CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Active eTNS +1 moredevice
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/NCT02155608
NCT02155608N/ACompleted
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Developmental Pilot Study of External Trigeminal Nerve Stimulation for ADHD

University of California, Los Angeles·interventional·Posted Jun 4, 2014·Updated Jul 2, 2019

In Brief

A clinical study evaluating Active eTNS and Sham eTNS for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 62 participants across 1 site.

Detailed Summary

The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD). Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS treatment on ADHD symptoms, measures of executive function, electroencephalography (EEG) profiles, other dimensional measures of height, weight, mood, anxiety, and sleep, and side effect profiles.

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 PostedJun 4, 2014
Enrollment StartApr 1, 2015
Primary CompletionMay 30, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.1 years ago

Interventions

Active eTNSdevice

Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period.

Sham eTNSdevice

Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period.