Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

Study Overview
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Brief Summary
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This study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (AUD). This is a pilot investigation in which all participants will receive the active treatment.

Detailed Description
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Alcohol use disorder (AUD) is a major public health concern, affecting over 16 million Americans. Peripheral nerve stimulation via acupuncture has been shown to directly decrease alcohol craving and self-administration. TheraNova has developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of AUD. In this study, we will conduct a cross-over, home-use study in participants with AUD. Participants will have a one-week control period with no treatment followed by two weeks of twice daily treatment with the Empower device. We will evaluate endpoints for safety and effectiveness.

Official Title
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Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Device: Empower Neuromodulation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is male or female ≥ 21 year of age at Visit 1 Has a current diagnosis of alcohol use disorder per DSM-5 by clinician assessment Endorses Criterion 4 in DSM-5 Has a desire to maintain abstinence or, if not abstinent, a desire to reduce or quit alcohol use Has a breath alcohol concentration of 0.00% at enrollment Is able to provide informed consent Is able to understand spoken and written English Is capable and willing to follow all study-related procedures Exclusion Criteria: Has been diagnosed with unstable psychosis, epilepsy, peripheral neuropathy, or nerve damage Requires acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD) 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 an electrically conductive metal object (e.g. jewelry) that cannot be removed from the palm and will directly contact the gel electrodes of the Empower Neuromodulation System Will not, for the duration of the participation in the study, have a living situation that provides regular access to an electrical outlet. Is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study Has used an investigational drug/device therapy within the past 4 weeks Is deemed unsuitable for enrollment in the study by the PI

Ages Eligible for Study
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Minimum Age: 21 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
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants will have a one-week control period with no treatment followed by two weeks of twice daily Empower treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline<br>For the first week of the study, participants will not administer treatment with the Empower device. Participants will complete surveys to establish baseline values for each participant. | |
| Experimental: Active treatment<br>Participants will self-administer treatment with the Empower device two times daily for two weeks. Participants will complete surveys over the two-week period to evaluate the effects of the Empower treatment. | Device: Empower Neuromodulation System<br>* Transcutaneous electrical nerve stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Number of Alcoholic Drinks Consumed Per Day | Change in the self-reported average daily consumption over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase. | Baseline week and Week 2 of the treatment phase | 
| Number of Participants With Adverse Events | Safety assessment via device-related adverse events | Through study completion, an average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Mean Alcohol Craving Intensity | Change in self-reported average alcohol craving intensity via 100-mm visual-analog scale (VAS). The VAS has a minimum score of 0 (no craving) and a maximum score of 100 (severe craving). We compared the average daily craving intensity over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase. | Baseline week and Week 2 of the treatment phase | 
| Usability | System Usability Scale (SUS) survey to evaluate usability. The SUS is a 10-item self-report survey (each question is answered on a 5-point Likert scale) which measures usability. An SUS score of 68 is considered average, whereas SUS=80 is the 90th percentile score (excellent). | Study completion, at approximately 3 weeks |