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.

Study Overview

• Status: Completed
• Conditions: Attention-Deficit/Hyperactivity Disorder
• Intervention / Treatment: Device: EMS 7500 Digital Muscle Stimulator

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 8.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 8
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).	Baseline and 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.	Baseline and Week 8.

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: NeuroSigma, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 24, 2011
• First Submitted That Met QC Criteria: July 1, 2011
• First Posted (Estimate): July 6, 2011

Study Record Updates

• Last Update Posted (Estimate): April 11, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: UCLA-TNS/ADHD