Alcohol Use Disorder
Conditions
Keywords
AUD, TENS
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.
Interventions
DEVICETENS
Transcutaneous electrical nerve stimulation
Sponsors
Theranova, L.L.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TENS Treatment Arm This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.
TENS: Transcutaneous electrical nerve stimulation | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | TENS Treatment Arm |
|---|---|
| Age, Continuous | 46.82 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
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).
Time frame: 2 hours, length of study visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TENS Location - Palm | Number of Participants Who Experienced Effective Electrode Placement | 17 Participants |
| TENS Location - Wrist | Number of Participants Who Experienced Effective Electrode Placement | 17 Participants |