Last reviewed · How we verify
NCT06655610: eTNS4ADHD
External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial
NA trial testing External Trigeminal Nerve Stimulation in ADHD - Attention Deficit Disorder With Hyperactivity in 60 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | Psychiatric Research Unit, Region Zealand, Denmark |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 5 December 2024 |
| Primary completion | 31 August 2026 |
| Estimated completion | 25 November 2026 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- External Trigeminal Nerve Stimulation
- Sham device — full drug profile →
Conditions studied
- ADHD - Attention Deficit Disorder With Hyperactivity — all drugs for ADHD - Attention Deficit Disorder With Hyperactivity →
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):
-
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:
- PubMed search for NCT06655610
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06910605 — Exploring Parameters of Driving Simulation in Relation to Drug Holidays in ADHD Patients · NA · recruiting
Other Psychiatric Research Unit, Region Zealand, Denmark trials
Trials by the same sponsor.
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- NCT05172375 — Development of a Model for Shared Care in the Interface Between General Practice and Mental Health Care · NA · unknown
- NCT05243160 — Medication Reviews in Severe Mental Illness · NA · completed
- NCT05018312 — Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety · NA · unknown
- NCT05516238 — Systematic Use of Telepsychiatry for Outpatients · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06655610 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Psychiatric Research Unit, Region Zealand, Denmark
- Last refreshed: 9 March 2026
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