Status:
COMPLETED
Treatment Parameters for the Empower Neuromodulation System (ENS)
Lead Sponsor:
Theranova, L.L.C.
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-75 years
Phase:
NA
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 conductio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03807544
Start Date
January 15 2019
End Date
March 13 2019
Last Update
November 17 2020
Active Locations (1)
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1
TheraNova
San Francisco, California, United States, 94107