A phase 2b study titled “External trigeminal nerve stimulation in youth with ADHD: randomized, sham-controlled” was published in Nature Medicine on January 16, 2026.[1] This is a large multicenter, double-blind, randomized controlled trial of 150 children and adolescents aged 8 to 18 years with a diagnosis of ADHD.[1][5] Half of the participants received real external trigeminal nerve stimulation (TNS) for approximately 9 hours each night for four weeks via battery-powered forehead electrodes, the other half sham treatment.[1][5] The study was conducted at two sites in London and Southampton and used a strict placebo condition to ensure successful blinding.[1][5] External trigeminal nerve stimulation was safe, with no serious adverse events, and most participants found it to be of little or no burden to use.[1][5] However, it did not produce significant changes in ADHD symptoms, objective measures of hyperactivity, attention, or mood- and sleep-related behaviors compared to sham treatment.[1][5] The results suggest that authorities should reevaluate the original evidence on which the FDA approved TNS for ADHD in 2019.[1][5]