NeuroSigma, Inc., a Los Angeles-based medical technology company, announced today that it has signed a contract with the University of California, Los Angeles (UCLA) to fund a Phase I pediatric clinical trial to study the use of non-invasive, external Trigeminal Nerve Stimulation (TNS) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). NeuroSigma is the exclusive worldwide licensee of UCLA's TNS intellectual property.
This study will be an open-label clinical trial of external TNS (eTNS™) therapy in 10 subjects with ADHD. The study will enroll boys and girls between 9 and 14 years of age, marking the first study in which children may enroll in a TNS trial.
The principal investigator for this Phase I eTNS™ ADHD study is James McGough, M.D., M.S., Professor of Clinical Psychiatry at the Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA. Dr. McGough also serves as director of clinical teaching programs in both Child and Adolescent Psychopharmacology and ADHD at UCLA.
"Intriguing findings from PET scan and clinical data in adults encouraged us to undertake this study of a promising alternative to medications and behavioral therapy," said Dr. McGough, who has contributed to the field's understanding of ADHD's causes and treatments for nearly two decades.
"I'm excited that this new approach to neuromodulation may be able to have an impact on a broad range of neuropsychiatric disorders," said Ian Cook, M.D., one of the inventors of TNS and Director of the UCLA Depression Research & Clinic Program, where initial studies of TNS in depression and PTSD were started. Dr. Cook is also an advisor to NeuroSigma.
"This study is an important step forward in potentially broadening the clinical indications for TNS. We are very pleased to be working with Dr. McGough who is widely regarded as a leader in ADHD research," said NeuroSigma's Chairman Lodwrick Cook. "It is our hope that our non-invasive eTNS™ therapy may ultimately be proven to aid in the treatment of children with ADHD without the side effects associated with other current therapies such as prescription medication," added Leon Ekchian, Ph.D., President and CEO of NeuroSigma.
NeuroSigma expects that the trial will commence in November 2011. Parents who live near Los Angeles and wish to learn more about enrolling a child after November 1st may visit www.adhd-la.com/ for details and contact information.