NCT06655610 External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial
| NCT ID | NCT06655610 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Psychiatric Research Unit, Region Zealand, Denmark |
| Condition | ADHD - Attention Deficit Disorder With Hyperactivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-12-05 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 7 to 17 years of age at the time of study enrollment. * A clinical diagnosis of ADHD according to criteria for ICD-10: F90.0, F91.0, F90.8, F90.9, F98.8C. The ADHD diagnosis must be verified by the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) using The Schedule for Affective Disorders and Schizophrenia for School-aged Children (K-SADS). * A score above 24 on the ADHD rating scale (ADHD-RS) at baseline. * Signed informed consent from parents/legal caretakers and from the patients aged ≥ 15. We will include treatment-naïve patients, patients who previously have received stimulant medication, and patients in stable, ongoing stimulant medication (methylphenidate or dexamphetamines/lisdexamphetamine) during the time of the trial. Exclusion Criteria: * Patients receiving atomoxetine and guanfacine at the time of study enrollment will be excluded all together * Epilepsy * Electronic or metallic implants. * Serious mental and/or somatic diseases other than ADHD, such as: * Pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9) * Schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29) * Mania or bipolar disorder (ICD-10 F30 and F31) * Depressive psychotic disorders (ICD-10 F32.3 + F33.3) * Substance dependence syndrome (ICD-10 F1x.2) * Cardio-vascular disorders * Cancer * An Intelligence quotient (IQ) below 70 measured by the Wechsler Intelligence Scale for Children * A substantial degree of restless sleep as reported by parents or caregivers and evaluated by the physician. * Other disabilities that may make use of Monarch problematic.
Contact & Investigator
Ole Jakob Storebø, Professor
PRINCIPAL INVESTIGATOR
Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark
Frequently Asked Questions
Who can join the NCT06655610 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying ADHD - Attention Deficit Disorder With Hyperactivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06655610 currently recruiting?
Yes, NCT06655610 is actively recruiting participants. Contact the research team at ojst@regionsjaelland.dk for enrollment information.
Where is the NCT06655610 trial being conducted?
This trial is being conducted at Slagelse, Denmark.
Who is sponsoring the NCT06655610 clinical trial?
NCT06655610 is sponsored by Psychiatric Research Unit, Region Zealand, Denmark. The principal investigator is Ole Jakob Storebø, Professor at Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark. The trial plans to enroll 60 participants.