External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial

Recruiting N/A Interventional Study
ADHD - Attention Deficit Disorder With Hyperactivity
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
7 – 17
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Psychiatric Research Unit, Region Zealand, Denmark · Other
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About This Trial
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 recor…
Trial Locations
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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 Schedu…
Contacts

Ole Jakob Storebø, Professor

452-496-5917

ojst@regionsjaelland.dk

CONTACT

Henriette Edemann-Callesen, Phd, MD

452-834-3531

henriette.callesen@gmail.com

CONTACT