NCT05374187View on ClinicalTrials.gov

Efficacy of Trigeminal Nerve Stimulation for ADHD

NARecruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Attention-Deficit Hyperactivity Disorder
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.

Trial Locations (2)

90095

RECRUITING

University of California, Los Angeles, Los Angeles

98105

RECRUITING

Seattle Children's Hospital, Seattle

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

University of California, Los Angeles

OTHER