Trigeminal nerve stimulation in children/adolescents with ADHD

Trigeminal nerve stimulation (TNS) has received FDA clearance in 2019 as the only device-based non-drug treatment for ADHD based on a pilot RCT that found medium sized improvement of symptoms in 62 children with ADHD. However, the no stimulation placebo control was weak. In our confirmatory multi-centre, double-blind, randomized, and rigorously sham-controlled, phase 2b RCT we tested short and longer-term efficacy (6 months) of real vs sham nightly TNS over 4 weeks in 150 youth with ADHD. Sham TNS provided 30s stimulation every hour. Improvement was tested in a wide range of ADHD-relevant clinical and cognitive measures, and in mechanistic measures of arousal and fMRI brain function The trial was successful, with over 93% adherence, compliance and retention, excellent safety and acceptability and successful blinding. However, real versus sham TNS showed no superior effects on clinical, cognitive, physiological or arousal measures after 4 weeks or 6 months nor on underlying fMRI brain activation [1,2]. The findings show that TNS is not a promising treatment for ADHD and highlight the importance to conduct large rigorously sham controlled trials to control for the large neurotechnology induced placebo/“neuroenchantment” effects typical for neurostimulation.

[1] Conti A,..Rubia K (2026). The efficacy of external Trigeminal Nerve Stimulation (TNS) in youth with Attention-Deficit/Hyperactivity Disorder (ADHD): a multi-centre, double-blind, randomized, sham-controlled, parallel-group, phase 2b trial. Nature Medicine, 32(2):582-590

[2] Eraydim IE,…Rubia K (2026) Effects of External Trigeminal Nerve Stimulation on Neurocognitive Functioning in Children and Adolescents with ADHD: A multicentre Randomized Controlled phase 2b Trial. AM J Psychiatry, in press