Status:
RECRUITING
Efficacy of Trigeminal Nerve Stimulation for ADHD
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Attention-Deficit Hyperactivity Disorder
Eligibility:
All Genders
7-12 years
Phase:
NA
Brief Summary
This study is a large multisite randomized clinical trial to asses the efficacy of external trigeminal nerve stimulation (TNS), a novel, minimal risk, non-invasive neuromodulation treatment, for ADHD ...
Detailed Description
Trigeminal Nerve Stimulation (TNS), an FDA-approved, non-invasive minimal risk intervention approved for treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), administers a low amount of elect...
Eligibility Criteria
Inclusion
- 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;
- total score \>= 24 on 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT05374187
Start Date
September 1 2022
End Date
January 31 2026
Last Update
May 13 2025
Active Locations (2)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
Seattle Children's Hospital
Seattle, Washington, United States, 98105