N/A
Completed N=17
Treatment Parameters for the Empower Neuromodulation System (ENS)
Source: ClinicalTrials.gov NCT03807544 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Number of Participants Who Experienced Effective Electrode Placement — 17; 17 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Effective Electrode Placement |
17; 17 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03807544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.