Condition or disease | Intervention/treatment | Phase |
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Alcohol Use Disorder | Device: Empower Neuromodulation System | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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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.
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Device: Empower Neuromodulation System
Transcutaneous electrical nerve stimulation
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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
NCIRE | |
San Francisco, California, United States, 94121 |
Study Director: | Michael Jaasma | Theranova, L.L.C. |
Tracking Information | |||||||||
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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 |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Alcohol craving score [ Time Frame: 3 weeks ] Alcohol craving intensity via visual-analog scale
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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 |
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Condition ICMJE | Alcohol Use Disorder | ||||||||
Intervention ICMJE | Device: Empower Neuromodulation System
Transcutaneous electrical nerve stimulation
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Actual Enrollment ICMJE |
25 | ||||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Theranova, L.L.C. | ||||||||
Study Sponsor ICMJE | Theranova, L.L.C. | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |