Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
Phase: NA
Conditions: Neuropathic Pain
Sponsor: University of Miami

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TITLE PAGE 
Full protocol title: Addressing Disparities in Neuromodulation for 
Rehabilitation: A Mixed Methods Approach to Optimize Access for 
Underrepresented Racial Minorities 
Protocol Version Date: 12/16/2023 
PI Name: Marlon Wong 
NCT Number: NCT05896202

 
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1) 
Protocol Title 
Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods 
Approach to Optimize Access for Underrepresented Racial Minorities 
 
2) 
IRB Review History* 
Approved (ID 20230154) 
3) 
Objectives* 
We will develop culturally sensitive videos for video-enhanced informed consent 
(VE-IC) with neuromodulation techniques (i.e., vagus nerve [taVNS] and 
transcranial magnetic [rTMS] stimulation techniques).  We will use these videos in 
a mixed method study design to examine factors that influence the interest or 
aversion to participate in neurostimulation research in URM with persistent pain.  
Findings will provide insight on modifiable factors and recruitment/retention 
strategies to optimize racial minority representation in neurostimulation research. 
The videos and data from this project will be used in our future research on 
neurostimulation, and they will be made available for use by others.  This study is 
part of a larger research agenda designed to inform the development of personalized 
pain relief programs based on using patient preferences and a mechanistic 
understanding of the interventions to integrate neurostimulation interventions into 
multimodal care for persistent pain.   
Aim 1: Development of culturally sensitive videos for enhance informed 
consent with neurostimulation and determination of factors that influence 
minority interest in participating in neurostimulation research. We hypothesize 
that participants will have greater interest in participation and expectations for 
pain relief with the modality for which they received VE-IC in comparison to 
modalities without VE-IC. 
Aim 2: Examination of the influence that video enhanced informed consent has 
on expectations with taVNS and on treatment intended effects.  We hypothesize 
that individuals who had VE-IC for taVNS will demonstrate greater expectations for 
pain relief and greater changes in heart rate variability (HRV). 
Aim 3: Explore the intended effects of taVNS in people with neuropathic pain.  
The sample consent form and brochure for taVNS will not specify the exact 
location on the ear for active taVNS.  Thus, participants in the TMS video only 
group will be sufficiently naïve for participation in a single blinded crossover 
design.  Half of the TMS-only group will receive active taVNS in visit 2, the other 
half will receive sham taVNS in visit 2, and they will crossover for visit 3 (table 1).  
We hypothesize that there will be a greater increase in HRV and SICI with active 
taVNS than with sham taVNS. 
 
4) 
Background* 
Noninvasive neurostimulation techniques show promise for improving chronic pain 
management.1-3  Underrepresented racial minorities (URM) are at greater risk than 
non-minority individuals for persistent pain conditions4-6; however, recruiting URM 
for adequate representation in neurostimulation research remains an unmet 
challenge. Improving recruitment of URM participants in neurostimulation research 

 
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is critical to enhancing our understanding of factors that influence outcomes with 
these modalities and to maximize the generalizability of research findings to a 
diverse population. 
Traditional consent forms have been criticized for being too long and difficult to 
understand, and these consent forms may be a barrier to URM participation in 
research, as limited literacy disproportionately affects URM and the text heavy 
format may foster distrust.  Video-enhanced informed consent (VE-IC) has been 
recommended to improve recruitment of URM in cancer and cardiovascular trials; 
however, VE-IC has not been studied in neuromodulation research. 
 
5) 
Inclusion and Exclusion Criteria* 
We anticipate that most participants in this study will have chronic pain associated 
with chemotherapy induced peripheral neuropathy (CIPN); however, we will recruit 
Black and Hispanic people with chronic neuropathic pain of any etiology (e.g., 
diabetic neuropathy and radiculopathy) to optimize the rapid recruitment of these 
URM.  
Inclusion Criteria: 1) between the ages of 18-80 years; 2) neuropathic pain lasting 
longer than 3 months (i.e., complaint of sensation of burning, stabbing or pressing 
pain, shooting or shock like pain, or paresthesias); 3) Neuropathic Pain Symptom 
Inventory score ≥10. 4) self identifies as Black or Hispanic 
Exclusion Criteria: 1) any unstable medical condition or medical contraindication to 
moderate physical exertion (e.g., unstable angina or cardiac arrythmia), 2) 
pregnancy, 3) currently taking Buprenorphine or recently stopped taking (within 1 
month), 4) presence of cognitive impairment or language barrier that impairs full 
autonomy in the consent process or in the ability to participate in detailed 
interviews, 5) implants in the head or neck, cochlear implants, or pacemaker, 6) 
head or neck metastasis or recent ear trauma, 7) history of seizures. 
 
