Actively Recruiting
External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial
Led by Psychiatric Research Unit, Region Zealand, Denmark · Updated on 2026-03-09
60
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 7 to 17 years of age at the time of study enrollment.
- Clinical diagnosis of ADHD according to ICD-10 codes F90.0, F91.0, F90.8, F90.9, or F98.8C, verified by DSM-5 using K-SADS.
- ADHD rating scale (ADHD-RS) score above 24 at baseline.
- Signed informed consent from parents or legal caretakers, and from patients aged 15 or older.
- Includes treatment-na�ve patients, those previously treated with stimulants, and those on stable stimulant medication (methylphenidate or dexamphetamines/lisdexamphetamine).
You will not qualify if you...
- Current treatment with atomoxetine or guanfacine.
- Epilepsy.
- Presence of electronic or metallic implants.
- Serious mental or somatic diseases other than ADHD, including:
- Pervasive developmental disorder (excluding Asperger's syndrome).
- Schizophrenia or paranoid psychosis.
- Mania or bipolar disorder.
- Depressive psychotic disorders.
- Substance dependence syndrome.
- Cardiovascular disorders.
- Cancer.
- IQ below 70 measured by the Wechsler Intelligence Scale for Children.
- Significant restless sleep as reported by parents or caregivers and evaluated by a physician.
- Other disabilities that may interfere with use of the Monarch device.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark
Slagelse, Region Sjælland, Denmark, 4200
Actively Recruiting
Research Team
O
Ole Jakob Storebø, Professor
CONTACT
H
Henriette Edemann-Callesen, Phd, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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