NeuroSigma, Inc. announced a new clinical trial for its Monarch external Trigeminal Nerve Stimulation (eTNS) device. The trial will investigate the device’s efficacy in treating ADHD symptoms in children with Fetal Alcohol Syndrome (FAS), led by Professor Joseph O’Neill at UCLA and funded by a $350,000 grant from the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The initial phase will involve up to 30 children aged 8-12, focusing on feasibility and tracking symptom changes, sleep habits, and adverse events.
This trial addresses a significant unmet need. Children with FAS often exhibit ADHD-like symptoms but respond poorly to traditional stimulant medications. A successful trial could provide a much-needed alternative therapy, improving outcomes for these vulnerable children and potentially reducing the long-term societal costs associated with untreated FASD. This research could also expand our understanding of the neurological mechanisms underlying both FASD and ADHD, leading to more refined diagnostic and treatment strategies.
The initial phase of the trial will primarily assess the feasibility of using the Monarch eTNS device in this population. If this phase proves successful, researchers will proceed to a larger, double-blind randomized crossover trial to rigorously evaluate the device’s efficacy. NeuroSigma provided the devices and supplies for the study. The NIAAA provided the initial funding.
A positive outcome from this trial could significantly expand the market for NeuroSigma’s Monarch eTNS device. It could also establish eTNS as a viable treatment option for a range of neurodevelopmental disorders, paving the way for further research and development in this emerging field. Furthermore, it would represent a critical step forward in addressing the complex challenges faced by children with FASD and their families.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
