The ATTENS (ADHD trial of external trigeminal nerve stimulation) project, a multicenter, double-blind, placebo-controlled randomized controlled trial, has completed enrollment, investigating the effect of NeuroSigma's Monarch eTNS System on ADHD symptoms in children and adolescents. The trial, led by Professor Katya Rubia at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London, enrolled 150 subjects aged 8 to 18 years.
Participants were randomized 1:1 to receive either active or sham eTNS therapy for four weeks. The trial's primary endpoint is the improvement in ADHD symptoms after treatment, as measured by the ADHD-RS-V scale. Data collection will include fMRI neuroimaging, clinical and cognitive testing, and autonomic nervous system function measurements. The final patient visit is scheduled for March 2025.
Addressing Unmet Needs in ADHD Treatment
Professor Rubia stated that the robust recruitment and retention rates reflect the public's interest in non-pharmaceutical ADHD treatments, highlighting an urgent unmet medical need. The study is funded by an Efficacy and Mechanism Evaluation grant from the United Kingdom’s National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC).
Significance of the ATTENS Trial
Colin Kealey, M.D., President and CEO of NeuroSigma, emphasized the ATTENS trial as the largest clinical trial of the Monarch eTNS System to date. He anticipates that the trial will significantly increase their clinical dataset and provide unprecedented insight into the therapy’s mechanism of action. NeuroSigma is partnering with King’s College London and the University of Southampton on this endeavor.
About the Monarch eTNS System
The Monarch eTNS System is the first non-drug treatment for pediatric ADHD cleared by the FDA. NeuroSigma is exploring pipeline indications for the Monarch eTNS System, including neurodevelopmental disorders such as autism spectrum disorder (ASD), learning disabilities, and epilepsy. The FDA has granted Breakthrough Device Designation for the Monarch eTNS System in drug-resistant epilepsy.
