Four-week Open-trial Extension TNS for ADHD
Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Mar 8, 2019
Trial Information
Current as of May 20, 2025
Completed
Keywords
ClinConnect Summary
This study will enroll participants with ADHD who previously participated in a 5-week sham-controlled investigation of Trigeminal Nerve Stimulation as a treatment for ADHD, and who were randomized to the sham condition.
In the double-blind trial (NCT02155608), children ages 8-12 years undergo study screening and if eligible begin 4 weeks nightly treatment with active or sham TNS administered nightly during sleep. At the conclusion of the 4-week trial, all interventions (both active and sham TNS) are discontinued with blinding remaining in place for an additional week to assess possible res...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • male and female children ages 8-12 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
- • participated in a previous randomized, double-blind, sham-controlled trial of TNS for ADHD, and randomized to the sham condition.
- • parents able and willing to monitor proper use of the TNS device and complete all required rating scales
- • parent and participants able to compete study rating scales and other measures in English
- Exclusion Criteria:
- • currently requiring any medication with CNS effects
About University Of California, Los Angeles
The University of California, Los Angeles (UCLA) is a prestigious academic institution renowned for its commitment to research and innovation in the biomedical field. As a clinical trial sponsor, UCLA leverages its cutting-edge facilities, expert faculty, and collaborative environment to advance medical knowledge and improve patient care. The university is dedicated to conducting rigorous clinical research that adheres to the highest ethical standards, aiming to translate scientific discoveries into effective therapies and interventions. Through its diverse array of clinical trials, UCLA seeks to address critical health challenges while fostering the development of future healthcare leaders.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Patients applied
Trial Officials
James J. McGough, M.D.
Principal Investigator
University of California, Los Angeles
Sandra K. Loo, Ph.D.
Principal Investigator
University of California, Los Angeles
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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