NeuroSigma has announced that the US National Institutes of Health (NIH) has awarded UCLA a grant that funds a phase II 90-subject paediatric clinical trial at the University of California, Los Angeles (UCLA) focused on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) with NeuroSigma’s Monarch external trigeminal nerve stimulation (eTNS) system.
James McGough, professor of Psychiatry and Biobehavioral Sciences at UCLA, will lead the study as principal investigator, with Sandra Loo, associate professor, as co-principal investigator. Their earlier phase I trial of eTNS for the treatment of ADHD, funded by NeuroSigma, found significant improvements in the severity of ADHD symptoms with eight weeks of nightly eTNS therapy. This phase II clinical trial will evaluate eTNS as monotherapy, under double-blind conditions, in up to 90 children, ages eight to 12, in a four week randomised clinical trial conducted at UCLA. NeuroSigma will provide eTNS systems to UCLA in support of the trial. Neither McGough nor Loo has any affiliation with NeuroSigma.
ADHD usually arises in childhood. The US Center for Disease Control and Prevention (CDC) has reported national survey findings that approximately 11% of children ages four to 17 have been diagnosed with the disorder, and that about one in five high school boys will receive this diagnosis during childhood. Symptoms include difficulty paying attention in school, at play, or in the home, a reluctance to take on tasks that require sustained mental effort, being easily distracted, exhibiting physical hyperactivity, and engaging in impulsive behaviours. These symptoms may interfere with social, school, or work functioning.
“I am very pleased that the NIH has funded this extremely important phase II clinical trial in ADHD. Millions of parents seek alternatives to drug treatment for their children with ADHD that are safe and non-invasive,” says Leon Ekchian, NeuroSigma’s president and chief executive officer.
“McGough and Loo are to be congratulated for receiving this grant, particularly at a time when the NIH budget is under pressure to fund only the most promising lines of investigation. NIH awards represent one of the most stringent forms of peer review in biomedical science,” notes Ian Cook, NeuroSigma’s chief medical officer and senior vice president. “Besides showing safety of eTNS in children, their phase I study found a significant impact on the clinical symptoms of ADHD, and substantial improvements on sleep as well as several objective computer-based measures of cognitive performance. We look forward to confirming these results in this phase II clinical trial under double-blind controlled conditions. A neuromodulation treatment option for ADHD could avoid concerns about the exposure of children to the psychostimulant medications that are the current first-line treatments.”