Using a device to stimulate the trigeminal nerve for treating ADHD in children
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
This study is testing whether a device that stimulates a nerve in the head can help children and teens with ADHD feel better without using medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | Psychiatric Research Unit, Region Zealand, Denmark Academic / other |
| Locations | 1 site (Slagelse, Region Sjælland) |
| Trial ID | NCT06655610 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the feasibility of using the Monarch external trigeminal nerve stimulation (eTNS) device as a non-pharmacological treatment for children and adolescents aged 7 to 17 years diagnosed with ADHD. Participants will be randomly assigned to receive either the active eTNS device or a sham device for four weeks during nighttime. Throughout the trial, families will complete questionnaires and maintain logbooks to track their experiences and symptoms. The study aims to assess treatment compliance, completion rates, and gather feedback from families to determine the potential for a larger clinical trial.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 7 to 17 years with a clinical diagnosis of ADHD.
Not a fit: Patients currently receiving atomoxetine or guanfacine, or those with epilepsy or electronic/metallic implants, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option for children with ADHD, reducing reliance on medication.
How similar studies have performed: While the use of eTNS for ADHD is relatively novel, previous studies have indicated its potential effectiveness, warranting further investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Slagelse, Region Sjælland
- Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark — Slagelse, Region Sjælland, Denmark (Recruiting)
Study contacts
- Principal investigator: Ole Jakob Storebø, Professor — Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark
- Study coordinator: Ole Jakob Storebø, Professor
- Email: ojst@regionsjaelland.dk
- Phone: 452-496-5917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.