Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

Early Phase 1

Completed

• Conditions: Attention-Deficit/Hyperactivity Disorder
• Interventions: Device: EMS 7500 Digital Muscle Stimulator

• Registration Number: NCT01388530
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-06-24
• Study Start: 2011-07
• Study First Submitted QC: 2011-07-01
• Study First Posted: 2011-07-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-01-26
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-23
• Last Update Submitted: 2016-03-23
• Results First Posted: 2016-04-11
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
trigeminal nerve stimulation	EMS 7500 Digital Muscle Stimulator	Open label treatment with trigeminal nerve stimulation in an 8-week trial.

Primary Outcome Measures

Name	Time	Method
ADHD-IV Rating Scale (ADHD-RS)	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

Name	Time	Method
Conners Global Index - Parent	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).
Clinical Global Impression - Improvement (CGI-I)	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.
Attention Network Task - Incongruent Reaction Time	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.

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States