Overview
- The peer-reviewed Nature Medicine study randomized 150 UK youths aged 8–18 to active or sham external trigeminal nerve stimulation for four weeks with overnight use.
- An intermittent, hourly pulse sham preserved masking, and both groups showed similar improvement on the primary ADHD Rating Scale with no significant between-group difference.
- Most secondary and physiological measures, including sleep, anxiety, activity trackers, and pupil arousal, showed no advantage for active stimulation.
- An isolated signal of greater reduction in self-reported mind-wandering emerged with active treatment, which authors said does not support broad clinical use.
- Safety and adherence were strong, yet investigators said the null results challenge the 2019 FDA clearance based on a 62-participant pilot that lacked an active-mimicking control and may warrant regulatory and guideline reassessment.