Treatment Parameters for the Empower Neuromodulation System (ENS)

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TheraNova

San Francisco, California, 94107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS

Device

Transcutaneous electrical nerve stimulation

Primary outcomes

Number of Participants Who Experienced Effective Electrode Placement

Time frame: 2 hours, length of study visit

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).

Sponsors and collaborators

Lead sponsor

Theranova, L.L.C.

Industry

Registry information

Official study title

Study to Optimize and Validate the Treatment Parameters for the Empower Neuromodulation System

Acronym: AUD1

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Jan 17, 2019
Registry last updated: Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed