Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
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: March 23, 2016
Last verified: March 2016

June 24, 2011
March 23, 2016
July 2011
December 2012   (final data collection date for primary outcome measure)
ADHD-IV Rating Scale (ADHD-RS) [ Time Frame: Baseline and Week 8. ] [ Designated as safety issue: No ]

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.

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.
Complete list of historical versions of study NCT01388530 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

    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.

  • 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.
Not Provided
Not Provided
 
Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
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.
Not Provided
Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention-Deficit/Hyperactivity Disorder
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.
Experimental: trigeminal nerve stimulation
Open label treatment with trigeminal nerve stimulation in an 8-week trial.
Intervention: Device: EMS 7500 Digital Muscle Stimulator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
7 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01388530
UCLA-TNS/ADHD
No
Not Provided
Not Provided
James McGough, University of California, Los Angeles
University of California, Los Angeles
NeuroSigma, Inc.
Principal Investigator: James J McGough, M.D. University of California, Los Angeles
University of California, Los Angeles
March 2016

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