{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Conti AA"],"funding":["National Institute for Health Research (NIHR)","DH | NIHR | Efficacy and Mechanism Evaluation Programme (NIHR Efficacy and Mechanism Evaluation Programme)"],"pagination":["582-590"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12920111"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["32(2)"],"pubmed_abstract":["External trigeminal nerve stimulation (TNS) received US Food and Drug Administration clearance in 2019 as the first device-based, non-pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD), based on a small pilot sham-controlled randomized controlled trial (RCT) that reported symptom improvement in 62 children with ADHD. Here we conducted a confirmatory multicenter, double-blind, randomized, sham-controlled, parallel-group, phase 2b RCT to investigate short-term and long-term efficacy (6 months) of real versus sham TNS in 150 children and adolescents with ADHD. Participants were randomized to receive real TNS (n = 75, mean age (s.d.) = 12.6 (2.8) years) or sham TNS (n = 75, mean age (s.d.) = 12.6 (2.8) years) nightly for approximately 9 hours for 4 weeks. Bilateral s"],"journal":["Nature medicine"],"pubmed_title":["External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial."],"pmcid":["PMC12920111"],"funding_grant_id":["17/32/04","RP-PG-0618-20003","NIHR203684","NIHR203035","NIHR158490","NIHR127921","NIHR127951","NIHR207448","NIHR128472","NIHR165421","NIHR130674","NIHR130730","NIHR154546","NIHR303122","NIHR130077","NIHR131175"],"pubmed_authors":["Mehta MA","Conti AA","Bilbow A","Hyde J","Giaroli G","Carter B","El Masri S","Marhenke R","Santosh P","Stringer D","Liang H","Cortese S","Bozhilova N","Fiori F","Johansson L","Rubia K","Eraydin IE"],"additional_accession":[]},"is_claimable":false,"name":"External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial.","description":"External trigeminal nerve stimulation (TNS) received US Food and Drug Administration clearance in 2019 as the first device-based, non-pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD), based on a small pilot sham-controlled randomized controlled trial (RCT) that reported symptom improvement in 62 children with ADHD. Here we conducted a confirmatory multicenter, double-blind, randomized, sham-controlled, parallel-group, phase 2b RCT to investigate short-term and long-term efficacy (6 months) of real versus sham TNS in 150 children and adolescents with ADHD. Participants were randomized to receive real TNS (n = 75, mean age (s.d.) = 12.6 (2.8) years) or sham TNS (n = 75, mean age (s.d.) = 12.6 (2.8) years) nightly for approximately 9 hours for 4 weeks. Bilateral s","dates":{"release":"2026-01-01T00:00:00Z","publication":"2026 Feb","modification":"2026-07-16T12:33:59.316Z","creation":"2026-07-09T10:55:39.799Z"},"accession":"S-EPMC12920111","cross_references":{"pubmed":["41545587"],"doi":["10.1038/s41591-025-04075-x"]}}