Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

This study is currently recruiting participants.

Verified October 2012 by University of California, Los Angeles

Sponsor:

Collaborator:

NeuroSigma, Inc.

Information provided by (Responsible Party):

James McGough, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT01388530

First received: June 24, 2011

Last updated: October 18, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 24, 2011

Last Updated Date

October 18, 2012

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

ADHD-IV Rating Scale (ADHD-RS) [ Time Frame: Change from screening, baseline, week 4, and week 8 visits. ] [ Designated as safety issue: No ]

A standard, frequently used, clinician completed measure of DSM-IV ADHD symptoms.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01388530 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Weeks 1 through 8 ] [ Designated as safety issue: No ]
A global measure of clinical improvement compared with baseline.
Conners Global Index - parent [ Time Frame: Change from baseline and weekly visits. ] [ Designated as safety issue: No ]
A standard, parent completed measure of ADHD symptoms.
Conners Global Index - teacher. [ Time Frame: Change from baseline, week 4, and week 8 visits. ] [ Designated as safety issue: No ]
A standard teacher report form of ADHD symptoms.

Original Secondary Outcome Measures ^ICMJE

CGI-Improvement [ Time Frame: Weeks 1 through 8 ] [ Designated as safety issue: No ]
A global measure of clinical improvement compared with baseline.
Conners Global Index - parent [ Time Frame: Change from baseline and weekly visits. ] [ Designated as safety issue: No ]
A standard, parent completed measure of ADHD symptoms.
Conners Global Index - teacher. [ Time Frame: Change from baseline, week 4, and week 8 visits. ] [ Designated as safety issue: No ]
A standard teacher report form of ADHD symptoms.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 0

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Attention-Deficit/Hyperactivity Disorder

Intervention ^ICMJE

Device: EMS 7500 Digital Muscle Stimulator

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

Study Arm (s)

Experimental: trigeminal nerve stimulation

Open label treatment with trigeminal nerve stimulation in an 8-week trial.

Intervention: Device: EMS 7500 Digital Muscle Stimulator

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

male and female youth age 9 to 14 years with DSM-IV ADHD, combined subtype as determined by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) and clinical interview
minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-RS
Clinical Global Impression- Severity (CGI-S) score at baseline
no current medications with central nervous system (CNS) affects
parents able and willing to monitor proper use of the stimulation device and complete all required rating scales.

Exclusion Criteria:

impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator; 2) current diagnosis of pervasive developmental disorder or major depression.
history of lifetime psychosis or mania
current suicidality
history of seizure disorder, tic disorder, or head injury with loss of consciousness.

Gender

Both

Ages

9 Years to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: James J. McGough, M.D.

310-794-7841

jmcgough@mednet.ucla.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01388530

Other Study ID Numbers ^ICMJE

UCLA-TNS/ADHD

Has Data Monitoring Committee

Responsible Party

James McGough, University of California, Los Angeles

Study Sponsor ^ICMJE

University of California, Los Angeles

Collaborators ^ICMJE

NeuroSigma, Inc.

Investigators ^ICMJE

Not Provided

Information Provided By

University of California, Los Angeles

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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