Treatment Parameters for the Empower Neuromodulation System (ENS)

Alcohol Use Disorder Clinical Trial

— AUD1  

Official title:

Study to Optimize and Validate the Treatment Parameters for the Empower Neuromodulation System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807544
• Other study ID #: CRD-12-1154
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: March 13, 2019

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Device:
• TENS
Transcutaneous electrical nerve stimulation

Locations

Country	Name	City	State
United States	TheraNova	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Theranova, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced Effective Electrode Placement	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).	2 hours, length of study visit