Clinical Research Directory
Browse clinical research sites, groups, and studies.
Efficacy of Trigeminal Nerve Stimulation for ADHD
Sponsor: University of California, Los Angeles
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 in children ages 7-12 years old (N=180). Study hypotheses address potential differences in ADHD symptoms over 4 weeks treatment with active vs. sham TNS in an expanded multi-site investigation; whether resting state fronto-parietal connectivity mediates TNS impact on ADHD symptoms; if changes in fronto-parietal activation, as measured by electroencephalography (EEG), predict TNS-related treatment outcomes; and whether a baseline cognitive profile similarly predicts response to TNS therapy.
Official title: Efficacy of External Trigeminal Nerve Stimulation for Treatment of ADHD
Key Details
Gender
All
Age Range
7 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2022-09-01
Completion Date
2026-05-31
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Active eTNS
Participants will receive active trigeminal nerve stimulation (eTNS) administered by the Monarch eTNS system nightly during sleep for 4 weeks. Participants deemed to be positive responders to blinded active treatment will be invited to continue open nightly eTNS in a 12 month extension period.
Sham eTNS
Participants will receive sham trigeminal nerve stimulation (eTNS) administered by the Monarch eTNS system nightly during sleep for 4 weeks. At conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open active eTNS treatment. Participants deemed to be positive responders to open active treatment will be invited to continue open nightly eTNS in a 12 month extension period.
Locations (2)
University of California, Los Angeles
Los Angeles, California, United States
Seattle Children's Hospital
Seattle, Washington, United States