CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Active TNSdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03870737
NCT03870737N/ACompleted
CompareCT.gov

Four-week Open-trial Extension Study of Trigeminal Nerve Stimulation (TNS) for Youth Previously Randomized to Sham in a Double-Blind Trial

University of California, Los Angeles·interventional·Posted Mar 12, 2019·Updated May 29, 2019

In Brief

A clinical study evaluating Active TNS for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 22 participants across 1 site.

Detailed 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 opportunity to receive 4-weeks active TNS treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder (ADHD)
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 12, 2019
Enrollment StartDec 1, 2014
Primary CompletionMay 30, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.3 years ago

Interventions

Active TNSdevice

Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study.