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Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
NeuroSigma, Inc.
Information provided by (Responsible Party):
James McGough, University of California, Los Angeles Identifier:
First received: June 24, 2011
Last updated: March 23, 2016
Last verified: March 2016
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
Early Phase 1

Study Type: Interventional
Study Design: 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:

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

Primary Outcome Measures:
  • 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:
  • 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.

  • 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).

  • 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.

Enrollment: 25
Study Start Date: July 2011
Study Completion Date: December 2012
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.


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

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.
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Please refer to this study by its identifier: NCT01388530

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

Responsible Party: James McGough, Professor of Clinical Psychiatry, University of California, Los Angeles Identifier: NCT01388530     History of Changes
Other Study ID Numbers: UCLA-TNS/ADHD
Study First Received: June 24, 2011
Results First Received: January 26, 2013
Last Updated: March 23, 2016

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 23, 2017