Last reviewed · How we verify

NCT06655610: eTNS4ADHD

External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial

Recruiting now NA Last updated 9 March 2026
What this trial tests

NA trial testing External Trigeminal Nerve Stimulation in ADHD - Attention Deficit Disorder With Hyperactivity in 60 participants. Currently enrolling.

Timeline
5 December 2024
Primary endpoint
31 August 2026
25 November 2026

Quick facts

Lead sponsorPsychiatric Research Unit, Region Zealand, Denmark
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment60
Start date5 December 2024
Primary completion31 August 2026
Estimated completion25 November 2026
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Psychiatric Research Unit, Region Zealand, Denmark

Who can join

Adults 7 to 17, any sex, with ADHD - Attention Deficit Disorder With Hyperactivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators will assess the use of the Monarch eTNS device as a non-pharmacological treatment for patients aged 7 to 17 years with ADHD. The investigators will compare the eTNS device to a sham device. Participants will use the device for four weeks during night time. During the trial, participants will receive different questionaires to assess symptoms and will also keep a logbook to record their experience with the device. At the end of trial, the investigators will assess what the families thought of the device, and whether it is indeed feasible to further explore the effect of the device in a larger clinical trial.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. External trigeminal nerve stimulation versus sham stimulation for attention deficit hyperactivity disorder in children and adolescents aged 7-17 years: study protocol for a pilot and feasibility randomized clinical trial.
    Edemann-Callesen H, Huus CL, Karstoft C, Bjarnadóttir E, et al · · 2025 · PMID 40518459 · DOI 10.1007/s00787-025-02786-7

Verify or expand the search:

Other recruiting trials for ADHD - Attention Deficit Disorder With Hyperactivity

Currently open trials in the same condition.

Other Psychiatric Research Unit, Region Zealand, Denmark trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06655610.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing