Combination Therapy of Home-based Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults With Knee Osteoarthritis
Phase: NA
Conditions: Osteo Arthritis Knee
Sponsor: University of Arizona

The University of Arizona  
 
 
Combination Therapy of Home-based 
Transcranial Direct Current Stimulation and 
Mindfulness-based Meditation for Self-
management of Clinical Pain and Symptoms in 
Older Adults with Knee Osteoarthritis 
 
 
 
 
 
 
 
NCT04375072 
July 24, 2024 

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Basic Information  
Title of Study: 
Combination Therapy of Home-based Transcranial Direct Current Stimulation 
and Mindfulness-based Meditation for Self-management of Clinical Pain and 
Symptoms in Older Adults with Knee Osteoarthritis 
Short Title: 
Home-based tDCS and Mindfulness-based Meditation for Self-management of 
Clinical Pain and Symptoms 
Principal Investigator 
Name: 
Hyochol Ahn 
Principal Investigator’s 
Department/Unit: 
College of Nursing 
 
1.0 
Background (Limit 1,000 words):  
Provide the scientific or scholarly background for the proposed Human Research. 
Discuss relevant prior experience or preliminary data (e.g., existing literature). 
Arthritis is one of the leading causes of pain, impairments of activities in daily life, and disability 
in people aged 45 and above. Of the 53 million adults diagnosed with arthritis, more than 22 
million (42%) reported trouble with their activities of daily living due to arthritis. Osteoarthritis 
(OA) is the most common of the arthritic conditions, with the knee being the most commonly 
affected joint. Patients with chronic pain, such as knee OA pain, do not have sufficient pain 
relief, and this leads to decreased physical functioning and mobility disability. OA pain is 
characterized by altered pain and sensory processing in the central nervous system similar to 
other chronic pain syndromes. Because pharmacologic treatments can increase adverse events 
among older adults, there is a growing interest in non-pharmacological interventions targeting 
central nervous system pain processing for this population. Specifically, noninvasive brain 
stimulation, such as Transcranial Direct Current Stimulation (tDCS), has received significant 
attention for the treatment of pain in chronic conditions due to its neuromodulatory effect. 
tDCS involves the application of weak direct electric current to the head in a noninvasive and 
painless manner, leading to the modulation of the resting membrane potentials of neurons and 
alteration of the endogenous excitability of the targeted cortical area. This stimulation is 
believed to mediate analgesic effects by modulating pain processing pathways. Also, 
mindfulness-based meditation (MBM) has been shown to improve pain-related brain function 
and alleviate pain in multiple chronic pain conditions. Since tDCS is a noninvasive and safe 
approach to facilitate neuroplasticity, it may enhance the brain’s ability to adaptively reorganize 
in response to other clinical interventions, including mindfulness-based interventions. 
Therefore, we will examine the effect of tDCS paired with MBM in older adults with knee OA 
pain. Our hypothesis is that remotely supervised tDCS paired with MBM at home will decrease 
clinical pain and OA-related clinical symptoms, improve physiopsychological pain processing, 
and increase participant satisfaction with treatment. 
 
 

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2.0 
Lay Summary:  
Provide a brief description of the proposed research using terms that someone who is 
not familiar with the science or discipline can understand. 
Knee osteoarthritis pain is one of the most common pain conditions among people over 
45 and pharmacological interventions do not adequately address this common 
comorbid condition. The proposed study examines an evidence-based 
nonpharmacological intervention targeting pain-related brain function: self- 
administered, remotely supervised transcranial direct current stimulation at home 
combined with mindful-based meditation. This study has the potential to significantly 
improve the self-management of pain, decrease public health expenditures, and 
improve the quality of life for older adults. 
3.0 
Purpose:  
Describe the purpose, specific aims, objectives, questions to be answered, hypotheses, 
and/or primary and secondary study endpoints of this Human Research protocol. 
The purpose of this project is to assess the effect of the self-administered tDCS paired 
with MBM in 200 older adults with knee OA. The specific aims are the following: 
determine the effects of active tDCS paired with active MBM on clinical pain and OA-
related clinical symptoms (specific aim 1); determine the effects of active tDCS paired 
with active MBM on physiopsychological pain processing (specific aim 2); determine the 
effects of active tDCS paired with active MBM on participant satisfaction with treatment 
(specific aim 3). evaluate the effect of MBM paired with tDCS on pain-related brain 
function (specific aim 4); and evaluate the relationship between pain-related brain 
function and pain catastrophizing behavior and OA-related clinical pain (specific aim 
5).The central hypothesis is that remotely supervised tDCS paired with MBM at home 
will decrease clinical pain and OA-related clinical symptoms, improve 
physiopsychological pain processing, increase participant satisfaction with treatment, 
and decrease maladaptive changes in pain-related brain function. The study endpoint is 
4 months, including monthly follow-up telephone assessments for 3 months after the 
completion of intervention. 
4.0 
Funding Information:  
Indicate all sources of funding for the project, including gift funds, departmental 
funds, or other internal funding. For each funder, list the name of the funder, and the 
institutional proposal number or award number you received from Sponsored 
Projects. eIRB tip: For externally funded projects, the institutional proposal or award 
number provided must be linked in the “Study Funding Sources” section in eIRB.  
 
