NeuroSigma Funds First-Ever Pediatric Clinical Trial to Study Non-Invasive External Trigeminal Nerve Stimulation for the Treatment of ADHD
24 Oct, 2011, 07:00 ET
LOS ANGELES, Oct. 24, 2011 /PRNewswire/ -- 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.
eTNS™ is a non-invasive therapy. NeuroSigma's eTNS™ system utilizes a self-adhesive conductive pad applied to the forehead to stimulate branches of the trigeminal nerve, which are located very close to the surface of the skin above the forehead. The trigeminal nerve is one of the largest in the body, offering a high-bandwidth pathway for signals to enter the brain. In clinical studies, eTNS™ is well tolerated and the low-energy stimulus is confined to the soft tissues of the forehead without penetration into the brain.
CAUTION: The eTNS™ system is an investigational device and at this time is limited by United States law for investigational use only in approved research protocols. NeuroSigma does not recommend the off-label use of nerve or muscle electrical stimulation units for any purpose not approved by the FDA because of the potential risk of injury or death.
ADHD is a neurobehavioral disorder characterized by inattention and hyperactivity, and associated with difficulties in academic, family, and social settings. Onset is usually in childhood, and it affects over 5.4 million children between ages 4 and 17 in the United States (nearly 1 in 10 children). Symptoms include difficulties with paying attention, being easily distracted, disorganized work habits, forgetfulness in daily activities, fidgeting, restlessness, trouble taking turns, and making careless mistakes in school or other activities.
About NeuroSigma, Inc.
NeuroSigma is a Los Angeles-based medical technology company established to in-license and develop early stage technologies with the potential to transform medical practice. Currently we have a specific focus on neuromodulation and through our majority-owned subsidiary, NSVascular, on Thin-Film Nitinol covered stents for endovascular applications. NeuroSigma employs two therapy platforms: Trigeminal Nerve Stimulation (TNS) and Deep Brain Stimulation (DBS). NeuroSigma has amassed significant intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including potential therapies for epilepsy, depression, Attention Deficit Hyperactivity Disorder (ADHD) and post-traumatic stress disorder (PTSD) via TNS and for PTSD, obesity and cachexia via DBS. For more information about NeuroSigma, visit our website at http://www.neurosigma.com.
SOURCE NeuroSigma, Inc.
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