6) 
Study-Wide Recruitment Methods* 
All recruitment will be in accordance with the Health Insurance Portability 
and Accountability Act (HIPAA), by the SCCC Protocol Review and 
Monitoring Committee and by the UM Department of Physical Therapy 
Research Leadership Team.  
Black and Hispanic patients with persistent pain will be recruited for a 2-
phased mixed methods study. Flyers will be placed in Uhealth clinics 
(Uhealth Physical Therapy, Uhealth Advanced Pain Management Center, 
and Sylvester Comprehensive Cancer Center) to recruit patients with 
neuropathic pain.  In addition, the patient census of specific UHealth clinics 
(i.e., Dr. Peter Hosein’s medical oncology clinic, the Sylvester Posner 
Lymphema Clinic, and the Uhealth Pain Physical Therapy Clinic) will be 
used for recruitment. Physicians will be informing participants first about 
the study before a member of the study team will be contacting patients. 
Telephone numbers and/or emails of potential participants and they will be 
called to screen for inclusion.  Patients who provide verbal consent to be 

 
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contacted for research purposes will be called by one of the research 
assistants. 
The Sylvester Behavioral and Community-Based Research (BCSR) 
Shared Resource will be used to assist with recruitment of patients with 
chemotherapy induced peripheral neuropathy (CIPN).   
 
7) 
Study Design  
 
Primary Purpose: Other.  This study will utilize principles of community-based 
participatory research to develop and test educational materials for consenting people 
to neurostimulation research. 
Study Phase: N/A 
Interventional Study Model: Parallel  
Number of Arms: 2 
Masking: Subject only 
Allocation: Randomized 
Enrollment: 28 
 
8) 
Study Timelines* 
Each participant will complete 3 visits for a total of ~10 hours, and it is expected 
that the visits are completed within 1-2 weeks of each other.  Thus, participants will 
be enrolled for less than 3 weeks on average.   
 
9) 
Study Endpoints* 
Primary Outcome Measure Title: Change in Heart Rate Variability 
(HRV) 
Primary Outcome Measure Description: HRV will be measured with an 
H10 chest strap device (Polar, Finland) 
Primary Outcome Measure Timeframe: at visits 2 and 3, Baseline (15 
minutes pre taVNS application) to 15 minutes post 1 hour application of 
taVNS  
Secondary Outcome Measure Title: Change in EXPECT questionnaire 
scores 
Secondary Outcome Measure Description: scores ranging from 0-40 
with higher scores representing greater expectations for pain relief 
Secondary Outcome Measure Timeframe: at visits 2 and 3, Baseline 
(pre taVNS application) and repeated post 1 hour application of taVNS 
10) Arms and Interventions 
All participants will be educated on both neurostimulation modalities (taVNS and 
TMS).  This study will include 2 arms.  Group 1 will receive a supplemental video 
on taVNS, in addition to consent forms and brochures describing both modalities.  

 
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Group 2 will only receive the consent forms and brochures describing both 
modalities.  While all participants will provide important feedback on consent 
forms and brochures for both modalities, Group 1 will provide additional feedback 
specific to the taVNS video they watched.  
 
We will assess the impact of the taVNS video (by comparing Group 1 to Group 2) 
on participant expectations and intended effects with a single 60-minute bout of 
taVNS. 
 
11) Procedures Involved* 
Black and Hispanic patients with persistent pain will be recruited for a 2-
phased mixed methods study. All data collection will take place at the 
Lynn Rehabilitation Center.  In the first phase, participants will be 
educated on two neurostimulation modalities (taVNS and TMS).  
Educational materials will include 1:1 discussion of a typical consent form 
for each modality, a brief (2 page) description with pictures for each 
modality, and the brief video for taVNS for those randomly allocated to 
Group 1.  The development of these educational resources is a primary 
objective of this project, and the first few months will be spent consulting 
with experts to develop these educational resources and to produce the 
videos.   
Structured interviews and questionnaires will be used to examine 
participants interest in participating in research for each of the modalities, 
gather their feedback on each educational tool, and to determine factors 
that influence their interest. This first phase will take place in a single 
session, and the session is anticipated to take ~2 hours to complete.  
Participants will be given the choice to complete this first visit in person 
or via Zoom in order to decrease participation burden.  For the second 
phase, all participants will receive active taVNS, but only Group 2 will 
receive both active and sham taVNS in a randomized crossover design.  
All participants will first complete a pretrial assessment battery, followed 
by a 60-minute trial of taVNS applied with continuous monitoring of HRV 
during quiet sitting, and then concluded with a posttrial assessment.  The 
second phase will be completed in two sessions that are anticipated to last 
~4 hours each.  In summary, participants will complete 3 visits for a total 
of ~10 hours to complete the study.  
 
