Aldo Conti, PhD, says trigeminal nerve stimulation ineffective for pediatric ADHD

In a recent interview with Contemporary Pediatrics, Aldo A. Conti, BSc, MSc, PhD, CPsychol, research associate at King’s College London, discussed findings from a large, multicenter clinical trial evaluating the safety and efficacy of trigeminal nerve stimulation (TNS), a noninvasive brain stimulation device marketed for children and adolescents with attention-deficit/hyperactivity disorder (ADHD).

Although the device had previously received FDA clearance based on a small US pilot study, Conti’s team found no evidence that it improved ADHD symptoms beyond placebo effects. The study assessed external TNS in 150 children and adolescents aged 8 to 18 years across 2 research sites. Participants were randomized to receive either active TNS or a sham condition.

While the intervention was found to be safe, with no serious adverse events reported, it did not demonstrate clinical efficacy. Most participants experienced no side effects, and those reported were mild, including headaches or difficulty falling asleep. Importantly, there were no significant differences in symptom improvement between the active and sham groups.

Conti highlighted several strengths of the current trial compared with the earlier pilot study that informed FDA clearance. These included a multicenter design to enhance generalizability, a substantially larger sample size, and the inclusion of adolescents, a clinically important group not studied previously. The researchers also examined longer-term outcomes, assessing whether any treatment effects persisted up to 6 months after the intervention, whereas the original pilot study only evaluated outcomes 4 weeks post-treatment.

In addition, the study incorporated more objective outcome measures than prior trials. Alongside standard assessments of ADHD symptoms, the investigators used neuroimaging to evaluate potential effects of TNS on brain function, wristband-based devices to measure objective hyperactivity, and pupillometry to assess changes in arousal. None of these measures showed evidence of benefit from active TNS.

Based on these findings, Conti emphasized that although TNS appears to be safe, it should not be prioritized over established first-line ADHD treatments, such as stimulant medications. He cautioned clinicians to rely on rigorous, well-powered evidence when advising families about novel interventions, noting that FDA clearance indicates safety but does not guarantee efficacy.

Looking ahead, Conti suggested future research should continue to use objective measures to better understand how brain stimulation affects neural systems and to identify subgroups of patients who might benefit. He also proposed studying combined approaches, such as brain stimulation alongside medication, or conducting direct comparative trials against standard treatments. Overall, he underscored the importance of grounding clinical decision-making in strong, high-quality evidence when managing pediatric ADHD.

No relevant disclosures.

References

1. Brain stimulation device cleared for ADHD in the US is overall safe but ineffective. King’s College London. January 16, 2026. Accessed February 3, 2026. https://www.eurekalert.org/news-releases/1112531
2. Conti AA, Bozhilova N, Eraydin IE, et al. External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial. Nat Med. 2026. doi.org/10.1038/s41591-025-04075-x