Treatment Parameters for the Empower Neuromodulation System (ENS) (AUD1)

TheraNova

Status: Completed

Conditions: Alcohol Use Disorder

Treatments: Device: TENS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03807544

CRD-12-1154

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Is 21-75 years old
2. Can provide informed consent
3. Currently has a stable living situation
4. Had one heavy drinking week (>7 drinks/week for women; >14 drinks/week for men) over the past 6 months
5. Has a breath alcohol concentration of 0.00% at enrollment
6. Is willing to follow all study procedures

Exclusion criteria

1. Has been diagnosed with schizophrenia, epilepsy, peripheral neuropathy, or nerve damage
2. 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)
3. Has a tattoo or conductive, ferromagnetic, or other magnetic-sensitive metals that cannot be removed from the hand, wrist, or biceps
4. Is currently pregnant or breastfeeding
5. Has a bleeding disorder, a history of deep vein thrombosis, or is on anticoagulation drugs
6. Has used an investigational drug/device therapy within the past 4 weeks
7. Is deemed unsuitable for enrollment in study by the PI

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

TENS treatment arm

Experimental group

Description:

This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.

Treatment:

Device: TENS