Visit 1 
Visit 2 
Visit 3 
taVNS video (n=12) 
Education and 
baseline 
Active taVNS 
1-wk follow up 
Brochures only 
(n=12)         
      6 participants 
 
Education and 
baseline 
 
Active taVNS 
 
Sham taVNS 
      6 participants 
Education and 
baseline 
Sham taVNS 
Active taVNS 

 
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A detailed description of each procedure is provided below: 
 
EXPECT questionnaire7: The EXPECT is a 4-item questionnaire that assesses 
expectations for pain improvement.  Each of the 4 items is scored on an 11-point 
scale, with 0 being no change and 10 representing complete relief.  It is 
anticipated that this questionnaire will take less than 5 minutes to complete. 
 
Heart rate variability (HRV): HRV will be measured with an H10 chest 
strap device (Polar, Finland) and will serve as the primary endpoint for 
response to taVNS in Aim 2.  Participants will wear the chest strap 
continuously throughout the application of taVNS. 
 
taVNS: A portable taVNS Stimulator (Soterix Medical, 
Woodbridge, NJ) will be used with flexible hydrogel electrodes 
to administer taVNS at the cymba concha (Figure 2), using 
monophasic pulses (pulse width:500 µs; frequency 10 Hz), and 
delivered up to 200% of the perception threshold, but kept 
below the pain threshold, for 60 minutes.  This device is 
approved for research purposes, and these parameters have 
been shown to maximize cardiovagal response with taVNS.8  Participants will be 
quiet sitting in a comfortable chair during the application of taVNS. 
Please see the Risks to Subjects section for procedures performed to 
lessen the probability or magnitude of risks. 
 
12) Data Management* 
The principal investigator will be responsible for all data management and 
analyses.  A research assistant will assist with data entry and qualitative data 
coding. All quantitative data will be entered and stored in the University of 
Miami REDCap system.  NVivo 12 software (QSR International, United 
States) will be used for qualitative data management and analyses, and 
SPSS version 28 (IBM, United States) will be used for quantitative analyses 
(i.e., descriptive statistics).   
 
13) Provisions to Monitor the Data to Ensure the Safety of Subjects* 
Safety information will be collected during the taVNS trial study visit for 
this research and entered into Velos for tracking.   All adverse effects will 
be reported to the study team, the IRB, and to the SCCC Data & Safety 
Monitoring Committee.  All research activities will be stopped in the case 
Figure 2. taVNS 
electrode application 

 
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of a single serious adverse reaction (i.e., seizure) or if 3 or more minor 
adverse reactions (e.g., skin irritation from electrodes) are observed.  A 
corrective plan (e.g. change in TMS or taVNS protocol) must be approved 
by the study team, IRB, and SCCC Data & Safety Monitoring Committee 
before research activities can be resumed. 
The plan might include establishing a data monitoring committee and a 
plan for reporting data monitoring committee findings to the IRB and the 
sponsor. 
14) Community-Based Participatory Research* 
Prior to initiating research activities, a 4-member community advisory 
board (CAB) will be assembled, consisting of 2 people from each ethnicity 
(non-Hispanic African American and Hispanic), and the CAB will meet 4 
times over the course of the year to provide general feedback on the 
project design, plan, and progress, including feedback on video scripts, 
final video products, and video dissemination plan.  At least 1 person from 
each ethnic group on the CAB must have chronic pain (n≥2).   
15) Sharing of Results with Subjects* 
NA 
16) Setting 
Participants will be recruited from Sylvester Comprehensive Cancer 
Center, UHealth Physical Therapy, and from the UHealth Advanced Pain 
Management Clinic.   
The research procedures will be conducted at the Lynn Rehabilitation 
Center for The Miami Project to Cure Paralysis at UHealth/Jackson 
Memorial. The Christine E. Lynn Rehabilitation Center for The Miami 
Project to Cure Paralysis at UHealth/Jackson Memorial was designed from 
scratch to be one of the country’s elite facilities for patients recovering 
from traumatic brain injury, spinal cord injury, cancer treatment, and other 
complex conditions. The stunning 250,000-square-foot, nine-story 
structure opened in 2020, and it houses 80 inpatient beds and features 
world-class amenities and next-generation rehabilitative technology.  
Every aspect of the facility underscores a focus on comprehensive care. 
The building’s layout ensures that clinical care and research share space, 
so that patients and families see the scientists who are developing 
treatments, and researchers interact with real people who need the results 
of their work—a constant reminder of the way Lynn Rehabilitation Center 
integrates academic study with the day-to-day treatment of patients. 
Dr. Wong’s Clinical Pain Research Lab is located in the Lynn 
Rehabilitation Center.  His dedicated lab space is equipped with a PC, 
laptop, secured internet access, filing cabinets, office and medical 
supplies, and research equipment and supplies. 

