physiological artifacts, such as eye movements (EOG) or heartbeat (ECG), and external noise, such as line noise (50 Hz). EOG artifacts, due to their proximity to the frontal brain regions, are particularly challenging to eliminate. Therefore, a widely used EOG rejection method, independent component analysis (ICA), demands manual inspection of the marked EOG components before they are rejected from the EEG data. We underscore the inaccuracy of automatized ICA rejection and provide an auxiliary algorithm-Second Layer Inspection for EOG (SLOG) in the clinical environment. SLOG based on spatial and temporal patterns of eye movements, re-examines the already marked EOG artifacts and confirms no EEG-related activity is mistakenly eliminated in this artifact rejection step. SLOG achieved a 99% precision rate on the simulated dataset while 85% precision on the real EEG dataset. One of the primary considerations for cloud-based applications is operational costs, including computing power. Algorithms like SLOG allow us to maintain data fidelity and precision without overloading the cloud platforms and maxing out our budgets., (Creative Commons Attribution license.)

A significant amount of European basic and clinical neuroscience research includes the use of transcranial magnetic stimulation (TMS) and low intensity transcranial electrical stimulation (tES), mainly transcranial direct current stimulation (tDCS). Two recent changes in the EU regulations, the introduction of the Medical Device Regulation (MDR) (2017/745) and the Annex XVI have caused significant problems and confusions in the brain stimulation field. The negative consequences of the MDR for non-invasive brain stimulation (NIBS) have been largely overlooked and until today, have not been consequently addressed by National Competent Authorities, local ethical committees, politicians and by the scientific communities. In addition, a rushed bureaucratic decision led to seemingly wrong classification of NIBS products without an intended medical purpose into the same risk group III as invasive stimulators. Overregulation is detrimental for any research and for future developments, therefore researchers, clinicians, industry, patient representatives and an ethicist were invited to contribute to this document with the aim of starting a constructive dialogue and enacting positive changes in the regulatory environment., (Copyright © 2024 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.)

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., (Copyright © 2022 International Federation of Clinical Neurophysiology. All rights reserved.)

Deep brain stimulation (DBS) provides clinical benefits for several neurological and psychiatric conditions. By overcoming the limitations and risks of conventional DBS, transcranial temporal interference stimulation (tTIS) has the potential to offer non-invasive stimulation of deep brain regions. However, research that investigates the efficacy of tTIS is limited to animal studies or computer simulations and its capability to modulate neural oscillations in humans has not been demonstrated so far. The method of tTIS is hypothesized to elicit its effects via neural entrainment, corresponding to the supposed mechanism of action underlying transcranial alternating current stimulation (tACS), another, more established non-invasive brain stimulation technique. Physiological effects of tACS are well established for cortical brain oscillations, but not for deep brain structures. In particular, aftereffects on the power of parieto-occipital alpha oscillations have been shown repeatedly. In a first attempt to test the efficacy of tTIS in the human brain, the current study thus seeks to compare the effects of tTIS to the well-studied aftereffect of tACS in the cortex. To investigate this research question, the current study compared MEG-recorded brain activity during a simple visual change detection task in 34 healthy subjects pre- and post-tTIS. Additionally, the effects of tTIS were contrasted to conventional tACS and a control stimulation. We expected that the parieto-occipital α-power will increase after tTIS and tACS, in contrast to the control stimulation. Overall, no difference between the experimental groups (tTIS, tACS and control stimulation) were found regarding the source-projected increase in α-power. Based on the results of the study two hypothesis can be made: tTIS, tACS and the control stimulation condition don't have an effect on human brain oscillations in the α-band, or, any experimental conditions of the current study can modulate brain oscillations in the α-band. Both hypotheses emphasize the importance of further studies investigating different carrier frequencies, and the comparison to sham stimulation., Competing Interests: Declaration of competing interest CSH holds a patent on brain stimulation. KS is the manufacturer of the advanced DC stimulator plus (Neuroconn, Ilmenau, Germany). JC, FHK, BCB and AA declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Low-intensity transcranial electrical stimulation (tES), including alternating or direct current stimulation, applies weak electrical stimulation to modulate the activity of brain circuits. Integration of tES with concurrent functional MRI (fMRI) allows for the mapping of neural activity during neuromodulation, supporting causal studies of both brain function and tES effects. Methodological aspects of tES-fMRI studies underpin the results, and reporting them in appropriate detail is required for reproducibility and interpretability. Despite the growing number of published reports, there are no consensus-based checklists for disclosing methodological details of concurrent tES-fMRI studies. The objective of this work was to develop a consensus-based checklist of reporting standards for concurrent tES-fMRI studies to support methodological rigor, transparency and reproducibility (ContES checklist). A two-phase Delphi consensus process was conducted by a steering committee (SC) of 13 members and 49 expert panelists through the International Network of the tES-fMRI Consortium. The process began with a circulation of a preliminary checklist of essential items and additional recommendations, developed by the SC on the basis of a systematic review of 57 concurrent tES-fMRI studies. Contributors were then invited to suggest revisions or additions to the initial checklist. After the revision phase, contributors rated the importance of the 17 essential items and 42 additional recommendations in the final checklist. The state of methodological transparency within the 57 reviewed concurrent tES-fMRI studies was then assessed by using the checklist. Experts refined the checklist through the revision and rating phases, leading to a checklist with three categories of essential items and additional recommendations: (i) technological factors, (ii) safety and noise tests and (iii) methodological factors. The level of reporting of checklist items varied among the 57 concurrent tES-fMRI papers, ranging from 24% to 76%. On average, 53% of checklist items were reported in a given article. In conclusion, use of the ContES checklist is expected to enhance the methodological reporting quality of future concurrent tES-fMRI studies and increase methodological transparency and reproducibility., (© 2022. © The Author(s).)

