Treatment Parameters for the Empower Neuromodulation System (ENS)
Not Applicable
Completed
- Conditions
- Alcohol Use Disorder
- Interventions
- Device: TENS
- Registration Number
- NCT03807544
- Lead Sponsor
- Theranova, L.L.C.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TENS treatment arm TENS This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced Effective Electrode Placement 2 hours, length of study visit 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
TheraNova
🇺🇸San Francisco, California, United States