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Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

Primary Purpose

Attention-Deficit/Hyperactivity Disorder

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
EMS 7500 Digital Muscle Stimulator
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

trigeminal nerve stimulation

Arm Description

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

Outcomes

Primary Outcome Measures

ADHD-IV Rating Scale (ADHD-RS)
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)
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
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
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.

Full Information

First Posted
June 24, 2011
Last Updated
March 23, 2016
Sponsor
University of California, Los Angeles
Collaborators
NeuroSigma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01388530
Brief Title
Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
NeuroSigma, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
trigeminal nerve stimulation
Arm Type
Experimental
Arm Description
Open label treatment with trigeminal nerve stimulation in an 8-week trial.
Intervention Type
Device
Intervention Name(s)
EMS 7500 Digital Muscle Stimulator
Intervention Description
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 Measure Information:
Title
ADHD-IV Rating Scale (ADHD-RS)
Description
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.
Time Frame
Baseline and Week 8.
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Improvement (CGI-I)
Description
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.
Time Frame
Week 8
Title
Conners Global Index - Parent
Description
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).
Time Frame
Baseline and Week 8.
Title
Attention Network Task - Incongruent Reaction Time
Description
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.
Time Frame
Baseline and Week 8.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James J McGough, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

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