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ACTIVE NOT RECRUITING
NCT05374187
NA

Efficacy of Trigeminal Nerve Stimulation for ADHD

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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