 
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A community advisory board will be formed to provide feedback and 
guidance on the videos produced as part of this research.  Please see 
details in the Community-Based Participatory Research* section. 
17) Resources Available 
 
Research Team: 
 
Marlon Wong, DPT, PhD 
Principal Investigator 
Dr. Marlon Wong is an Associate Professor of Clinical at the University of Miami Miller School 
of Medicine within the Department of Physical Therapy. Dr. Wong has extensive research and 
clinical experience in the assessment and management of neuropathic pain in a variety of patient 
populations.  As the PI, he will provide expertise and oversee the execution of the aims outlined in 
this research project. He will develop and conduct the methodology, data collection, data analysis, 
and manuscript preparation. Dr. Wong has over 20 years of clinical experience using electrical 
stimulation for pain management.  In addition, he attended a weeklong intensive training on 
advanced noninvasive neurostimulation techniques (i.e., taVNS and TMS) through the National 
Center of Neuromodulation for Rehabilitation. Dr. Wong will dedicate .2 FTE to this project (8 hrs 
per week), in order to complete the work in the described timeline. 
 
Lisa McTeague, PhD 
Mentor/Collaborator 
Dr. McTeague is a clinical psychologist and an Associate Professor in the Brain Stimulation 
Laboratory of the Department of Psychiatry and Behavioral Sciences at the Medical University of 
South Carolina.  Dr. McTeague is an expert in neurostimulation techniques, specifically in taVNS 
and TMS, and she serves as faculty in the National Center of Neuromodulation for Rehabilitation 
at the Medical University of South Carolina (MUSC).   She has over ten years of experience 
working with these modalities to develop innovative assessment and treatment methods to 
renormalize neural networks and restore behavior related to anxiety and mood disorders and 
trauma exposure. Her current work is purposefully transdiagnostic and significantly applicable to 
pain research.  She will provide expertise and mentorship on neurostimulation research and heart 
rate variability.  Dr. Wong will spend a week at Dr. McTeague’s lab in MUSC to complete 
intensive training in paired-pulse TMS procedures prior to initiating research activities. Dr. 
McTeague will only have access to de-identified information. 
 
 
Eva Widerstrom-Noga, PhD, DDS 
Mentor/Collaborator 
 Dr. Widerstrom-Noga is a Professor of Neurological Surgery and Rehabilitation Medicine at 
UM, and she is the Principal Investigator of the Clinical Pain Research Laboratory of The Miami 
Project to Cure Paralysis. She is an expert in pain assessment and pain classification, and cross-
disciplinary clinical pain research (pain physiology and pain psychology), with three decades of 
experience in the field.  Her research involves both qualitative and quantitative pain 
methodologies in persons with chronic pain after neurotrauma. She will provide expertise and 
mentorship on pain and mixed methods research.  
 
Frank Penedo, PhD  
Mentor/Collaborator 

 
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Dr. Penedo is a Professor of Psychology and Medicine and Center Associate Director for Cancer 
Survivorship and Translational Behavioral Sciences at the UM SCCC.  He has over 20 years’ 
experience as a clinical health psychologist with a focus on psycho-oncology, and he is an expert 
in evaluating the impact of sociocultural, biobehavioral, psychosocial determinants of health 
outcomes in cancer survivors.  Dr. Penedo’s work also involves translational research evaluating 
the impact of symptom and toxicities monitoring and management in ambulatory oncology, the 
patient reported outcomes (PROs) in survivorship care, precision oncology, and phase-1 trials, as 
well as the implementation of culturally adapted treatments delivered within health systems.  He 
will provide mentorship on cancer trials and patient centered research in cancer populations.   
 
Melissa Tovin, PhD, PT 
Mentor/Collaborator 
Dr. Tovin is a Professor of Physical Therapy at Nova Southeastern University.  She is an expert 
in both qualitative and mixed methods research with over 20 years’ experience.  Dr. Tovin will 
provide expertise and mentorship in the application of qualitative and mixed methods research 
methodology. Dr. Tovin will only have access to de-identified information. 
 
 
Peter Hosein, MD 
Collaborator 
Dr. Hosein is an Associate Professor of Medicine and the Co-leader of the Gastrointestinal 
Cancers SDG at the UM SCCC.  Dr. Hosein has over 12 years’ experience as a medical 
oncologist, and he is an expert on gastrointestinal cancers having participated in numerous phase 
I, II, and III trials. Dr. Hosein will recruit patients with CIPN for this study and will monitor the 
data to ensure the safety of participants.   
18) Prior Approvals 
Approval will be obtained from the National Center of Neuromodulation 
for Rehabilitation (subcontract funding agency) and from NIH (parent 
funding agency) prior to commencing the research.  
19) Confidentiality 
 
Confidentiality will be maintained by assigning participant identification numbers 
at the beginning of the study. All data will be identified using these ID numbers. 
The personal information included as data will consist of the gender, age, race, 
ethnicity, and cancer type and treatment. This information will be kept in a locked 
file cabinet and stored in a password-protected digital file on the encrypted 
database at the University of Miami Physical Therapy Department located at 5915 
Ponce De Leon Blvd, Plumer Building 1st Floor, Miami, FL 33146. Signed 
consent forms will be kept in a master file in a locked file cabinet. Only the 
principal investigator and research assistant will have access to participant’s 
personal information and data.  
 
20) Provisions to Protect the Privacy Interests of Subjects 
Participants will only interact directly with their respective Uhealth providers for 
recruitment (i.e., a Uhealth provider who already has access to the patient census 
would contact the patient for study recruitment, and the data collection will be 

 
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performed by investigators who are members of the Uhealth clinical team).  
Thus, the intrusiveness of participation is minimized.   
Only IRB approved research team members will have access to study records. 
Overall study results will not be shared with study participants, individually. 
Confidentiality will be maintained by assigning subject identification numbers at 
the beginning of the study. All data will be identified using these ID numbers. 
This information will be kept in a locked file cabinet and stored in a password-
protected digital file on the encrypted database in the office of the PI in the 
University of Miami Department of Physical Therapy located at 5915 Ponce de 
Leon Boulevard, 2nd Floor, Coral Gables, FL 33146. Signed consent forms will 
be kept in a master file in a locked file cabinet. Only the principal investigator 
and research assistant will have access to subject’s personal information and data.  
21) Compensation for Research-Related Injury 
Compensation will not be provided for research-related injury.  Funds to 
compensate participants for pain, expenses, lost wages, and other damages 
caused by injury are not available.  However, treatment will be available 
in most cases and their insurance may be billed or participants will have to 
pay. 
22) Economic Burden to Subjects 
There are no direct costs associated with participating in this study.  
However, transportation and parking may be an economic burden on some 
participants.  Participants will be paid $250 to compensate them for the 
economic and time burden ($50 upon completion of visit 1 and $200 for 
completion of visit 2). 
23) Consent Process 
We will follow SOP: Informed Consent Process for Research (HRP-090).  
The consent process will begin with the phone screening.  If they provide 
verbal consent to the phone screening and are deemed eligible for the 
study, then they will be invited to the Lynn Center.  At the Lynn Center, 
they will be educated on the study and provided with a written consent 
form to review and sign.   The consent form and all research documents 
will be available in English and Spanish.  Several of the research team 
members are bilingual and each participant will be consented in-person in 
the language which they are most comfortable.  Potential participants will 
have the opportunity to consult with family members or others and will 
have all questions addressed by the PI or other members of the study team. 
Potential participants will be briefed on their rights as a research subject, 
including their right to withdraw at any time with no negative 
consequences. 
 The study procedures will be reviewed with each participant at each phase 
of the study (i.e., taVNS and TMS procedures will be reviewed after 
completion of the mixed methods phase and prior to initiating the trial 
phase) and verbal consent will be re-obtained to ensure ongoing consent.  

