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

Primary Purpose

Alcohol Use Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TENS

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring AUD, TENS

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

TheraNova

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TENS treatment arm

Arm Description

This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03807544

First Posted

January 4, 2019

Last Updated

October 26, 2020

Sponsor

Theranova, L.L.C.

1. Study Identification

Unique Protocol Identification Number

NCT03807544

Brief Title

Treatment Parameters for the Empower Neuromodulation System (ENS)

Acronym

AUD1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

January 15, 2019 (Actual)

Primary Completion Date

March 13, 2019 (Actual)

Study Completion Date

March 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theranova, L.L.C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

AUD, TENS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TENS treatment arm

Arm Type

Experimental

Arm Description

This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.

Intervention Type

Device

Intervention Name(s)

TENS

Intervention Description

Transcutaneous electrical nerve stimulation

Primary Outcome Measure Information:

Title

Number of Participants Who Experienced Effective Electrode Placement

Description

Time Frame

2 hours, length of study visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

TheraNova

City

San Francisco

State/Province

California

ZIP/Postal Code

94107

Country

United States

12. IPD Sharing Statement

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Treatment Parameters for the Empower Neuromodulation System (ENS)

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