The Center for Evidence-Based Psychiatry (CEBP) in Denmark has approved the commencement of a clinical trial for NeuroSigma’s Monarch® eTNS System, targeting pediatric attention-deficit hyperactivity disorder (ADHD). This trial, led by Professor Ole Jakob Storebø, will be conducted across several Danish child and adolescent psychiatry centers. It is supported by funding from the Danish government, Region Zealand's Health Sciences Research Foundation, Region Southern Denmark Research Foundation, AP Møller, and the Jascha Foundation.
The clinical trial is structured into two phases. The initial phase will enroll up to 60 subjects aged 7 to 17 with ADHD across four Danish sites. These participants will receive either active or sham eTNS treatment over four weeks. The primary goal of this phase is to evaluate the feasibility of eTNS as an ADHD treatment, with a focus on changes in core ADHD symptoms between the active and sham groups. Secondary objectives include assessing cognitive function, autonomic nervous system function, sleep quality, and overall symptom severity. If the first phase proves successful, a larger trial involving 200 additional subjects will follow. Enrollment for the first phase is scheduled to start in December 2024.
Professor Storebø expressed enthusiasm about the trial, highlighting its significance in extending the age range for eTNS treatment and including patients who will use the device alongside stimulant medications. Colin Kealey, M.D., President and CEO of NeuroSigma, also emphasized the importance of this trial in advancing the ADHD treatment landscape by integrating the Monarch eTNS System with traditional pharmaceutical therapies. The findings from this trial are expected to complement ongoing research at King’s College London and the University of California, Los Angeles, contributing valuable data on the safety and efficacy of eTNS for ADHD.
NeuroSigma, based in Los Angeles, California, is at the forefront of developing bioelectronic medical devices aimed at transforming medical practices and improving patient lives. The Monarch eTNS System, their flagship product, represents the first non-drug treatment for pediatric ADHD approved by the FDA. The company is also exploring the system's potential in treating other neurodevelopmental disorders, such as autism spectrum disorder (ASD), learning disabilities, and epilepsy.
The CEBP, located in Region Zealand, Denmark, is dedicated to enhancing evidence-based practices in psychiatry. Its efforts include conducting reviews, supporting clinical trials, developing guidelines, and providing education to ensure high-quality mental health interventions.
