LOS ANGELES, Jan. 5, 2015 /PRNewswire/ -- NeuroSigma®, Inc. (NeuroSigma) today announced that enrollment has commenced for a 90-subject Phase II pediatric clinical trial of its external trigeminal nerve stimulation (eTNS) technology as treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). The trial is being conducted at the Semel Institute for Neuroscience and Human Behavior, located at the University of California, Los Angeles (UCLA).
The trial is led by James McGough, M.D., M.S., Professor of Clinical Psychiatry as Principal Investigator and Sandra Loo, Ph.D., Associate Professor, as Co-Principal Investigator, both with the David Geffen School of Medicine at UCLA and the Semel Institute. Neither Dr. McGough nor Dr. Loo has an affiliation with NeuroSigma. The U.S. National Institute of Mental Health (NIMH) has provided grant funding to support this double-blind controlled trial of eTNS in children with ADHD, ages 8 to 12. NeuroSigma will be providing eTNS systems for the trial. Children will use the eTNS therapy each night at home as an alternative to the use of psychostimulant medications.
In an earlier Phase I clinical trial in children, with funding and eTNS systems provided by NeuroSigma, Dr. McGough and his team found significant improvements in the symptoms of ADHD as well as in cognition. A report of the Phase I trial is now published online in the journal Brain Stimulation summarizing the results on 24 youth, ages seven to fourteen, who had enrolled in an eight-week open trial of eTNS administered nightly during sleep. Significant improvements were seen on the ADHD-IV Rating Scale (P < 0.0001) and the parent-completed Conners Global Index (P < 0.0001). Improvements were also noted on computerized tests of cognition. The results of the Phase I trial serve as the scientific basis for this Phase II trial.
Enrollment in this new trial is now open to children with ADHD who are not taking medication to treat their condition. Parents or guardians can contact the UCLA ADHD Research Program at 310-267-4798 or online at www.semel.ucla.edu/adhdandmood.
"ADHD is estimated to affect up to 9.5% of school age children and 4.4% of adults, and our current treatments primarily include psychostimulant medications and behavioral therapies. While there is great demand for non-medication approaches to ADHD, most popular alternatives are not linked to any mechanistic understanding of brain processes and similarly lack significant scientific evidence to support their use. I am excited to have found a significant improvement in ADHD symptoms in our open trial of this neuromodulation treatment, and am eager to start the next step of investigating eTNS as an intervention for ADHD with this controlled clinical trial," said Dr. McGough. "In our past work, TNS was well accepted by patients and families, treatment compliance was high, sleep was improved, and there were no clinically meaningful side effects or adverse events."
"We congratulate Dr. McGough and his team for receiving NIMH funding for this important clinical trial of eTNS in ADHD. Patients and their families are seeking alternatives to psychostimulant medications, and additional clinical trials will help evaluate the role that eTNS may be able to play as a non-invasive, non-stimulant treatment. PET imaging data demonstrate that eTNS modifies the activity of identifiable brain circuits. These changes could be the mechanism by which eTNS may exert positive effects on attention, mood and sleep quality. In addition to looking at ADHD symptom improvement, Dr. McGough's new trial will gather data on mechanism of action in alignment with the NIMH's Research Domain Criteria or 'RDoC' program," said Ian Cook, M.D., Chief Medical Officer at NeuroSigma.
NeuroSigma is a California-based life sciences company focused on commercialization of its non-invasive eTNS technology for the treatment of neurological and neuropsychiatric disorders. NeuroSigma's Monarch eTNS system is currently approved in the European Union for the adjunctive treatment of major depressive disorder and in Canada for treatment of major depressive disorder, in each case for adults and children nine years and older. In the United States, the Monarch eTNS system is an investigational device and is limited by Federal law to investigational use.
Background – TNS
The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain, bilaterally and at high frequency. The trigeminal nerve projects directly or indirectly 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, post-traumatic stress disorder (PTSD), attention-deficit hyperactivity disorder (ADHD), traumatic brain injury (TBI), and other disorders.
Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, including those located near the surface of the forehead. Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.
CAUTION: In the United States, the eTNS and sTNS systems are investigational devices and are limited by Federal law to investigational use. The U.S. Food and Drug Administration (FDA) has given NeuroSigma approval to proceed with a pivotal Phase III clinical trial of external TNS (eTNS) in drug-resistant epilepsy. Completion of that Phase III trial is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.
eTNS, sTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.
About NeuroSigma, Inc.
NeuroSigma is a California-based life sciences company established to develop bioelectronic technologies with the potential to transform medical practice and patients' lives. NeuroSigma is focused on TNS neuromodulation therapies based on intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including TNS therapies for epilepsy, depression, PTSD, ADHD, and TBI. For more information about NeuroSigma, please visit www.neurosigma.com.
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 system. 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.