☐ No Funding 
Name of funding source: National Institute of Health (NIH) 
 

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☒ Federal Funding, including flow-through 
federal funding (i.e., NIH, NSF, DoD, etc.) 
Institutional Proposal or Award Number: 5R01NR019051-04  
 
eDoc # (for multi-site projects): NCT04375072 
 
☐ Industry Funding 
Name of funding source:  
 
Institutional Proposal or Award Number:  
 
eDoc #: 
 
☐ Foundation Funding 
  
Name of funding source: 
 
Institutional Proposal or Award Number: 
 
☐ Department Funding 
Name of funding source: 
 
☐ Gift Funding 
Name of funding source: 
 
☐ Other 
Name of funding source: 
 
5.0 
Resources Available to Conduct the Human Research:  
Describe the resources (facilities, time, emergency resources, etc.) available to recruit, 
consent, conduct study procedures, and analyze data. 
This study, funded by NIH, was approved by the IRB at the University of Texas Health 
Science Center at Houston and the IRB at the Florida State University at Tallahassee. On 
this R01 project, all the data will be collected at Dr. Ahn’s laboratory in the UA College of 
Nursing building at a single site and continued from where the study has left off. 
Previous participant data will be compiled from the other previous sites and be used in 
UA. Adequate equipment and resources are available in the Ahn laboratory to carry out 
the procedures and accommodate the personnel described in this proposal. 
 
Processing and Analysis of Imaging Data 
Processing and analysis software will be used to analyze the image data collected within 
this project. This software will not be used for any of the medical purposes listed in the 
International Medical Device Regulators Forum, Software as a Medical Device (SaMD): 
Key Definitions document. In other words, the software will not be used for the purpose 
of: 
• diagnosis, prevention, monitoring, treatment or alleviation of disease, 
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury, 
• investigation, replacement, modification, or support of the anatomy or of a 
physiological process, 
• supporting or sustaining life, 
• control of conception, 

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• disinfection of medical devices, 
• provide information by means of in vitro examination of specimens derived from 
the human body.   
• provide means and suggestions for mitigation of a disease, 
• provide information for determining compatibility, detecting, diagnosing, 
monitoring or treating physiological conditions, states of health, illnesses or 
congenital deformities, 
• be an aid to diagnosis, screening, monitoring, determination of predisposition; 
prognosis, prediction, determination of physiological status. 
Additionally, all software used to process and analyze image data collected during this 
project is used in “Exempted investigations” based on the Code of Federal Regulations 
Title 21 Section 812.2 (c)(3)(iv). In other words, the software 
• is not used as a diagnostic procedure without confirmation of the diagnosis by 
another, medically established diagnostic product or procedure. 
A Medical Device appendix will be submitted for any software used in this project that 
does not satisfy the above requirements. 
 
6.0 
Study Population: 
6.1 Select all the categories of participants included in the research: 
☐ Healthy adults 
☐ Non-English-speaking subjects 
☒ Non-healthy adults 
☐ UA staff/faculty 
☐ Children (under 18 years old) * 
☐ UA students 
☐ Pregnant women, neonates, and/or 
fetuses* 
☐ Banner employees 
☐ Prisoners* 
☐ Refugees 
☐ Native Americans, Alaskan Native, and 
Indigenous Populations* 
☐ Other – please explain: Click or tap here 
to enter text. 
 
☐ Adults unable to consent (i.e., 
cognitively impaired adults) * 
6.2 For each of the above selected categories, describe the inclusion and exclusion 
criteria. Indicate age range, gender, and ethnicity.  
Similar to our previous work, participants who are 50-85 years old will be considered 
eligible if they (1) have symptomatic knee OA based on American College of 
Rheumatology clinical criteria, (2) have had knee OA pain in the past 3 months with an 
average of at least 30 on a 0-100 NRS for pain, (3) can speak and read English, and (4) 

