Treatment Parameters for the Empower Neuromodulation System (ENS)

Study Overview
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Brief Summary
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The subject will be administered a treatment at a treatment location and then be asked if he/she believes it is the active treatment, sham treatment, or does not know. A clinical-grade nerve conduction assessment system will be used both to provide electrical stimulation at four locations to record peripheral responses. The subject will self-administer two treatment sessions at two active treatment sites.

Official Title
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Study to Optimize and Validate the Treatment Parameters for the Empower Neuromodulation System

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Device: TENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is 21-75 years old Can provide informed consent Currently has a stable living situation Had one heavy drinking week (>7 drinks/week for women; >14 drinks/week for men) over the past 6 months Has a breath alcohol concentration of 0.00% at enrollment Is willing to follow all study procedures Exclusion Criteria: Has been diagnosed with schizophrenia, epilepsy, peripheral neuropathy, or nerve damage Has implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant) Has a tattoo or conductive, ferromagnetic, or other magnetic-sensitive metals that cannot be removed from the hand, wrist, or biceps Is currently pregnant or breastfeeding Has a bleeding disorder, a history of deep vein thrombosis, or is on anticoagulation drugs Has used an investigational drug/device therapy within the past 4 weeks Is deemed unsuitable for enrollment in study by the PI

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: TENS treatment arm<br>This study is a usability study, where all subjects will receive the same experimental treatment for their single visit. | Device: TENS<br>* Transcutaneous electrical nerve stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced Effective Electrode Placement | Compare two active treatment electrode locations to evaluate the effect of electrode placement on the appearance of sensory nerve action potentials, including tingling sensation, along the stimulated nerve using electromyography (EMG). | 2 hours, length of study visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AUD, TENS