Trial Outcomes & Findings for Pilot Evaluation of the Empower Neuromodulation System in AUD Patients (NCT NCT03983317)

Last Updated: 2020-11-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Baseline week and Week 2 of the treatment phase

Results posted on

2020-11-18

Participant Flow

Participants completed the Baseline Phase first, so participants who did not complete the Baseline Phase did not start the Treatment Phase.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	25
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Physician Decision	5

Baseline Characteristics

Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment n=25 Participants 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
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline week and Week 2 of the treatment phase

Population: Participants who completed the study

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.

Outcome measures

Outcome measures
Measure	Active Treatment n=20 Participants 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
Change in Mean Number of Alcoholic Drinks Consumed Per Day	-1.1 Change in alcoholic drinks per day Standard Deviation 1.7

PRIMARY outcome

Timeframe: Through study completion, an average of 3 weeks

Population: All participants

Safety assessment via device-related adverse events

Outcome measures

Outcome measures
Measure	Active Treatment n=20 Participants 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
Number of Participants With Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Baseline week and Week 2 of the treatment phase

Population: Participants who completed the study

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.

Outcome measures

Outcome measures
Measure	Active Treatment n=20 Participants 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
Decrease in Mean Alcohol Craving Intensity	-13 Change in units on 100-mm VAS scale Standard Deviation 17

SECONDARY outcome

Timeframe: Study completion, at approximately 3 weeks

Population: Participants who completed the study.

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").

Outcome measures

Outcome measures
Measure	Active Treatment n=20 Participants 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
Usability	76 Score on the SUS survey scale Standard Deviation 15

Adverse Events

Active Treatment (AEs Occurred During the Two-week Treatment Phase)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Treatment (AEs Occurred During the Two-week Treatment Phase) n=25 participants at risk 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
Vascular disorders Deep vein thrombosis	4.0% 1/25 • Number of events 1 • 3 weeks
General disorders Head injury	4.0% 1/25 • Number of events 1 • 3 weeks

Other adverse events

Adverse event data not reported

Additional Information

Vice President of Research and Development

TheraNova, LLC

Phone: 415-926-8616

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place