AUD1: Treatment Parameters for the Empower Neuromodulation System (ENS)

• Sponsor: Theranova, L.L.C. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03807544
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 9.1

Study Details

Study Description

Brief Summary

The subject will be administered a treatment at a treatment location and then be asked if he/she believes it is the active treatment, sham treatment, or does not know. A clinical-grade nerve conduction assessment system will be used both to provide electrical stimulation at four locations to record peripheral responses. The subject will self-administer two treatment sessions at two active treatment sites.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Device: TENS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study to Optimize and Validate the Treatment Parameters for the Empower Neuromodulation System
• Actual Study Start Date: Jan 15, 2019
• Actual Primary Completion Date: Mar 13, 2019
• Actual Study Completion Date: Mar 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TENS treatment arm This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.	Device: TENS; Transcutaneous electrical nerve stimulation

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experienced Effective Electrode Placement [2 hours, length of study visit]

   Compare two active treatment electrode locations to evaluate the effect of electrode placement on the appearance of sensory nerve action potentials, including tingling sensation, along the stimulated nerve using electromyography (EMG).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Is 21-75 years old

2. Can provide informed consent

3. Currently has a stable living situation

4. Had one heavy drinking week (>7 drinks/week for women; >14 drinks/week for men) over the past 6 months

5. Has a breath alcohol concentration of 0.00% at enrollment

6. Is willing to follow all study procedures

Exclusion Criteria:

1. Has been diagnosed with schizophrenia, epilepsy, peripheral neuropathy, or nerve damage

2. 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)

3. Has a tattoo or conductive, ferromagnetic, or other magnetic-sensitive metals that cannot be removed from the hand, wrist, or biceps

4. Is currently pregnant or breastfeeding

5. Has a bleeding disorder, a history of deep vein thrombosis, or is on anticoagulation drugs

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

7. Is deemed unsuitable for enrollment in study by the PI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TheraNova	San Francisco	California	United States	94107

Sponsors and Collaborators

• Theranova, L.L.C.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 13, 2019

More Information

Publications

None provided.

• Responsible Party: Theranova, L.L.C.
• ClinicalTrials.gov Identifier: NCT03807544
• Other Study ID Numbers: CRD-12-1154
• First Posted: Jan 17, 2019
• Last Update Posted: Nov 17, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Theranova, L.L.C.: AUD; TENS
• Additional relevant MeSH terms: Alcoholism

Study Results

Participant Flow

Arm/Group Title	TENS Treatment Arm
Arm/Group Description	This study is a usability study, where all subjects will receive the same experimental treatment (both palms and wrists) for their single visit. TENS: Transcutaneous electrical nerve stimulation
Period Title: Overall Study
STARTED	17
COMPLETED	17
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	TENS Treatment Arm
Arm/Group Description	This study is a usability study, where all subjects will receive the same experimental treatment for their single visit. TENS: Transcutaneous electrical nerve stimulation
Overall Participants	17
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	46.82
Sex: Female, Male (Count of Participants)
Female	9 52.9%
Male	8 47.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 11.8%
Not Hispanic or Latino	15 88.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 17.6%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 29.4%
White	9 52.9%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	17 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experienced Effective Electrode Placement
Description	Compare two active treatment electrode locations to evaluate the effect of electrode placement on the appearance of sensory nerve action potentials, including tingling sensation, along the stimulated nerve using electromyography (EMG).
Time Frame	2 hours, length of study visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TENS Location - Palm	TENS Location - Wrist
Arm/Group Description	Measuring SNAP/Tingling off of the Palm location (active treatment site)	Measuring SNAP/Tingling off of the Wrist location (active treatment site)
Measure Participants	17	17
Count of Participants [Participants]	17 100%	17 NaN

Adverse Events

Time Frame	One 2-hour visit
Arm/Group Title	TENS Treatment Arm
Arm/Group Description	This study is a usability study, where all subjects will receive the same experimental treatment for their single visit. TENS: Transcutaneous electrical nerve stimulation
All Cause Mortality
	TENS Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Serious Adverse Events
	TENS Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Other (Not Including Serious) Adverse Events
	TENS Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.