Efficacy of Trigeminal Nerve Stimulation for ADHD
Attention-Deficit Hyperactivity Disorder
About this trial
This is an interventional treatment trial for Attention-Deficit Hyperactivity Disorder focused on measuring ADHD, Neuromodulation, Trigeminal Nerve Stimulation, Cognition, EEG
Eligibility Criteria
Inclusion Criteria:
- male and female children ages 7 to 12 years with DSM-5 ADHD, any current presentation, as determined by diagnostic interview, Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), and clinical interview;
- minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-RS;
- CGI-S score at baseline >= 4;
- no current medication with CNS effects (Participants previously on psychostimulant medication will be required to be not optimally treated and off medication for one week or 5 half-lives for all other medications); stable use of supplements will be permitted;
- parents able and willing to monitor proper use of the stimulation device and complete all required rating scales;
- estimated Full Scale IQ >= 80 based on WASI subtests;
- parent and participant able to complete rating scales and other measures in English;
- able to cooperate during EEG
Exclusion Criteria:
- impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator;
- current diagnosis of autism spectrum disorder or major depression;
- history of lifetime psychosis, mania, or seizure disorder;
- baseline suicidality;
- history of seizure disorder or head injury with loss of consciousness
Sites / Locations
- University of California, Los AngelesRecruiting
- Seattle Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active eTNS
Sham eTNS
Following screening and determination of eligibility , participants at baseline are randomized to receive 4 weeks nightly treatment with active eTNS. Positive responders will be invited to participate in a 12-month open-label continuation phase.
Following screening and determination of eligibility, participants at baseline are randomize to receive 4 weeks nightly treatment with sham eTNS. At conclusion of the double-blind phase, participants randomized to sham will be provided an opportunity to receive an additional 4 weeks nightly treatment with active eTNS. Positive responders to active eTNS will be invited to participate in a 12-month open-label continuation phase.