Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

Alcohol Use Disorder Clinical Trial

Official title:

Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03983317
• Other study ID #: CRD-12-1176-01
• Secondary ID: R43AA027188-01
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: March 26, 2020

Study information

• Verified date: November 2020
• Source: Theranova, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 26, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Is male or female = 21 year of age at Visit 1

• Has a current diagnosis of alcohol use disorder per DSM-5 by clinician assessment

• Endorses Criterion 4 in DSM-5

• Has a desire to maintain abstinence or, if not abstinent, a desire to reduce or quit alcohol use

• Has a breath alcohol concentration of 0.00% at enrollment

• Is able to provide informed consent

• Is able to understand spoken and written English

• Is capable and willing to follow all study-related procedures

Exclusion Criteria:

• Has been diagnosed with unstable psychosis, epilepsy, peripheral neuropathy, or nerve damage

• Requires acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD)

• Has implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)

• Has an electrically conductive metal object (e.g. jewelry) that cannot be removed from the palm and will directly contact the gel electrodes of the Empower Neuromodulation System

• Will not, for the duration of the participation in the study, have a living situation that provides regular access to an electrical outlet.

• Is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study

• Has used an investigational drug/device therapy within the past 4 weeks

• Is deemed unsuitable for enrollment in the study by the PI

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Device:
• Empower Neuromodulation System
Transcutaneous electrical nerve stimulation

Locations

Country	Name	City	State
United States	NCIRE	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Theranova, L.L.C.	National Institute on Alcohol Abuse and Alcoholism (NIAAA), Northern California Institute of Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline week and Week 2 of the treatment phase
Primary	Number of Participants With Adverse Events	Safety assessment via device-related adverse events	Through study completion, an average of 3 weeks
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.	Baseline week and Week 2 of the treatment phase
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").	Study completion, at approximately 3 weeks