 
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Each time that the verbal consent is obtained, it will be reiterated to the 
patient that they may choose to withdraw from the study at any time. 
Non-English-Speaking Subjects 
All study documents will be available in English and Spanish.  A 
bilingual study team member will be present at all times to answer any 
questions and to ensure that Spanish speaking participants fully 
understand.  As noted previously, each participant will be consented in-
person in the language which they are most comfortable. 
e-Consent 
Verbal consent for participation will first be obtained via a phone call or 
in-person.  During this phone call or in-person contact, eligibility will be 
determined by the research team at SCCC-Behavioral Community-Based 
Research Shared Resource department and documented in Ripple for 
recruitment tracking purposes only. Following verbal consent for 
participation, the participant will be scheduled for either a virtual or in-
person consent meeting, depending on their format preferences. The 
consent form and all research documents will be available in English, 
Spanish, and Haitian-Creole and the consent process will be conducted in 
their preferred language.  
Remote consent will also be used for participants who prefer to conduct all 
screening and interviews via Zoom.  Once a qualified person expresses 
their willingness to participate, the staff will contact the person via Zoom, 
to explain the research study to the participant and answer any questions 
that may arise, and to proceed to remotely Consent patient via RedCap.   
The  CTSI e-Consent Template will be used for both remote and in-person 
consent. We will send a copy of the consent document to the participant a 
few days before the discussion in order to allow them to read, develop a 
list of questions, and discuss the research with family or friends. A printed 
copy will be provided to in-person participants.  We will arrange a Zoom 
meeting that includes the person obtaining consent, the participant, and 
any additional people requested by the participant (e.g., relative, friend). 
During the meeting we will review and explain the information in the 
consent document, answer any questions the participant has about the 
study, ask the participant questions about the study to confirm their 
comprehension, and ask the participant if they consent to participate. If the 
participant agrees, then they will be asked to sign and date the consent 
document electronically.  Then we will explain to the participant that they 
will receive a copy of the signed documents via email. 
24) Process to Document Consent in Writing 
Consent will be documented in writing prior to initiating onsite data 
collection.  Please see the attached consent form. 

 
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25) Drugs or Devices 
The Soterix taVNS device is approved for research purposes, and it is 
being used in this study as intended.  The device will be stored and used in 
our lab at the Lynn Rehabilitation Center, and it will only be used on study 
participants and administered only by authorized investigators.  Our lab 
space is not a shared space and remains locked at all times when not in 
use.  No patient care takes place in the lab space.  
 
 
1. 
Ferreira NR, Junqueira YN, Correa NB, et al. The efficacy of transcranial direct 
current stimulation and transcranial magnetic stimulation for chronic orofacial pain: A 
systematic review. PLoS One. 2019;14(8):e0221110. doi:10.1371/journal.pone.0221110 
2. 
Stilling JM, Monchi O, Amoozegar F, Debert CT. Transcranial Magnetic and 
Direct Current Stimulation (TMS/tDCS) for the Treatment of Headache: A Systematic 
Review. Headache. Mar 2019;59(3):339-357. doi:10.1111/head.13479 
3. 
Farmer AD, Strzelczyk A, Finisguerra A, et al. International Consensus Based 
Review and Recommendations for Minimum Reporting Standards in Research on 
Transcutaneous Vagus Nerve Stimulation (Version 2020). Front Hum Neurosci. 
2020;14:568051. doi:10.3389/fnhum.2020.568051 
4. 
Knoebel RW, Starck JV, Miller P. Treatment Disparities Among the Black 
Population and Their Influence on the Equitable Management of Chronic Pain. Health 
Equity. 2021;5(1):596-605. doi:10.1089/heq.2020.0062 
5. 
Morales ME, Yong RJ. Racial and Ethnic Disparities in the Treatment of Chronic 
Pain. Pain Med. Feb 4 2021;22(1):75-90. doi:10.1093/pm/pnaa427 
6. 
Meints SM, Cortes A, Morais CA, Edwards RR. Racial and ethnic differences in 
the experience and treatment of noncancer pain. Pain Manag. May 2019;9(3):317-334. 
doi:10.2217/pmt-2018-0030 
7. 
Jones SM, Lange J, Turner J, et al. Development and Validation of the EXPECT 
Questionnaire: Assessing Patient Expectations of Outcomes of Complementary and 
Alternative Medicine Treatments for Chronic Pain. J Altern Complement Med. Nov 
2016;22(11):936-946. doi:10.1089/acm.2016.0242 
8. 
Badran BW, Mithoefer OJ, Summer CE, et al. Short trains of transcutaneous 
auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate. 
Brain Stimul. Jul - Aug 2018;11(4):699-708. doi:10.1016/j.brs.2018.04.004