Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

TheraNova

Status: Completed

Conditions: Alcohol Use Disorder

Treatments: Device: Empower Neuromodulation System

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03983317

R43AA027188-01 (U.S. NIH Grant/Contract)

CRD-12-1176-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Baseline

No Intervention group

Description:

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.

Active treatment

Experimental group

Description:

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.

Treatment:

Device: Empower Neuromodulation System