Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder.

Abstract

OBJECTIVE:

Trigeminal nerve stimulation (TNS), a minimal-risk noninvasive neuromodulation method, showed potential benefits for attention-deficit/hyperactivity disorder (ADHD) in an unblinded open study. The present blinded sham-controlled trial was conducted to assess the efficacy and safety of TNS for ADHD and potential changes in brain spectral power using resting-state quantitative electroencephalography.

METHOD:

Sixty-two children 8 to 12 years old, with full-scale IQ of at least 85 and Schedule for Affective Disorders and Schizophrenia-diagnosed ADHD, were randomized to 4 weeks of nightly treatment with active or sham TNS, followed by 1 week without intervention. Assessments included weekly clinician-administered ADHD Rating Scales (ADHD-RS) and Clinical Global Impression (CGI) scales and quantitative electroencephalography at baseline and week 4.

RESULTS:

ADHD-RS total scores showed significant group-by-time interactions (F1,228 = 8.12, p = .005; week 4 Cohen d = 0.5). CGI-Improvement scores also favored active treatment (χ21,168 = 8.75, p = .003; number needed to treat = 3). Resting-state quantitative electroencephalography showed increased spectral power in the right frontal and frontal midline frequency bands with active TNS. Neither group had clinically meaningful adverse events.

CONCLUSION:

This study demonstrates TNS efficacy for ADHD in a blinded sham-controlled trial, with estimated treatment effect size similar to non-stimulants. TNS is well tolerated and has minimal risk. Additional research should examine treatment response durability and potential impact on brain development with sustained use.

CLINICAL TRIAL REGISTRATION INFORMATION:

Trigeminal Nerve Stimulation for ADHD; http://clinicaltrials.gov/; NCT02155608.

• Authors: James J McGough, Alexandra Sturm, Jennifer Cowen, Kelly Tung, Giulia C Salgari, Andrew F Leuchter, Ian A Cook, Catherine A Sugar, Sandra K Loo
• Journal: Journal of the American Academy of Child and Adolescent Psychiatry (J Am Acad Child Adolesc Psychiatry) Vol. 58 Issue 4 Pg. 403-411.e3 (04 2019) ISSN: 1527-5418 [Electronic] United States
• PMID: 30768393 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2019 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Topics

• Attention Deficit Disorder with Hyperactivity (therapy)
• Child
• Double-Blind Method
• Electric Stimulation Therapy (methods)
• Executive Function
• Female
• Humans
• Logistic Models
• Male
• Pilot Projects
• Psychiatric Status Rating Scales
• Treatment Outcome
• Trigeminal Nerve (physiology)
• United States