NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company focused on commercialization of its non-invasive eTNS technology, announced that enrollment has commenced for a 90-subject phase II paediatric 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 US 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' programme," 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.