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Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empower Neuromodulation System
Sponsored by
Theranova, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • Is male or female ≥ 21 year of age at Visit 1
  • Has a current diagnosis of alcohol use disorder per DSM-5 by clinician assessment
  • Endorses Criterion 4 in DSM-5
  • Has a desire to maintain abstinence or, if not abstinent, a desire to reduce or quit alcohol use
  • Has a breath alcohol concentration of 0.00% at enrollment
  • Is able to provide informed consent
  • Is able to understand spoken and written English
  • Is capable and willing to follow all study-related procedures

Exclusion Criteria:

  • Has been diagnosed with unstable psychosis, epilepsy, peripheral neuropathy, or nerve damage
  • Requires acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD)
  • 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 an electrically conductive metal object (e.g. jewelry) that cannot be removed from the palm and will directly contact the gel electrodes of the Empower Neuromodulation System
  • Will not, for the duration of the participation in the study, have a living situation that provides regular access to an electrical outlet.
  • Is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
  • Has used an investigational drug/device therapy within the past 4 weeks
  • Is deemed unsuitable for enrollment in the study by the PI

Sites / Locations

  • NCIRE

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Baseline

Active treatment

Arm Description

For the first week of the study, participants will not administer treatment with the Empower device. Participants will complete surveys to establish baseline values for each participant.

Participants will self-administer treatment with the Empower device two times daily for two weeks. Participants will complete surveys over the two-week period to evaluate the effects of the Empower treatment.

Outcomes

Primary Outcome Measures

Change in Mean Number of Alcoholic Drinks Consumed Per Day
Change in the self-reported average daily consumption over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase.
Number of Participants With Adverse Events
Safety assessment via device-related adverse events

Secondary Outcome Measures

Decrease in Mean Alcohol Craving Intensity
Change in self-reported average alcohol craving intensity via 100-mm visual-analog scale (VAS). The VAS has a minimum score of 0 (no craving) and a maximum score of 100 (severe craving). We compared the average daily craving intensity over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase.
Usability
System Usability Scale (SUS) survey to evaluate usability. The SUS is a 10-item self-report survey (each question is answered on a 5-point Likert scale) which measures usability. An SUS score of 68 is considered average, whereas SUS=80 is the 90th percentile score ("excellent").

Full Information

First Posted
June 10, 2019
Last Updated
November 12, 2020
Sponsor
Theranova, L.L.C.
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Northern California Institute of Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT03983317
Brief Title
Pilot Evaluation of the Empower Neuromodulation System in AUD Patients
Official Title
Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
March 26, 2020 (Actual)
Study Completion Date
March 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theranova, L.L.C.
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Northern California Institute of Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (AUD). This is a pilot investigation in which all participants will receive the active treatment.
Detailed Description
Alcohol use disorder (AUD) is a major public health concern, affecting over 16 million Americans. Peripheral nerve stimulation via acupuncture has been shown to directly decrease alcohol craving and self-administration. TheraNova has developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of AUD. In this study, we will conduct a cross-over, home-use study in participants with AUD. Participants will have a one-week control period with no treatment followed by two weeks of twice daily treatment with the Empower device. We will evaluate endpoints for safety and effectiveness.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All participants will have a one-week control period with no treatment followed by two weeks of twice daily Empower treatment.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline
Arm Type
No Intervention
Arm Description
For the first week of the study, participants will not administer treatment with the Empower device. Participants will complete surveys to establish baseline values for each participant.
Arm Title
Active treatment
Arm Type
Experimental
Arm Description
Participants will self-administer treatment with the Empower device two times daily for two weeks. Participants will complete surveys over the two-week period to evaluate the effects of the Empower treatment.
Intervention Type
Device
Intervention Name(s)
Empower Neuromodulation System
Intervention Description
Transcutaneous electrical nerve stimulation
Primary Outcome Measure Information:
Title
Change in Mean Number of Alcoholic Drinks Consumed Per Day
Description
Change in the self-reported average daily consumption over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase.
Time Frame
Baseline week and Week 2 of the treatment phase
Title
Number of Participants With Adverse Events
Description
Safety assessment via device-related adverse events
Time Frame
Through study completion, an average of 3 weeks
Secondary Outcome Measure Information:
Title
Decrease in Mean Alcohol Craving Intensity
Description
Change in self-reported average alcohol craving intensity via 100-mm visual-analog scale (VAS). The VAS has a minimum score of 0 (no craving) and a maximum score of 100 (severe craving). We compared the average daily craving intensity over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase.
Time Frame
Baseline week and Week 2 of the treatment phase
Title
Usability
Description
System Usability Scale (SUS) survey to evaluate usability. The SUS is a 10-item self-report survey (each question is answered on a 5-point Likert scale) which measures usability. An SUS score of 68 is considered average, whereas SUS=80 is the 90th percentile score ("excellent").
Time Frame
Study completion, at approximately 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is male or female ≥ 21 year of age at Visit 1 Has a current diagnosis of alcohol use disorder per DSM-5 by clinician assessment Endorses Criterion 4 in DSM-5 Has a desire to maintain abstinence or, if not abstinent, a desire to reduce or quit alcohol use Has a breath alcohol concentration of 0.00% at enrollment Is able to provide informed consent Is able to understand spoken and written English Is capable and willing to follow all study-related procedures Exclusion Criteria: Has been diagnosed with unstable psychosis, epilepsy, peripheral neuropathy, or nerve damage Requires acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD) 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 an electrically conductive metal object (e.g. jewelry) that cannot be removed from the palm and will directly contact the gel electrodes of the Empower Neuromodulation System Will not, for the duration of the participation in the study, have a living situation that provides regular access to an electrical outlet. Is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study Has used an investigational drug/device therapy within the past 4 weeks Is deemed unsuitable for enrollment in the study by the PI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Jaasma
Organizational Affiliation
Theranova, L.L.C.
Official's Role
Study Director
Facility Information:
Facility Name
NCIRE
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

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