External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial
Recruiting · NCT06655610 · Interventional (participants receive a specific treatment) · Lead sponsor: Psychiatric Research Unit, Region Zealand, Denmark
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
1 location listed.
- Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark - Slagelse, Region Sjælland, Denmark