NeuroSigma, Inc., a Los Angeles-based bioelectronics company commercializing external trigeminal nerve stimulation (eTNS) technology for treating neurological and neuropsychiatric disorders, today announced that enrollment has commenced in two large, multicenter double-blind trials of eTNS for pediatric attention-deficit/hyperactivity disorder (ADHD).
The first trial, known as ADHD-GEMS and sponsored by the National Institutes of Mental Health (NIMH), is being conducted at UCLA and Seattle Children’s Hospital. Up to 225 children will be enrolled in a 4-week double-blinded phase followed by up to 1-year of open label follow-up.
The second trial, known as the ATTENS project, is sponsored by the UK’s National Institute for Health Research and is being conducted at King’s College London and the University of Southampton. This trial will enroll up 150 children and adolescents with ADHD for a 4-week blinded period and will obtain fMRI data in approximately 50 subjects to better understand the underlying eTNS mechanism of action.
“The start of enrollment in these two trials marks a major milestone for NeuroSigma and for advancing alternatives to medications to treat ADHD,” said Ian Cook, M.D., NeuroSigma’s Chief Medical Officer. “The data generated will significantly expand the evidence base for eTNS as a treatment for pediatric ADHD and, we believe, demonstrate the value of eTNS as a non-pharmaceutical alternative for treating this common condition. We are also excited to examine the fMRI neuroimaging data, which will enable us to demonstrate eTNS’ mechanism of action and the physiology of response.”
“We are proud to support our world-class academic sponsors during the conduct of these important clinical trials,” added Colin Kealey, M.D., President and Chief Executive Officer of NeuroSigma. “The trials will produce a robust data set encompassing both children and adolescents with ADHD, as well as use of the device as an adjunctive therapy for patients already on medication. We believe this will set the stage for expanding our label into the adolescent and adjunctive populations, thereby adding tremendous value to the company.”
For Patients and Caregivers Interested in the Trials
If you are interested in learning more about how you or your loved ones can participate in these trials, please visit the websites below: