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

T

TheraNova

Status

Completed

Conditions

Alcohol Use Disorder

Treatments

Device: TENS

Study type

Interventional

Funder types

Industry

Identifiers

NCT03807544
CRD-12-1154

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

17 participants in 1 patient group

TENS treatment arm
Experimental group
Description:
This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.
Treatment:
Device: TENS

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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