Background: Advances in transcranial electrical stimulation (tES) are hampered by the conventional rubber electrodes manually attached to the head with rubber bands. This procedure limits montages to a few electrodes, is error prone with respect to electrode configurations and is burdensome for participants and operators. A newly developed flexible cap with integrated textile stimulation electrodes was compared to the conventional setup of rubber electrodes inserted into sponges fixated by rubber bands, with respect to usability and reliability. Two operators applied both setups to 20 healthy volunteers participating in the study. Electrode position and impedance measures as well as subjective evaluations from participants and operators were obtained throughout the stimulation sessions., Results: Our results demonstrated the superiority of the flexible cap by means of significantly higher electrode configuration reproducibility and a more efficient application. Both, operators and volunteers evaluated the flexible cap as easier to use and more comfortable to wear when compared to the conventional setup., Conclusion: In conclusion, the new cap improves existing and opens new application scenarios for tES.

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique increasingly used to modulate neural activity in the living brain. In order to establish the neurophysiological, cognitive or clinical effects of tDCS, most studies compare the effects of active tDCS to those observed with a sham tDCS intervention. In most cases, sham tDCS consists in delivering an active stimulation for a few seconds to mimic the sensations observed with active tDCS and keep participants blind to the intervention. However, to date, sham-controlled tDCS studies yield inconsistent results, which might arise in part from sham inconsistencies. Indeed, a multiplicity of sham stimulation protocols is being used in the tDCS research field and might have different biological effects beyond the intended transient sensations. Here, we seek to enlighten the scientific community to this possible confounding factor in order to increase reproducibility of neurophysiological, cognitive and clinical tDCS studies., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Neuromodulation induced by transcranial electric stimulation (TES) exhibited promising potential for clinical practice. However, the underlying mechanisms remain subject of research. The combination of TES and electroencephalography (EEG) offers great potential for investigating these mechanisms and brain function in general, especially when performed simultaneously. In conventional applications, the combination of EEG and TES suffers from limitations on the electrode level (gel for electrode-skin interface) and the usability level (preparation time, reproducibility of positioning). To overcome these limitations, we designed a bifunctional cap for simultaneous TES-EEG applications. We used novel electrode materials, namely textile stimulation electrodes and dry EEG electrodes integrated in a flexible textile cap. We verified the functionality of this cap by analysing the effect of TES on visual evoked potentials (VEPs). In accordance with previous reports using standard TES, the amplitude of the N75 component was significantly decreased post-stimulation, indicating the feasibility of using this novel flexible cap for simultaneous TES and EEG. Further, we found a significant reduction of the P100 component only during TES, indicating a different brain modulation effect during and after TES. In conclusion, the novel bifunctional cap offers a novel tool for simultaneous TES-EEG applications in clinical research, therapy monitoring and closed-loop stimulation.

Impulsiveness in personality disordered forensic patients is associated with poor treatment completion and high risk of re-offending. A biofeedback training protocol, previously found to reduce impulsiveness and improve attention in children with Attention Deficit Hyperactivity Disorder, was used in an initial attempt to reduce impulsiveness in a severely personality disordered man with borderline, antisocial and histrionic features. Electrocortical, behavioural and self-report measures of impulsiveness were taken before and immediately following 6 weeks of biofeedback training and at 3 months follow-up. The patient successfully engaged with the intervention. His self-reports of reduced impulsiveness and improved attention were corroborated by behavioural and electrocortical measures that indicated reduced impulsiveness and better focused attention. Results suggest this intervention might prove useful in improving behavioural and emotional self-regulation in severely personality disordered patients., (Copyright © 2013 John Wiley & Sons, Ltd.)