Treatment Parameters for the Empower Neuromodulation System (ENS)

Completed · Not applicable

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT03807544

Run by

Theranova, L.L.C.

People needed

17

Starts

2019-01-15

Expected to finish

2019-03-13

Last updated by the study team

2020-11-17

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• TheraNova — San Francisco, California, United States

Full record on ClinicalTrials.gov

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