CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 25 enrolled
Drug / intervention
EMS 7500 Digital Muscle Stimulatordevice
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/NCT01388530
NCT01388530Early Ph 1Completed
CompareCT.gov

An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

University of California, Los Angeles·interventional·Posted Jul 6, 2011·Updated Apr 11, 2016

In Brief

A Early Phase 1 clinical trial evaluating EMS 7500 Digital Muscle Stimulator for Attention-Deficit/Hyperactivity Disorder. Completed, enrolled 25 participants across 1 site.

Detailed Summary

This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention-Deficit/Hyperactivity Disorder
CountriesUnited States
CollaboratorsNeuroSigma, Inc.

Timeline

Early Ph 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 6, 2011
Enrollment StartJul 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.0 years ago

Interventions

EMS 7500 Digital Muscle Stimulatordevice

A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.