Evidence map›Paper›PMID 41545587›Full record

Trial reportNature medicine2026

External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial.

Aldo Alberto Conti, Natali Bozhilova, Irem Ece Eraydin, Dominic Stringer, Lena Johansson, Robert Marhenke, Andrea Bilbow, Sahid El Masri, Joshua Hyde, Giovanni Giaroli and 7 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Nature medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Child and adolescent psychiatry: challenges, solutions, opportunities, and future directions.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Aldo Alberto Conti *Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neurosciences King's College London, London, UK.ORCID http://orcid.org/0000-0002-0467-9431
Natali Bozhilova *Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neurosciences King's College London, London, UK.
Irem Ece Eraydin *Developmental EPI (Evidence synthesis, Prediction, Implementation) Lab, Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.ORCID http://orcid.org/0000-0002-3468-1719
Dominic StringerDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.ORCID http://orcid.org/0000-0001-5624-1733
Lena JohanssonDepartment of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neurosciences King's College London, London, UK.ORCID http://orcid.org/0000-0002-4473-1134
Robert MarhenkeDevelopmental EPI (Evidence synthesis, Prediction, Implementation) Lab, Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.ORCID http://orcid.org/0000-0001-7760-8661
Andrea BilbowAttention Deficit Disorder Information and Support Services (ADDISS), Edgware, UK.
Sahid El MasriDepartment of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neurosciences King's College London, London, UK.ORCID http://orcid.org/0009-0008-6259-2079
Joshua HydeDevelopmental EPI (Evidence synthesis, Prediction, Implementation) Lab, Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.
Giovanni GiaroliThe Giaroli Centre, London, UK.
Holan LiangThe Assessment Team, Hertfordshire, UK.ORCID http://orcid.org/0000-0001-6650-9449
Federico FioriDepartment of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neurosciences King's College London, London, UK.
Mitul Ashok MehtaDepartment for Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.ORCID http://orcid.org/0000-0003-1152-5323
Paramala SantoshDepartment of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neurosciences King's College London, London, UK.ORCID http://orcid.org/0000-0003-4830-5893
Ben CarterDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.ORCID http://orcid.org/0000-0003-0318-8865
Samuele CorteseDevelopmental EPI (Evidence synthesis, Prediction, Implementation) Lab, Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.ORCID http://orcid.org/0000-0001-5877-8075
Katya RubiaDepartment of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neurosciences King's College London, London, UK. katya.rubia@kcl.ac.uk.ORCID http://orcid.org/0000-0002-1410-7701

Funding

DH | NIHR | Efficacy and Mechanism Evaluation Programme (NIHR Efficacy and Mechanism Evaluation Programme) NIHR130077
6 · The paper itself

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 stimulation targeted V1 trigeminal branches using battery-powered electrodes applied to the forehead. Sham TNS delivered 30 seconds of stimulation per hour at lower frequency and pulse width. Intention-to-treat analysis showed no significant differential treatment effects on ADHD symptoms (primary outcome) (estimated adjusted mean difference = 0.83; 95% confidence interval: -2.47 to 4.13; P = 0.622; Cohen's d = 0.09). No serious adverse events were reported, and side effects did not differ between groups. In conclusion, TNS is a safe intervention but does not demonstrate clinical efficacy for pediatric ADHD. Trial registration: ISRCTN82129325 .

Indexed as

Attention Deficit Disorder with HyperactivityElectric Stimulation TherapyTrigeminal NerveAdolescentChildDouble-Blind MethodFemaleHumansMaleTreatment Outcome

Identifiers

PMID41545587
PMCPMC12920111

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.