NeuroSigma, Inc. Release: Results of Pediatric Clinical Trial of External Trigeminal Nerve Stimulation for the Treatment of ADHD
Published: Apr 18, 2013
LOS ANGELES, April 18, 2013 /PRNewswire/ -- NeuroSigma, Inc., a California-based medical device company, today announced that the results of the first-ever pediatric clinical trial of external Trigeminal Nerve stimulation (eTNS) for the treatment of attention-deficit hyperactivity disorder (ADHD) will be presented at the American Psychiatric Association annual meeting in San Francisco on May 20, 2013. The clinical trial was conducted at the University of California, Los Angeles (UCLA) with funding provided by NeuroSigma.
This study, which began in November 2011, was a Phase I open-label trial of children ages 7 to 14 who had a DSM IV diagnosis of ADHD. Subjects received eTNS nightly as monotherapy for the 8-week study period. ADHD symptom severity and cognitive performance were assessed at baseline, four weeks and eight weeks. The a priori outcome metric was the investigator-completed ADHD rating scale (ADHD-RS scale).
The results will be presented by James McGough, M.D., M.S., principal investigator for the study and Professor of Clinical Psychiatry at the Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, and director of clinical teaching programs in both Child and Adolescent Psychopharmacology and ADHD at UCLA. Dr. McGough is a leading researcher in the field and has worked to understand ADHD's causes and develop new treatments for nearly two decades.
"PET scan data that showed the immediate effects of eTNS on activity in centers in the brain associated with attention prompted our interest in exploring eTNS as a treatment for ADHD in children," said Dr. McGough. "There is a pressing need for non-stimulant options to manage ADHD given parental and patient preferences to avoid medication use as well as the possible side effects of these drug therapies."
"The results of this study are eagerly awaited by the treatment community, especially by pediatricians, child psychologists and child psychiatrists who not only see severe side effects from current drug therapies but also worry about the significant risks for diversion and abuse of these drugs," said Ian Cook, M.D., Director of the UCLA Depression Research & Clinic Program, where initial studies of eTNS began in psychiatric conditions. Dr. Cook is also one of the inventors of eTNS and a Senior Scientific Advisor to NeuroSigma.
Background - TNS
The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain. The trigeminal nerve projects to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus and the cerebral cortex, which are involved in epilepsy, depression, PTSD, ADHD and other disorders.
Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, which are located very close to the surface of the skin in the forehead. The low-energy stimulus is confined to the soft tissues of the forehead without direct penetration into the brain. PET imaging studies in humans confirm that eTNS activates or inhibits key regions implicated in these disorders and the changes were observed within minutes of therapy.
NeuroSigma is the exclusive worldwide licensee of UCLA's entire TNS intellectual property portfolio and continues to develop additional technologies and target additional indications.
CAUTION: In the United States, both eTNS and sTNS are investigational devices and are limited by Federal (or United States) law to investigational use.
eTNS, sTNS, Monarch, and the Monarch eTNSare trademarks of NeuroSigma, Inc.
About NeuroSigma, Inc.
NeuroSigma is a Los Angeles-based medical device company established to develop early stage technologies with the potential to transform medical practice and patients' lives. Currently, NeuroSigma is focused on neuromodulation therapies and has amassed significant intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including TNS therapies for epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD). For more information about NeuroSigma, please visit www.neurosigma.com.
NeuroSigma's first TNS product, the Monarch eTNS System, is currently being marketed to patients in the European Union (EU), with a physician's prescription. In September 2012, NeuroSigma received CE Mark approval for the adjunctive treatment of epilepsy and major depressive disorder, for adults and children 9 years and older in the EU. The Monarch was recently unveiled in London at the 10th European Congress on Epileptology. The Monarch eTNS System consists of a small stimulator that can be placed in a pocket or worn at the waist, and an electric patch that is placed on the forehead. The patch stimulates the trigeminal nerve through the surface of the skin, and is used primarily while the patient is asleep.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements, including but not limited to, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding our eTNS and sTNS systems. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.
SOURCE NeuroSigma, Inc.