Treatment Parameters for the Empower Neuromodulation System (ENS) (AUD1)

October 26, 2020 updated by: Theranova, L.L.C.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • TheraNova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TENS treatment arm
This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.
Device: TENS
Transcutaneous electrical nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 hours, length of study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theranova, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2019

Primary Completion (ACTUAL)

March 13, 2019

Study Completion (ACTUAL)

March 13, 2019

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (ACTUAL)

January 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD-12-1154

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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