NeuroSigma Announces Publication of ADHD Clinical Trial Data That Provide Additional eTNS Mechanism of Action

NeuroSigma announces the publication on October 14, 2020 in the Journal of the American Academy of Child & Adolescent Psychiatry of a paper entitled Trigeminal Nerve Stimulation for Attention-Deficit Hyperactivity Disorder: Cognitive and Electrophysiological Predictors of Treatment Response.  The paper presents results of research conducted at UCLA as part of the pivotal trial of external TNS (eTNS) for pediatric ADHD that supported NeuroSigma's FDA clearance of the Monarch eTNS System.  The research was led by Sandra Loo, Ph.D., Professor of Psychiatry at the UCLA Semel Institute for Neuroscience and Human Behavior.

The objective of the research was to explore the applicability of a precision medicine approach to Trigeminal Nerve Stimulation by testing secondary outcomes of cognitive and electrophysiological (EEG) predictors of treatment response among subjects from the original randomized controlled trial.

As noted by the authors, while "the ~50% response rate of TNS is promising, principles based in precision medicine suggest that higher response rates might result from targeting the treatment to particular pathophysiological mechanisms underlying an individual patient's symptomatic presentation."

The research demonstrated that certain baseline characteristics such as lower working memory performance, deficits on the behavioral ratings of executive functions (BRIEF) scale, and lower resting state EEG power in the right frontal brain region were predictive of positive treatment response to eTNS (p < 0.05).  Further, upon completion of the four week eTNS treatment regimen, responders had significantly higher power in right frontal EEG readings, which was significantly correlated with improvement in executive function and ADHD symptoms.

Dr. Loo Said: "Our work with eTNS suggests that successful treatment response to eTNS appears to address a number of cognitive and neural deficits typically associated with ADHD, Additional investigations of this new treatment modality are warranted to better understand these effects, to predict which children may benefit prior to initiating treatment, and to provide independent replication in larger samples of children with ADHD."

Ian Cook, M.D., NeuroSigma's Chief Medical Officer Said: "Dr. Loo and her colleagues have done outstanding work in advancing our understanding of the eTNS mechanism of action, Specifically, the mechanism of action was demonstrated by the treatment-induced changes in frontal brain activity that showed a correlation with clinical outcome.  Their findings of baseline predictors of outcome suggest eTNS treatment can be especially valuable to some of the most impaired children with ADHD.  We look forward to  continuing to advance our eTNS portfolio based on these findings and to expanding our efforts in digital therapeutics," added Cook.  

Background – eTNS

In the United States NeuroSigma's Monarch eTNS System® is indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep. The most common side effects observed with eTNS use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events have been associated with use of the device.

In the European Union, the Monarch eTNS System is approved as adjunctive therapy for drug resistant epilepsy and major depressive disorder, as well as monotherapy for ADHD, all in patients 7 years and older.

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 attention-deficit hyperactivity disorder (ADHD) and other disorders.

Trigeminal Nerve Stimulation (TNS) is mild 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.

eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc

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