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出境医 / 临床实验 / Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Device: Empower Neuromodulation System Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : March 26, 2020
Actual Study Completion Date : March 26, 2020
Arms and Interventions
Arm Intervention/treatment
No Intervention: Baseline
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.
Experimental: Active treatment
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.
Device: Empower Neuromodulation System
Transcutaneous electrical nerve stimulation

Outcome Measures
Primary Outcome Measures :
  1. Change in Mean Number of Alcoholic Drinks Consumed Per Day [ Time Frame: Baseline week and Week 2 of the treatment phase ]
    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.

  2. Number of Participants With Adverse Events [ Time Frame: Through study completion, an average of 3 weeks ]
    Safety assessment via device-related adverse events


Secondary Outcome Measures :
  1. Decrease in Mean Alcohol Craving Intensity [ Time Frame: Baseline week and Week 2 of the treatment phase ]
    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.

  2. Usability [ Time Frame: Study completion, at approximately 3 weeks ]
    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").


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
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United States, California
NCIRE
San Francisco, California, United States, 94121
Sponsors and Collaborators
Theranova, L.L.C.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Northern California Institute of Research and Education
Investigators
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Study Director: Michael Jaasma Theranova, L.L.C.
Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 12, 2019
Results First Submitted Date  ICMJE September 25, 2020
Results First Posted Date  ICMJE October 20, 2020
Last Update Posted Date November 18, 2020
Actual Study Start Date  ICMJE May 20, 2019
Actual Primary Completion Date March 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
  • Change in Mean Number of Alcoholic Drinks Consumed Per Day [ Time Frame: Baseline week and Week 2 of the treatment phase ]
    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 [ Time Frame: Through study completion, an average of 3 weeks ]
    Safety assessment via device-related adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • OCDS score [ Time Frame: 3 weeks ]
    Change in the obsessive compulsive drinking scale (OCDS) score
  • Adverse Events [ Time Frame: 3 weeks ]
    Safety assessment via device-related adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
  • Decrease in Mean Alcohol Craving Intensity [ Time Frame: Baseline week and Week 2 of the treatment phase ]
    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 [ Time Frame: Study completion, at approximately 3 weeks ]
    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").
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
Alcohol craving score [ Time Frame: 3 weeks ]
Alcohol craving intensity via visual-analog scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Evaluation of the Empower Neuromodulation System in AUD Patients
Official Title  ICMJE Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE Device: Empower Neuromodulation System
Transcutaneous electrical nerve stimulation
Study Arms  ICMJE
  • No Intervention: Baseline
    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.
  • Experimental: Active treatment
    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: Device: Empower Neuromodulation System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2020)
25
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2019)
50
Actual Study Completion Date  ICMJE March 26, 2020
Actual Primary Completion Date March 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983317
Other Study ID Numbers  ICMJE CRD-12-1176-01
R43AA027188-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Theranova, L.L.C.
Study Sponsor  ICMJE Theranova, L.L.C.
Collaborators  ICMJE
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Northern California Institute of Research and Education
Investigators  ICMJE
Study Director: Michael Jaasma Theranova, L.L.C.
PRS Account Theranova, L.L.C.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP