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First double-blind controlled trial of TNS shows reduced symptoms in some children with ADHD

March 12, 2019

Washington, DC, March 12, 2019

Currently approved in Canada and Europe for adults with medication-resistant depression and seizures, trigeminal nerve stimulation (TNS) has been found to be an effective and safe means of treatment for children with attention deficit hyperactivity disorder (ADHD), reports a study published in the April 2019 issue of the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP).

TNS utilizes a small stimulator worn on a child's clothes to emit a low-level current, powered by a 9-volt battery. Thin wires are connected to the device with an adhesive electrode patch worn across the forehead during sleep. Mild stimulation to the skin, barely or not perceptible to the child, led to activation of deeper brain areas associated with concentration and impulse control. Children wore the patch an average of eight hours nightly and patches were removed each morning.

"ADHD is estimated to affect 9.5 percent of school-age children and 4.4 percent of adults," said James McGough, MD, Professor and child psychiatrist at the Jane & Terry Semel Institute for Neuroscience and Human Behavior at University of California, Los Angeles, CA, USA. "Our current treatments mostly depend on medication with some role for behavioral therapies. Although there is great demand for non-medication ADHD treatments, the most popular options have minimal, if any, scientific evidence supporting their use."

Investigators enrolled 62 children ages 8-12 years old and randomized them to receive active or sham TNS nightly for 4 weeks. Benefits in the active group were observed within the first week of treatment, with increasing improvement over the remaining weeks. Improvement compared with the sham group was demonstrated by the ADHD-Rating Scale (p = .005), the study's primary outcome measure, and the Clinical Global Impression - Improvement scale (p = .003). The size of treatment improvement was similar to that seen with currently FDA-approved nonstimulant ADHD medications.

In addition to reductions in behavioral ADHD symptoms, investigators found positive changes in brain activation with active TNS, measured by electroencephalography (EEG). This finding, consistent with NIMH research priorities, emphasize measurable changes in neurological functioning in addition to behavioral improvement, suggesting that TNS has beneficial effects by increasing activity in brain circuits that modulate hyperactivity and impulsivity. Study results further suggested that TNS might be effective in reducing pediatric anxiety symptoms, consistent with other studies of TNS for adult depression and post-traumatic stress disorder.

A major limitation of many studies of non-medication ADHD treatments relates to difficulties maintaining effective blinding of the sham control condition. Investigators in this study demonstrated that after the initial week, parents of children in both active and sham TNS groups had equal expectation of benefit, suggesting that the study design successfully concealed which treatment children were receiving. This result, in addition to differences in brain activation measured by EEG, further supports the study's conclusion regarding the potential of TNS for ADHD therapy.

"I am excited that we found significant reductions in ADHD symptoms, as well as associated improvements in brain functioning, as a result of TNS therapy," added Dr. McGough, the lead author of the study. "Treatment was well accepted by patients and families, compliance was high, and there were no clinically important side effects. TNS has great potential as an additional option for managing ADHD."

-end-


Notes for editors
The article is "Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation (TNS) for ADHD," by James J. McGough, MD, Alexandra Sturm, PhD, Jennifer Cowen, PhD, Kelly Tung, BS, Giulia C. Salgari, MS, Andrew F. Leuchter, MD, Ian A. Cook, MD, Catherine A. Sugar, PhD, Sandra K. Loo, PhD (https://doi.org/10.1016/j.jaac.2018.11.013). It appears in the Journal of the American Academy of Child and Adolescent Psychiatry, volume 58, issue 4 (April 2019), published by Elsevier.



Dr. McGough is Professor of Clinical Psychiatry at Biobehavioral Sciences at the Jane & Terry Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine, University of California, Los Angeles (UCLA). Dr. McGough is a consultant to the US Food and Drug Administration (USFDA) and National Institute of Mental Health (NIMH). He is a Distinguished Fellow of the American Academy of Child and Adolescent Psychiatry and a Distinguished Life Fellow of the American Psychiatric Association.

The study was funded with a grant from the US National Institute of Mental Health (NIMH). NeuroSigma Inc., maker of the Monarch external trigeminal nerve stimulation (eTNS™) system used in the study, provided additional material support for the research.

Copies of this paper are available to credentialed journalists upon request; please contact Mary Billingsley at mbillingsley@aacap.org or +1 202 587 9672. Journalists wishing to interview the author may contact James J. McGough, MD, 300 UCLA Medical Plaza, Suite 1524C, Los Angeles, CA 90095 at jmcgough@mednet.ucla.edu.

About JAACAP
Journal of the American Academy of Child and Adolescent Psychiatry
(JAACAP) is the official publication of the American Academy of Child and Adolescent Psychiatry. JAACAP is the leading journal focusing exclusively on today's psychiatric research and treatment of the child and adolescent. Published twelve times per year, each issue is committed to its mission of advancing the science of pediatric mental health and promoting the care of youth and their families.

The Journal's purpose is to advance research, clinical practice, and theory in child and adolescent psychiatry. It is interested in manuscripts from diverse viewpoints, including genetic, epidemiological, neurobiological, cognitive, behavioral, psychodynamic, social, cultural, and economic. Studies of diagnostic reliability and validity, psychotherapeutic and psychopharmacological treatment efficacy, and mental health services effectiveness are encouraged. The Journal also seeks to promote the well-being of children and families by publishing scholarly papers on such subjects as health policy, legislation, advocacy, culture and society, and service provision as they pertain to the mental health of children and families. http://www.jaacap.org

About Elsevier
Elsevier is a global information analytics business that helps scientists and clinicians to find new answers, reshape human knowledge, and tackle the most urgent human crises. For 140 years, we have partnered with the research world to curate and verify scientific knowledge. Today, we're committed to bringing that rigor to a new generation of platforms. Elsevier provides digital solutions and tools in the areas of strategic research management, R&D performance, clinical decision support, and professional education; including ScienceDirect, Scopus, SciVal, ClinicalKey and Sherpath. Elsevier publishes over 2,500 digitized journals, including The Lancet and Cell, 39,000 e-book titles and many iconic reference works, including Gray's Anatomy. Elsevier is part of RELX Group, a global provider of information and analytics for professionals and business customers across industries. http://www.elsevier.com

Media contact
Mary Billingsley
JAACAP Editorial Office
+1 202 587 9672
mbillingsley@aacap.org

Elsevier

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