Treatment Parameters for the Empower Neuromodulation System (ENS)

Theranova, L.L.C.17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alcohol Use Disorder

Interventions

TENSDEVICE

Transcutaneous electrical nerve stimulation

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

TheraNova

San Francisco, California, United States

Outcomes

Primary Outcomes

Number of Participants Who Experienced Effective Electrode Placement

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).

Time frame: 2 hours, length of study visit

Data from ClinicalTrials.gov

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