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Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT01388530
Recruitment Status : Completed
First Posted : July 6, 2011
Results First Posted : April 11, 2016
Last Update Posted : April 11, 2016
Sponsor:
Collaborator:
NeuroSigma, Inc.
Information provided by (Responsible Party):
James McGough, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Attention-Deficit/Hyperactivity Disorder Device: EMS 7500 Digital Muscle Stimulator Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date : July 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. ADHD-IV Rating Scale (ADHD-RS) [ Time Frame: Baseline and Week 8. ]

    A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms.

    Scale ranges from 0 (best) to 54 (worst).

    Unit of Measure - units on a scale.

    Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS.



Secondary Outcome Measures :
  1. Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Week 8 ]

    A global measure of clinical improvement compared with baseline.

    A standard clinical trials rating scale with value from 1 (very much improved) to 7 (very much worse).

    Unit of measure - percentage improved based on CGI-I scores of 1 and 2 versus all others.


  2. Conners Global Index - Parent [ Time Frame: Baseline and Week 8. ]

    A standard, parent completed measure of ADHD symptoms.

    Scale range from 0 (best) to 27 (worst).

    Unit of Measure - units on a scale.

    Outcome value reflects change from baseline at endpoint (Week 8).


  3. Attention Network Task - Incongruent Reaction Time [ Time Frame: Baseline and Week 8. ]

    Laboratory measure of response inhibition. The measure assessed the reaction time in milliseconds (ms) using the Attention Network Task (ANT), which is a computerized test designed to evaluate the efficiency of an attention network.

    Outcome measure represents a change from Baseline at Week 8 for the ANT - Incongruent reaction time. Lower reaction time is consider a better outcome.




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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female youth age 9 to 14 years with Diagnostic and Statistical Manuel -IV (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-Rating Scale (ADHD-RS)S
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388530


Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
NeuroSigma, Inc.
Investigators
Principal Investigator: James J McGough, M.D. University of California, Los Angeles

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
First Posted: July 6, 2011    Key Record Dates
Results First Posted: April 11, 2016
Last Update Posted: April 11, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms