Treatment Parameters for the Empower Neuromodulation System (ENS)
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 3/16/2019 |
| Start Date: | January 15, 2019 |
| End Date: | March 13, 2019 |
Study to Optimize and Validate the Treatment Parameters for the Empower Neuromodulation System
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.
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.
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
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