Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

Study Overview
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Brief Summary
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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.

Official Title
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An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

Conditions
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Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
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* Device: EMS 7500 Digital Muscle Stimulator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trigeminal nerve stimulation<br>Open label treatment with trigeminal nerve stimulation in an 8-week trial. | Device: EMS 7500 Digital Muscle Stimulator<br>* A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.<br>|

What is the study measuring?
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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. |