Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2023-12-01
2025-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active Treatment
The Active Treatment will use a functional Stimulator system.
Empower Neuromodulation System
The Empower Neuromodulation System is designed to provide transcutaneous stimulation to the branches of a spinal nerve. The system comprised of three key components: (A) The Stimulator, (B) the Empower smartphone app, and (C) the Gel Patch. The smartphone application is used to coordinate treatment and record participant responses.
Sham Treatment
The Sham Treatment (Placebo) will use a functional Stimulator system, but will provide a treatment in a location that is believed to have no benefit or harm to the subject.
Empower Neuromodulation System
The Empower Neuromodulation System is designed to provide transcutaneous stimulation to the branches of a spinal nerve. The system comprised of three key components: (A) The Stimulator, (B) the Empower smartphone app, and (C) the Gel Patch. The smartphone application is used to coordinate treatment and record participant responses.
Interventions
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Empower Neuromodulation System
The Empower Neuromodulation System is designed to provide transcutaneous stimulation to the branches of a spinal nerve. The system comprised of three key components: (A) The Stimulator, (B) the Empower smartphone app, and (C) the Gel Patch. The smartphone application is used to coordinate treatment and record participant responses.
Eligibility Criteria
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Inclusion Criteria
* Individual has a current diagnosis of alcohol use disorder per DSM-5 via M.I.N.I. assessment by clinician
* Individual has a desire to reduce or quit alcohol use
* Based on the 28-day TLFB at enrollment, individual has an average daily alcohol consumption in the WHO risk levels of moderate, high, or very high (men: ≥2.91 drinks/day; women: ≥1.41 drinks/day)
* Individual has a breath alcohol concentration of 0.02% or less at enrollment
* Individual has a negative urine pregnancy test at screening (females of childbearing age only)
* Individual is able to provide informed consent
* Individual is capable and willing to follow all study-related procedures
Exclusion Criteria
* Individual has a current, unstable psychiatric disorder per DSM-5 via M.I.N.I. assessment that is clinically significant enough to preclude study participation per the judgment of the study site PIs
* Individual has been diagnosed with a neurodegenerative disease, including Parkinson's disease, dementia, and Alzheimer's disease
* Individual has a current substance use disorder (SUD) diagnosis other than alcohol, nicotine, or cannabis per DSM-5 via M.I.N.I. assessment by clinician
* Individual requires acute medical detoxification from alcohol per based on a score of 12 or more on the Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-Ar)
* Individual is taking or plans to start taking an AUD pharmacotherapy during the study
* Individual has had a change in AUD pharmacotherapy in the past 4 weeks
* Individual has initiated or discontinued SUD psychotherapy in the past 4 weeks, has had a change in SUD psychotherapy modality in the past 4 weeks, or expects to initiate, discontinue, or change psychotherapy modality during the study
* Individual has an active implant and/or an implanted electrical or neurostimulator device (e.g., pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
* Individual is currently using, or has used in the past 3 months, transcutaneous electrical nerve stimulation (TENS) in the upper extremities
* Individual is currently receiving, or has received in the past 3 months, acupuncture, or acupressure in the upper extremities
* Individual has an electrically conductive metal object (e.g., jewelry) that cannot be removed and will directly contact the gel electrodes of the Empower Neuromodulation System at either treatment location
* Individual has an open incision, wound, scar, active infection or otherwise compromised skin at the treatment locations and will directly contact the gel electrodes of the Empower Neuromodulation System at either anatomic location
* Individual has a history of epilepsy or a seizure disorder
* Individual has been clinically diagnosed with peripheral nerve damage of the upper limbs or has numbness or tingling in an upper limb at least weekly
* Individual is female and currently pregnant or breastfeeding, has been pregnant within the past 6 months, intends to become pregnant during participation in the study, or is unwilling to practice birth control during participation in the study
* Individual will not, for the duration of participation in the study, have a living situation that provides regular access to an electrical outlet for charging the study device and smartphone
* Individual has used an investigational drug, biologic, or medical device in the past 4 weeks
* Individual is deemed unsuitable for enrollment in the study by the investigator based on the subject's history or physical examination
21 Years
ALL
No
Sponsors
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Theranova, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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KT Venkateswara-Rao, PhD
Role: PRINCIPAL_INVESTIGATOR
TheraNova, LLC
David Pennington, PhD
Role: PRINCIPAL_INVESTIGATOR
Northern California Institute of Research and Education
Locations
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University of California, San Francisco
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Countries
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Other Identifiers
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CRD-12-1477-01
Identifier Type: -
Identifier Source: org_study_id
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