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Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity
James J McGough1, Alexandra Sturm1, Jennifer Cowen1
1Semel Institute for Neuroscience and Human Behavior and the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), Los Angeles, CA.
Journal of the American Academy of Child and Adolescent Psychiatry
|February 16, 2019
Summary
Trigeminal nerve stimulation (TNS) effectively treated attention-deficit/hyperactivity disorder (ADHD) in children. This noninvasive method is safe, well-tolerated, and shows potential for ADHD symptom management.
Area of Science:
- Neuroscience
- Neuromodulation
- Child Psychiatry
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder.
- Noninvasive neuromodulation techniques are being explored as potential ADHD treatments.
- Trigeminal nerve stimulation (TNS) is a minimal-risk method with prior suggested benefits for ADHD.
Purpose of the Study:
- To evaluate the efficacy and safety of TNS for treating ADHD in children.
- To assess changes in brain spectral power using quantitative electroencephalography (qEEG) during TNS treatment.
- To conduct a blinded, sham-controlled trial to validate TNS effectiveness.
Main Methods:
- A 4-week randomized, double-blind, sham-controlled trial involving 62 children (8-12 years) diagnosed with ADHD.
- Participants received nightly active or sham TNS.
- Assessments included ADHD Rating Scales (ADHD-RS), Clinical Global Impression (CGI) scales, and resting-state qEEG.
Main Results:
- Significant improvements in ADHD-RS total scores and CGI-Improvement scores were observed in the active TNS group compared to sham.
- Active TNS led to increased spectral power in right frontal and frontal midline frequency bands on qEEG.
- No clinically significant adverse events were reported in either group.
Conclusions:
- Trigeminal nerve stimulation (TNS) is an effective and well-tolerated treatment for ADHD in children.
- The findings support TNS as a safe, noninvasive therapeutic option for ADHD.
- Further research is recommended to explore long-term effects and impact on brain development.
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