Study to Optimize and Validate the Treatment Parameters for the Empower Neuromodulation System
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: Theranova, L.L.C.

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TheraNova, LLC 
 
March 13, 2019 
 
Study Title 
Study to optimize and validate the treatment parameters for the 
Empower Neuromodulation System 
Study & Revision Number 
CRD-12-1154 Rev 1 
Device 
Empower Neuromodulation System 
Objectives 
1. Compare two active treatment electrode locations to 
evaluate the effect of electrode placement on the 
appearance of sensory nerve action potentials (SNAPs). The 
appearance of SNAPs indicates effective sensory nerve 
stimulation. 
2. Evaluate the usability of each of the two active treatment 
electrode locations (via the System Usability Survey (SUS)). 
3. For one sham treatment electrode location (i.e. Sham #1), 
evaluate subject blinding, i.e. does the subject believe it is 
the active or sham treatment. 
4. Compare two sham treatment electrode locations to confirm 
that the sham locations do not induce SNAPs. 
Indications for 
Use/Subject Population 
After initial development, we will propose that the Empower 
Neuromodulation System is indicated for the treatment of 
alcohol use disorder (AUD). Per the inclusion criteria of this pilot 
study, enrollment in this study is not restricted to only subjects 
with AUD. 
 
The subject population is adult males or females age 21-75 
years old. 
Study Design 
Pilot feasibility study to optimize and validate treatment 
parameters. 
Number of Subjects 
Up to 40 
Number of Sites 
One (1) 
Study Procedures Outline 
1. Screening and ICF 
2. Breath alcohol test 
3. Eligibility review 
4. The subject will be administered a 5-minute treatment at a 
sham treatment location and then be asked if he/she 
believes it is the active treatment, sham treatment, or does 
not know. 
5. Sensory nerve action potential (SNAP) assessment. A 
clinical-grade 
nerve 
conduction 
assessment 
system 
(UltraPro 1000, Natus, Inc.) will be used both to provide 
electrical stimulation at each of four locations (two potential 
active treatment sites and two potential sham treatment sites 
and to record SNAPs during stimulation. The appearance of 
SNAPs are an indication of sensory nerve stimulation. 
6. The subject will self-administer a 10-minute treatment 
session at one active treatment site. After a 5-minute break, 
the subject will self-administer a 10-minute treatment 
session at the other active treatment site. After each 

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treatment session, the subject will complete two usability 
surveys about the treatment. 
7. Subject compensation 
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 skin at the 
electrode sites 
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 
Safety 
Adverse Events will be recorded and reported appropriately 
throughout the study. 
Sample Size Calculations 
For the two active treatment sites, the percent of subjects who 
experience effective stimulation of the nerve via SNAP 
assessment will be compared via a two-proportion z-test (p≤0.05 
for statistical significance).