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| ID | Type | Description | Link |
|---|---|---|---|
| R43AA027188-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Northern California Institute of Research and Education | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline | No Intervention | 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. | |
| Active treatment | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empower Neuromodulation System | Device | Transcutaneous electrical nerve stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline week and Week 2 of the treatment phase |
| Number of Participants With Adverse Events | Safety assessment via device-related adverse events | Through study completion, an average of 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline week and Week 2 of the treatment phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Jaasma | Theranova, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCIRE | San Francisco | California | 94121 | United States |
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Participants completed the Baseline Phase first, so participants who did not complete the Baseline Phase did not start the Treatment Phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | For the first week of the study, participants did not administer treatment with the Empower device. In this one-week Baseline Phase, participants only completed surveys to establish baseline values. In the final two weeks of the study, participants self-administered treatment with the Empower device two times daily. Participants completed surveys over the two-week period to evaluate the effects of the Empower treatment. Empower Neuromodulation System: Transcutaneous electrical nerve stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | For the first week of the study, participants did not administer treatment with the Empower device. In this one-week Baseline Phase, participants only completed surveys to establish baseline values. In the final two weeks of the study, participants self-administered treatment with the Empower device two times daily. Participants completed surveys over the two-week period to evaluate the effects of the Empower treatment. Empower Neuromodulation System: Transcutaneous electrical nerve stimulation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed the study | Posted | Mean | Standard Deviation | Change in alcoholic drinks per day | Baseline week and Week 2 of the treatment phase |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment (AEs Occurred During the Two-week Treatment Phase) | For the first week of the study, participants did not administer treatment with the Empower device. In this one-week Baseline Phase, participants only completed surveys to establish baseline values. In the final two weeks of the study, participants self-administered treatment with the Empower device two times daily. Participants completed surveys over the two-week period to evaluate the effects of the Empower treatment. Empower Neuromodulation System: Transcutaneous electrical nerve stimulation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment | Determined to not be device-related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Research and Development | TheraNova, LLC | 415-926-8616 | clinicalstudy@theranova.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2018 | Sep 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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All participants will have a one-week control period with no treatment followed by two weeks of twice daily Empower treatment.
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| 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"). | Study completion, at approximately 3 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Participants With Adverse Events | Safety assessment via device-related adverse events | All participants | Posted | Count of Participants | Participants | Through study completion, an average of 3 weeks |
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|
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| Secondary | 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. | Participants who completed the study | Posted | Mean | Standard Deviation | Change in units on 100-mm VAS scale | Baseline week and Week 2 of the treatment phase |
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| Secondary | 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"). | Participants who completed the study. | Posted | Mean | Standard Deviation | Score on the SUS survey scale | Study completion, at approximately 3 weeks |
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| 0 |
| 25 |
| 2 |
| 25 |
| 0 |
| 25 |
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| Head injury | General disorders | Non-systematic Assessment | Slip/fall with head injury. Determined to not be device-related |
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