FDA-Approved Nerve Stimulation Device For ADHD Is Ineffective, Clinical Trial Concludes

Key TakeawaysAn approved device for treating ADHD doesn’t workThe device produced no significant improvements in ADHD symptoms after a month, compared to placeboResearchers said flawed study design in earlier trials led to results that supported the U.S. Food and Drug Administration's approval.TUESDAY, Jan. 20, 2026 (HealthDay News) — A U.S. Food and Drug Administration (FDA)-approved device for treating ADHD in kids simply doesn’t work, a new clinical trial says.The device — an external trigeminal nerve stimulator — was not effective in reducing symptoms of ADHD compared to placebo, researchers reported Jan. 16 in the journal Nature Medicine.The FDA based its approval on results from a smaller previous trial that made crucial errors when it came to the placebo condition, researchers said.“Our study shows how important it is to design an appropriate placebo condition in clinical trials of brain therapies,” said senior researcher Katya Rubia, a professor of cognitive neuroscience at King’s College London.“There is a large placebo effect with high-tech brain therapies, in particular for patients and families that have an expectation that they can adjust brain differences associated with ADHD,” Rubia said in a news release. “It is hence paramount to control for placebo effects in modern brain therapies to avoid false hopes.”The FDA approved external trigeminal nerve stimulation (TNS) in 2019 as the first non-drug device for treating ADHD, researchers said in background notes.The treatment involves placing electrodes on the foreheads of children with ADHD while they sleep.The battery-powered electrodes stimulate the trigeminal nerve, targeting a branch of the facial nerve thought to activate the brainstem and, from there, other brain regions linked to ADHD, researchers said.The FDA’s approval came following a small U.S. trial involving 62 children, researchers said. Results in that earlier trial showed that children’s ADHD symptoms were reduced after stimulation was applied eight hours a night for a month.However, that trial compared the stimulator against no stimulation at all, raising the possibility that a placebo effect could be clouding the results, researchers said. Kids knew whether or not they were receiving stimulation, and that might have influenced how they responded.To proof-test the earlier trial’s findings, researchers performed a follow-up trial in the U.K. involving a wider range of 150 children and teenagers with ADHD and using a more rigorous placebo method.Half of the kids received real stimulation for about nine hours every night for four weeks. The other half received a “sham” treatment in which electrodes were applied but the kids only received 30 seconds of stimulation an hour at a lower, non-effective level.After a month, no significant differences were found in ADHD symptoms between the two groups of kids.The treatment is safe, producing no serious side effects, results showed. It just doesn’t work.“This multicenter trial was designed to address key limitations of the previous pilot study that informed FDA clearance of TNS for ADHD," lead researcher Aldo Conti, a postdoctoral researcher at King’s College London, said in a news release.“Unlike the earlier study, which was limited to younger children, we also included adolescents, a clinically important group given well-documented challenges with long-term medication adherence,” Conti said. “These design choices enabled a more robust and clinically relevant evaluation of TNS.”Parents and doctors should consider these results when weighing whether to try trigeminal nerve stimulation, researchers said.“Rigorous evidence, such as that generated by this study, is essential for supporting shared decision-making regarding interventions for ADHD,” said investigator Dr. Samuele Cortese, a research professor at the University of Southampton in the U.K.“It empowers individuals with ADHD and their families to make informed choices about the treatment of ADHD,” Cortese said in the news release. “Clinicians, individuals with ADHD, and their families need to know which treatments work, and which do not based on the best evidence.”More informationThe U.S. Food and Drug Administration has more on its approval of trigeminal nerve stimulation.SOURCE: King’s College London, news release, Jan. 16, 2026 .What This Means For YouParents should consider the results of this trial when deciding whether to try trigeminal nerve stimulation on their child with ADHD, researchers say..Sign up for our weekly HealthDay newsletter

FDA-Approved Nerve Stimulation Device For ADHD Is Ineffective, Clinical Trial Concludes

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