| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||
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* 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 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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