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J Am Acad Child Adolesc Psychiatry. 2019 Apr;58(4):403-411.e3. doi: 10.1016/j.jaac.2018.11.013. Epub 2019 Jan 28.

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

Author information

1
Semel Institute for Neuroscience and Human Behavior and the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), Los Angeles, CA. Electronic address: jmcgough@mednet.ucla.edu.
2
Semel Institute for Neuroscience and Human Behavior and the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), Los Angeles, CA.
3
David Geffen School of Medicine at UCLA, the Henry Samueli School of Engineering and Applied Science at UCLA, and NeuroSigma, Inc., Los Angeles, CA.
4
David Geffen School of Medicine and the Fielding School of Public Health at UCLA, Los Angeles, CA.

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.

KEYWORDS:

attention-deficit/hyperactivity disorder; clinical trial; neuromodulation; trigeminal nerve stimulation

PMID:
30768393
PMCID:
PMC6481187
[Available on 2020-04-01]
DOI:
10.1016/j.jaac.2018.11.013
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