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have no plan to change medication regimens for pain throughout the trial. The age 
range was selected to include a higher proportion of persons with knee OA pain. There 
will be no restrictions on gender or ethnicity. According to American College of 
Rheumatology criteria, participants should meet at least 3 of 6 criteria, including age > 
50 years, experience stiffness, the physical property of being inflexible and hard to 
bend, < 30 minutes in a day, crepitus, bony tenderness, bony enlargement, and no 
palpable warmth. Participants will be excluded if they have any concurrent medical 
conditions that could confound the interpretation of outcome measures, pose a safety 
risk for any of the assessments or interventions, or preclude the successful completion 
of the protocol. Specific exclusion criteria are: (1) history of brain surgery, brain tumor, 
seizure, stroke, epilepsy, or intracranial metal implantation,(2) systemic rheumatic 
disorders, including rheumatoid arthritis, systemic lupus erythematosus, and 
fibromyalgia, (3) alcohol/substance abuse, (4) diminished cognitive function that would 
interfere with understanding study procedures (i.e., Mini-Mental Status Exam score ≤ 
23),  (5) prosthetic knee replacement or non-arthroscopic surgery to the affected knee, 
(6) hospitalization within the preceding year for psychiatric illness, (7) no access to a 
device (e.g., smartphone, computer) that can be used for secure video conferencing for 
real-time remote supervision, and (8) skin or scalp conditions that may be aggravated by 
tDCS stimulation.  
 
Specific inclusion/exclusion criteria for Magnetic Resonance Imaging (MRI) procedures. 
• Participants must be able to tolerate small, enclosed spaces and have no medical 
devices or implants on or in their bodies.  
• On a case-by-case basis, and only if the provenance and safety of the implant can 
be established, individuals with certain implants may be able to undergo an MRI 
scan. Such implants may include, cardiac stents, carotid stents, cardiac valve 
replacements, bone and joint pins and screws, some IUD and birth control 
implants. 
• Participants will be excluded from this study if they have any history of 
pacemakers or pacer wires, open heart surgery, artificial heart valves, aneurysm 
clips, cochlear implants, braces or extensive dental work, implanted electrical or 
mechanical devices, tissue expanders, foreign metallic objects from explosives, 
shrapnel or metalwork fragments, or artificial limbs. Participants will also be 
excluded if they are pregnant, claustrophobic, have tremors or cannot lie still 
for1-2 hours, or weight more than 300 pounds. 
6.3 Describe the total number of subjects to be enrolled locally under this IRB approval. If 
obtaining specimens, specify the maximum number of specimens needed for this 
project.  

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The number of subjects who are expected to be enrolled and screened is 240, and the 
number of subjects needed to complete the research procedures (i.e., numbers of 
subjects excluding screen failures.) is 200. The number of subjects who are expected to 
be enrolled and screened for MRI is 80, and the number of subjects needed to complete 
the MRI procedures is 40. Locally, we will recruit 36 participants in UA. 28 participants 
will be for both the tDCS/MBM and MRI procedures combined and 8 participants will be 
for the tDCS/MBM procedure alone. 
 
7.0 
Recruitment Methods:
7.1 Select the methods used to recruit individuals. 
☒ Email 
☒ Screening of the Electronic Medical 
Record (EMR) 
☒ Face to face 
☐ Social media 
☒ Flyers 
☐ SONA System 
☐ In person presentations 
☐ TV, Radio, Print 
☐ Online advertisements 
☐ Other – please explain: Click or tap 
here to enter text. 
☒ Phone calls 
 
7.2 Explain the recruitment process. Describe how potential subjects will be identified, 
where recruitment will take place, when recruitment will occur, and the methods that 
will be used to recruit individuals.  
Participants will be recruited under the direction of the PI. PI will oversee participant 
screening and recruitment. The study team will hand out study flyers/brochures to 
potential study participants, and those patients who contact the study team for more 
information about the study will be approached by study investigators or trained study 
personnel for further determination of eligibility screening requirements and informed 
consent in-person at a scheduled baseline visit. Coordinators will also recruit through 
the collaboration with the UA Department of Orthopedic Surgery (Department Chair: Dr. 
John Elfar) as a study team.  
Patients will be identified as potential subjects by a co-investigator on the study team 
during consultation for standard of care treatment of their knee pain. The study 
opportunity will be initiated by the treating provider. Only those patients that have 
expressed interest in the study and have agreed to be contacted will be approached by a 
study team member through phone, email, or in-person. The study team will review the 
EMR and confirm eligibility.  

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The consent process will occur during face-to-face discussions with a study team 
member. The informed consent form will be read and reviewed by an approved 
member of the study team and all questions will be answered.  The subject will be given 
ample time to ask questions and review the consent form before deciding about 
participation.  All subjects will provide written informed consent before beginning any 
study activities and all will be given a copy of the signed consent form. 
 
8.0 
 Diversity, Equity, and Inclusion 
8.1 Explain how the research plan (recruitment, study population, data collection, etc.) is 
equitable and represents the demographic makeup for the location in which the 
research will be conducted.    
 
The study will not favor or exclude any group of people outside the exclusionary criteria, 
which are implemented to prevent adverse events within the study to protect 
participants. Study staff will create an open and transparent environment to make sure 
participants are not only well-informed but feel safe when participating in the study. 
 
