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.
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.
Patients receiving atomoxetine and guanfacine at the time of study enrollment will be excluded all together
Epilepsy
Electronic or metallic implants.
Pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9)
Psychiatric Research Unit, Region Zealand, Denmark
Lead sponsor
University of Southern Denmark
Sponsor institution