Treatment Parameters for the Empower Neuromodulation System (ENS)

NCT03807544 | Completed Results FDA Device

• 1 other identifier: CRD-12-1154
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

AUD; TENS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

TENS treatment arm

EXPERIMENTAL

This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.

Device: TENS

Interventions

TENS DEVICE

Transcutaneous electrical nerve stimulation

TENS treatment arm

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is 21-75 years old
• Can provide informed consent
• Currently has a stable living situation
• Had one heavy drinking week (\>7 drinks/week for women; \>14 drinks/week for men) over the past 6 months
• Has a breath alcohol concentration of 0.00% at enrollment
• Is willing to follow all study procedures

You may not qualify if:

• Has been diagnosed with schizophrenia, epilepsy, peripheral neuropathy, or nerve damage
• 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 a tattoo or conductive, ferromagnetic, or other magnetic-sensitive metals that cannot be removed from the hand, wrist, or biceps
• Is currently pregnant or breastfeeding
• Has a bleeding disorder, a history of deep vein thrombosis, or is on anticoagulation drugs
• Has used an investigational drug/device therapy within the past 4 weeks
• Is deemed unsuitable for enrollment in study by the PI

Sponsors & Collaborators

• Theranova, L.L.C.: lead

Study Sites (1)

TheraNova

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Theranova

clindquist@theranova.com

14159268616

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 17, 2019
• Study Start: January 15, 2019
• Primary Completion: March 13, 2019
• Study Completion: March 13, 2019
• Last Updated: November 17, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-10

Locations

US (1)