Clinical Efficacy of Trigeminal Nerve Stimulation in Pediatric ADHD: A Double-Blind Randomized Controlled Trial
Abstract
Trigeminal Nerve Stimulation (TNS) represents a promising non-pharmacological monotherapy for pediatric Attention-Deficit/Hyperactivity Disorder (ADHD), yet its efficacy and underlying neurobiological mechanisms remain intensely debated. Here, we present a randomized controlled trial (N = 218) evaluating active (120 Hz) versus active-control (2 Hz) TNS in ADHD. Although robust active-control responses attenuated differences on traditional continuous symptom scales, blinded clinician-rated Clinical Global Impression of Improvement scales revealed a 35% binary response rate in the active cohort compared to 15% in the control arm (OR = 3.07; 95% CI: 1.45–6.24; p = 0.002). Concurrent quantitative electroencephalography demonstrated that active TNS selectively modulates right frontal alpha power—an effect moderated by biological sex, emerging in boys but not in girls. These data validate the clinical efficacy of TNS, highlight the semi-active nature of low-frequency cranial nerve stimulation, and provide a sex-specific neurophysiological framework for targeted pediatric neuromodulation.
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BibTeX
@misc{loo2026clinical,
title = {{Clinical Efficacy of Trigeminal Nerve Stimulation in Pediatric ADHD: A Double-Blind Randomized Controlled Trial}},
author = {Sandra Loo and Andrea Dillon and Giulia Salgari and Kelsey Stiles and Jennifer Cowen and Stella Chang and Catherine Sugar and James McGough and Fiona Whelan},
howpublished = {Research Square},
year = {2026},
month = oct,
doi = {10.21203/rs.3.rs-11461111/v1},
url = {https://doi.org/10.21203/rs.3.rs-11461111/v1},
note = {CC BY 4.0},
}
RIS
TY - UNPB
TI - Clinical Efficacy of Trigeminal Nerve Stimulation in Pediatric ADHD: A Double-Blind Randomized Controlled Trial
AU - Sandra Loo
AU - Andrea Dillon
AU - Giulia Salgari
AU - Kelsey Stiles
AU - Jennifer Cowen
AU - Stella Chang
AU - Catherine Sugar
AU - James McGough
AU - Fiona Whelan
PY - 2026
DA - 2026/10/30
PB - Research Square
DO - 10.21203/rs.3.rs-11461111/v1
UR - https://doi.org/10.21203/rs.3.rs-11461111/v1
AB - Trigeminal Nerve Stimulation (TNS) represents a promising non-pharmacological monotherapy for pediatric Attention-Deficit/Hyperactivity Disorder (ADHD), yet its efficacy and underlying neurobiological mechanisms remain intensely debated. Here, we present a randomized controlled trial (N = 218) evaluating active (120 Hz) versus active-control (2 Hz) TNS in ADHD. Although robust active-control responses attenuated differences on traditional continuous symptom scales, blinded clinician-rated Clinical Global Impression of Improvement scales revealed a 35% binary response rate in the active cohort compared to 15% in the control arm (OR = 3.07; 95% CI: 1.45–6.24; p = 0.002). Concurrent quantitative electroencephalography demonstrated that active TNS selectively modulates right frontal alpha power—an effect moderated by biological sex, emerging in boys but not in girls. These data validate the clinical efficacy of TNS, highlight the semi-active nature of low-frequency cranial nerve stimulation, and provide a sex-specific neurophysiological framework for targeted pediatric neuromodulation.
SN - 2693-5015
ER -