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Bipolar disorder (BD) is a debilitating psychiatric disorder characterized by mood disturbances and executive function deficits. Impairments in executive function, including impulsivity, significantly impact the daily lives of individuals with BD. Transcranial photobiomodulation (t-PBM) with near-infrared light offers a promising noninvasive neurostimulation approach to improve cognitive function. The Transcranial Photobiomodulation for Executive Function in Bipolar Disorder (TPEB) study aims to explore the potential of t-PBM in individuals with BD and executive function impairments. This study will include 20 adults with BD who will each receive one sham and one t-PBM session on the first day of stimulation (treatment day 1), followed by one daily t-PBM stimulation session for four days (treatment days 2 to 5). Cerebral blood flow changes will be evaluated using functional magnetic resonance imaging. Impulsivity, decision-making, and reward responsiveness will be assessed using the Barratt Impulsiveness Scale, the Iowa Gambling Task, and a gambling task that evaluates reward. The outcomes involve examining changes in cerebral blood flow, improvements in decision-making, and reductions in impulsivity and manic symptoms. The TPEB study aims to provide valuable insights into the potential of t-PBM as a therapeutic intervention to enhance executive function in BD. [ABSTRACT FROM AUTHOR]

Down syndrome (DS) is the leading genetic cause of intellectual disability globally, affecting about 1 in every 800 births. Individuals with DS often face various neuropsychiatric conditions alongside intellectual disabilities due to altered brain development. Despite the diverse phenotypic expressions of DS, typical physical characteristics frequently influence language development and acquisition. EEG studies have identified abnormal oscillatory patterns in individuals with DS. Emerging interventions targeting the enhancement of gamma (40 Hz) neuronal oscillations show potential for improving brain electrical activity and cognitive functions in this population. However, effective cognitive interventions for DS remain scarce. Extensive research indicates that transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light can penetrate deeply into the cerebral cortex, modulate cortical excitability, and enhance cerebral perfusion and oxygenation. Furthermore, t-PBM has been shown to improve cognitive functions such as language, attention, inhibition, learning, and memory, including working memory. This study presents the rationale and design of an ongoing randomized, sham-controlled clinical trial aimed at assessing the effectiveness of t-PBM using NIR light in enhancing the language abilities of individuals with DS. [ABSTRACT FROM AUTHOR]

We report on the rationale and design of an ongoing National Institute of Mental Health (NIMH) sponsored R61-R33 project in major depressive disorder (MDD). Current treatments for MDD have significant limitations in efficacy and side effect burden. There is a critical need for device-based treatments in MDD that are efficacious, well-tolerated, and easy to use. This project focuses on the adjunctive use of the transcranial photobiomodulation (tPBM) with near-infrared (NIR) light for the treatment of MDD. tPBM with NIR light penetrates robustly into the cerebral cortex, stimulating the mitochondrial respiratory chain, and also significantly increases cerebral blood flow (CBF). In the R61 phase, we will conduct target engagement studies to demonstrate dose-dependent effects of tPBM on the prefrontal cortex (PFC) CBF, using the increase in fMRI blood-oxygenation-level-dependent (BOLD) signal levels as our Go/No-go target engagement biomarker. In the R33 phase, we will conduct a randomized clinical trial of tPBM vs. sham in MDD to establish the target engagement and evaluate the association between changes in the biomarker (BOLD signal) and changes in clinical symptoms, while also collecting important information on antidepressant effects, safety, and tolerability. The study will be done in parallel at New York University/the Nathan Kline Institute (NYU/NKI) and at Massachusetts General Hospital (MGH). The importance of this study is threefold: 1. it targets MDD, a leading cause of disability worldwide, which lacks adequate treatments; 2. it evaluates tPBM, which has a well-established safety profile and has the potential to be safe in at-home administration; and 3. it uses fMRI BOLD changes as a target engagement biomarker. If effects are confirmed, the present study will both support short-term clinical development of an easy to scale device for the treatment of MDD, while also validating a biomarker for the development of future, novel modulation strategies. [ABSTRACT FROM AUTHOR]