Overview
- The multicenter, randomized, sham-controlled phase 2b trial led by King’s College London and the University of Southampton tested trigeminal nerve stimulation in 150 participants aged 8–18.
- Participants used the device nightly for four weeks, with half receiving active stimulation and half an enhanced sham that delivered brief, low-level pulses designed to maintain blinding.
- No meaningful differences emerged between groups on parent-rated ADHD symptoms or secondary measures including attention, hyperactivity, mood, sleep, and objective markers.
- The device was well tolerated with no serious adverse events, and researchers highlighted a strong placebo response, noting successful blinding and similar improvements in both arms.
- The findings challenge the 2019 FDA clearance based on a small pilot without an active sham; NICE does not recommend the treatment, and investigators plan further analyses of collected imaging data.