Pilot Evaluation of the Empower Neuromodulation System in AUD Patients
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|ClinicalTrials.gov Identifier: NCT03983317|
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Device: Empower Neuromodulation System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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)|
|Official Title:||Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
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
- Obsessive compulsive drinking scale (OCDS) score [ Time Frame: 3 weeks ]Change in the obsessive compulsive drinking scale (OCDS) score. The OCDS is a 14-item, self-report questionnaire that measures alcohol-related craving. The OCDS has a minimum score of 0 (no craving) and a maximum score of 56 (severe craving).
- Adverse events [ Time Frame: 3 weeks ]Safety assessment via device-related adverse events
- Alcohol craving score [ Time Frame: 3 weeks ]Change in 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983317
|Contact: Michael Vice Presidentfirstname.lastname@example.org|
|United States, California|
|NCIRE||Not yet recruiting|
|San Francisco, California, United States, 94121|
|Contact: Brooke Clinical Research Coordinator 415-221-4810 ext 24495|
|Principal Investigator: Steven Batki, MD|
|Study Director:||Michael Jaasma||Theranova, L.L.C.|