Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: Theranova, L.L.C.

Protocol CRD-12-1176-01, PI: Steven Batki, MD 
 
 
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Protocol Template © CFFT TDN   Effective: 12 SEP 2007 
 
THERANOVA, LLC 
Clinical Research Protocol 
PILOT EVALUATION OF THE EMPOWER NEUROMODULATION SYSTEM IN 
AUD PATIENTS 
NCT03983317  
Protocol Number: 
CRD-12-1176-01 
Version Date: 
December 18, 2018 
Investigational Product: 
Empower Neuromodulation System 
IND/IDE Number: 
N/A, non-significant risk study 
Development Phase: 
Feasibility 
Sponsor: 
TheraNova, LLC 
101 Mississippi St. 
San Francisco, CA 94107 
Funding Organization: 
NIH-NIAAA 
Principal Investigator: 
Name:             Steven Batki, MD 
 
Telephone: 
415-221-4810 ext. 23671 
Fax: 
 
415-750-2187 
E-mail: 
Steven.Batki@ucsf.edu 
Coordinating Center: 
Not applicable 

Protocol CRD-12-1176-01, PI: Steven Batki, MD 
 
 
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PROTOCOL SYNOPSIS 
TITLE 
Pilot evaluation of the Empower Neuromodulation System in AUD 
Patients 
SPONSOR 
TheraNova, LLC 
FUNDING 
ORGANIZATION 
NIH-NIAAA 
NUMBER OF SITES 
One (1) 
RATIONALE 
Alcohol use disorder (AUD) is a major public health concern, 
affecting over 16 million Americans. AUD is a highly disabling 
disease associated with many physical and psychiatric co-morbidities. 
Current AUD interventions include pharmacologic treatment and 
behavioral therapies; however, these are not very effective, having 
high rates of relapse soon after initial successful treatment. Therefore, 
new, more effective therapies are needed. 
Preclinical and clinical research has shown that stimulation of the 
ulnar sensory nerve via acupuncture can inhibit dopamine signaling in 
the brain’s mesolimbic circuit that is responsible for drug craving and 
reward. While acupuncture is an excellent adjunct procedure in 
treatment centers, it also has limited patient acceptability as it requires 
patients to seek treatment in clinic. Therefore, TheraNova has 
developed the Empower Neuromodulation System, a portable, safe, 
easy-to-use neuromodulation device that stimulates the ulnar sensory 
nerve to enable a convenient and acceptable therapy to treat AUD. 
The overall goal of this study is to conduct a 3-week pilot 
investigation into the safety, effectiveness, and usability of the 
Empower Neuromodulation System in AUD patients. 
STUDY DESIGN 
This is an open-label, pilot study. 
PRIMARY 
OBJECTIVE 
 Safety: Evaluate safety of the Empower Neuromodulation 
System treatment via device-related adverse events and 
participant-reported side effects.  
 Effectiveness:  Evaluate the effectiveness of Empower 
Neuromodulation System treatment for reducing alcohol 
consumption (via self-reported daily consumption) over a 2-
week treatment phase and compared to a pre-treatment baseline 
phase. 
 

Protocol CRD-12-1176-01, PI: Steven Batki, MD 
 
 
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SECONDARY 
OBJECTIVES 
The secondary study objectives are the following: 
 Effectiveness: Evaluate the effectiveness of the Empower 
Neuromodulation System treatment for reducing alcohol 
craving (via self-reported craving intensity (VAS responses)) 
over a 2-week treatment phase and compared to a pre-treatment 
baseline phase.  
 Usability: Evaluate the usability of the Empower 
Neuromodulation System via the System Usability Survey 
(SUS). 
NUMBER OF 
PARTICIPANTS 
25 
PARTICIPANT 
SELECTION 
CRITERIA 
Inclusion Criteria: 
1. Is male or female ≥ 21 year of age at Visit 1 
2. Has a current diagnosis of alcohol use disorder per DSM-5 by 
clinician assessment  
3. Endorses Criterion 4 in DSM-5 
4. Has a desire to maintain abstinence or, if not abstinent, a desire to 
reduce or quit alcohol use  
5. Has a breath alcohol concentration of 0.00% at enrollment 
6. Is able to provide informed consent  
7. Is able to understand spoken and written English 
8. Is capable and willing to follow all study-related procedures 
Exclusion Criteria: 
1. Has been diagnosed with unstable psychosis, epilepsy, peripheral 
neuropathy, or nerve damage 
2. Requires acute medical detoxification from alcohol based on a score 
of 12 or more on the Clinical Institute Withdrawal Assessment of 
Alcohol Scale (CIWA-AD)   
3. 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) 
4. Has an electrically conductive metal object (e.g. jewelry) that 
cannot be removed from the palm and will directly contact the gel 
electrodes of the Empower Neuromodulation System 
5. Will not, for the duration of the participation in the study, have a 
living situation that provides regular access to an electrical outlet. 
6. Is pregnant, breastfeeding, or unwilling to practice birth control 
during participation in the study 
7. Has used an investigational drug/device therapy within the past 4 
weeks 
8. Is deemed unsuitable for enrollment in the study by the PI 

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TEST PRODUCT, 
DOSE, AND ROUTE 
OF 
ADMINISTRATION 
Transcutaneous electrical nerve stimulation of the ulnar nerve at the 
palm with the Empower Neuromodulation System 
During the Treatment Phase (Weeks 2-3 of the study), the participant 
will self-administer a treatment session twice per day. Each treatment 
session consists of a total of 30 minutes of treatment, with 15 minutes 
of treatment on one hand followed by 15 minutes on the other hand.  
CONTROL 
PRODUCT, DOSE 
AND ROUTE OF 
ADMINISTRATION 
No control treatment will be used in this study. However, each 
participant will serve as his/her own control via data collection during 
the Baseline Phase (Week 1 of the study). For each participant, 
treatment effects during the Treatment Phase (Weeks 2 and 3) will be 
compared with the Baseline Phase. 
DURATION OF 
PARTICIPANT 
PARTICIPATION 
AND DURATION OF 
STUDY 
Participants will be on study for up to 35 days 
Screening:  up to 7 days 
Baseline Phase:  5-11 days 
Treatment Phase:  11-17 days 
The total duration of the study is expected to be 9 months. Eight 
months for participant recruitment and 1 month for final participant 
follow-up. 
STATISTICS 
Primary Analysis Plan 
The primary effectiveness endpoint will be change in alcohol 
consumption as a result of treatment. We will compare averages of 
daily drinking for the final week of the Treatment Phase (Week 2) vs. 
the week of the Baseline Phase via a paired t-test. 
Rationale for Number 
of Participants 
As a pilot study, the sample size is not based on a formal power 
calculation. Based on sample sizes for previous pilot studies for 
neuromodulation studies in addiction and mental health treatment, we 
aim to recruit 25 participants to obtain a meaningful cohort for a pilot 
evaluation of the Empower Neuromodulation System.