Using a device to stimulate the trigeminal nerve for treating ADHD in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.