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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
  Purpose

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.


Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder
 Device: EMS 7500 Digital Muscle Stimulator
 Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: trigeminal nerve stimulation
Open label treatment with trigeminal nerve stimulation in an 8-week trial.
 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.

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388530

Contacts
Contact: James J. McGough, M.D. 310-794-7841 jmcgough@mednet.ucla.edu

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: James J McGough, M.D.            
Sub-Investigator: Ian Cook, M.D.            
Sponsors and Collaborators
University of California, Los Angeles
NeuroSigma, Inc.
  More Information

No publications provided

Responsible Party: James McGough, Professor of Clinical Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01388530     History of Changes
Other Study ID Numbers: UCLA-TNS/ADHD
Study First Received: June 24, 2011
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013