Status:
COMPLETED
Four-week Open-trial Extension TNS for ADHD
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
8-12 years
Phase:
NA
Brief Summary
The purpose of this study will be to offer children previously randomized to sham treatment in a 5-week double-blind sham controlled study of Trigeminal Nerve Stimulation for ADHD (NCT02155608) an opp...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- currently requiring any medication with CNS effects
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03870737
Start Date
December 1 2014
End Date
May 30 2018
Last Update
May 29 2019
Active Locations (1)
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1
UCLA Semel Institute
Los Angeles, California, United States, 90095