Double-blind randomized controlled trial will enroll up to 225 children at UCLA and Seattle Children’s Hospital
NeuroSigma will provide Monarch eTNS Systems and funding for long-term follow-up
LOS ANGELES, June 14, 2022 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a bioelectronic medical device company, today announced that a team at the University of California, Los Angeles (UCLA) led by Professor Sandra Loo received a National Institutes of Health (NIH) grant to conduct a double-blind randomized controlled trial of eTNS for pediatric attention-deficit/hyperactivity disorder (ADHD). The trial will enroll up to 225 children with moderate to severe ADHD at UCLA and Seattle Children’s Hospital for a blinded period of 4 weeks followed by an open label follow-up period of up to 1 year. Professor James McGough will be the Co-Lead at UCLA and Professor Mark Stein will lead the team at Seattle Children’s Hospital.
“We would like to thank Professor Loo and her team at UCLA as well as Professor Stein and his colleagues at Seattle Children’s for their successful efforts to obtain NIH funding for this important project,” said Dr. Colin Kealey, President of NeuroSigma. “With this study and the recently-announced clinical trial of eTNS for pediatric ADHD at King’s College London, NeuroSigma continues to execute on its strategy of working with leading academic centers to build out a world-class dataset supporting the clinical use of eTNS for pediatric ADHD.”
Building on earlier work at UCLA, this trial is designed to demonstrate the safety and efficacy of eTNS in a larger trial and validate certain hypotheses about the therapy’s mechanism of action, including the possibility of predicting responders with cognitive and EEG tests prior to initiating therapy. Funding for the 4-week blinded period is provided by NIH Grant 1R01MH126041-01A1 with devices and funding for the long-term open label period provided by NeuroSigma.
“We look forward to starting enrollment for this trial in the next few months,” commented Professor Loo. “There is a clear need for non-pharmacologic treatment options in pediatric ADHD. If successful, this trial will confirm the safety and efficacy of eTNS in this patient population, provide further validation of neural mechanisms of action, and provide clinicians with screening tools to predict which patients are good candidates for the therapy.”
More information about the study can be found at the following website: https://www.semel.ucla.edu/adhdandmood
NeuroSigma is a Los Angeles, California-based bioelectronic medical device company developing technologies to transform medical practice and patients' lives. The company is developing therapies to treat a wide spectrum of neurological and neuropsychiatric disorders, including ADHD, drug-resistant epilepsy, and depression. The company is currently commercializing the Monarch eTNS System, which is the first non-drug treatment for pediatric ADHD cleared by the FDA. For more information about NeuroSigma, please visit www.neurosigma.com. For more information on the Monarch eTNS System, please visit www.monarch-etns.com.
About the Grant
This project, titled Efficacy of External Trigeminal Nerve Stimulation for Treatment of ADHD (NIH Grant Number 1R01MH126041), is funded by a NIH/NIMH (National Institutes of Health/National Institute of Mental Health) grant awarded to Principal Investigator, Dr. Sandra Loo, Associate Professor in the UCLA Department of Psychiatry and Biobehavioral Sciences. Her Co-Principal Investigators on the project include Dr. James McGough, Professor of Clinical Psychiatry at the Semel Institute for Neuroscience and Human Behavior, and Dr. Mark Stein, Professor of Psychiatry and Behavioral Sciences at the University of Washington in Seattle. For more information, please visit the grant’s NIH RePorter page.
CONTACT: Colin Kealey, M.D., President of NeuroSigma at CKealey@neurosigma.com