8.2 Describe whether non-English speaking subjects will be included in the study. If yes, 
please explain how your research team is prepared to meet the needs of the 
population. If not, please explain why non-English speakers will be excluded from the 
study population. 
Non-English-speaking subjects will not be included in the study. The study requires 
patient feedback on levels of pain through various paper surveys and verbal 
communication with tests in the lab. In order to maintain data clarity, subjects will be 
required to speak English as the current staff are not multi-lingual or have translators 
available. 
8.3 What methods will you use to collect demographic information from participants? If 
you will not collect demographic information, please explain why not. 
Demographic information will be obtained through a paper Medical History 
Questionnaire. All participants will complete a thorough questionnaire to collect 
demographic and medical history details, including age, sex, height, weight, duration of 
knee OA, current and past treatments for knee OA, comorbid conditions, and current 
medications. 
 
9.0 
Consenting Process: 
9.1 Indicate the informed consent process(es) and/or document(s) for the study. Check all 
that apply.  

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Written Consent 
☒ Informed Consent (ICF) – written or electronically signed form 
☐ Parental Permission – written or electronically signed form 
☐ Assent (participants under 18) – written or electronically signed form 
☒ Combined ICF/PHI Authorization – written or electronically signed form 
☐ Protected Health Information (PHI) Authorization – written or electronically signed  
☐ Translated Consent/Assent – written or electronically signed form(s) 
☐ Short Consent Form – written or electronically signed form (see guidance on Short Form 
process) 
☐ Debriefing Script or Form – document used to properly inform subjects of the study’s 
purpose when intentionally deceived  
 
Oral/Online/Unsigned Consent  
☐ Informed Consent – oral script/online/unsigned 
☐ Parental Permission – oral script/online/unsigned 
☐ Assent – oral script/online/unsigned 
☐ Translated Consent/Assent – oral script/online/unsigned 
 
Waivers of Informed Consent and/or PHI Authorization 
☐ Waiver of Consent 
☐ Full Waiver of PHI Authorization 
☒ Partial Waiver of PHI for Screening Purposes 
 
9.2 Describe in detail the consent processes checked above, including any waiting period 
for subjects to sign the consent, steps to minimize the possibility of coercion or undue 
influence, and the language used by those obtaining consent. 
Subjects will have the option to participate in either the tDCS/MBM portion of the study 
alone or combined with the MRI scan portion at the start of the recruitment process. If 
the subject decides to participate in tDCS/MBM, an informed consent form will be given. 
There will be additional check box for the subject who decides to participate in MRI scan 
and additional signature will be collected. 
Subjects will participate in the study only after they provide signed consent. 
Participation in this study is completely voluntary. All participants will be informed of 
the nature of the procedures and associated risks. 
The consented subject will be screened for any contraindications to MRI and magnetic 
materials. The investigator or MRI Technologist will explain the MRI system and the scan 
that the subject will take part in. The subject will be asked to lie down on the scanner 
bed. Some part of the subjects’ body may be covered or enclosed within an FDA or UA 

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HSPP approved MRI coil. The subject may be asked to interact with a peripheral system 
such as a button, joystick, or TV system before, during, or after the scan.  
 
Where will the original signed consent and PHI authorization documents be stored?  
The original signed consent and PHI authorization documents will be stored in a locked 
office within a locked cabinet with the keys accessible only to the staff and PI.  
9.3 Acknowledgement of consent form storage. 
☒ I will store original signed consent and/or PHI authorization documents for at least 
6 years past the time the study is concluded. 
☐ For studies involving minors, I will store original signed consent and/or PHI 
authorization documents for at least 6 years after the youngest participant turns 18. 
☐ Not applicable – I am not collecting signed documents. 
 
 
 

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10.0 Research and Data Collection Procedures: 
 
10.1 Select the methods of data collection that will be used in this study (select all that 
apply): 
☒ Anthropometric measures (e.g., height, 
weight, waist circumference, 
etc.) 
☐ Participant observation 
☐ Audio/video recording 
☐ Screening data 
☐ Benign interventions 
☐ Self-health monitoring (e.g., 
pedometers, food diaries, etc.) 
☐ Biological specimens – blood draws 
☒ Surveys – paper 
☐ Biological specimens – clinically 
discarded blood or specimens 
☐ Surveys – internet (including online 
and email-based data collection) 
☐ Biological specimens (urine/feces, 
tissue, saliva, skin, hair, nails, nasal swab) 
☐ Surveys – telephone 
☐ Clinical Data Warehouse (CDW) 
☒ Randomization with control and 
experimental groups 
☐ Cognitive or behavioral measures, 
including daily diaries  
☐ Records – billing 
☒ Data collected using other 
communication/electronic devices (e.g., 
cell phones, pagers, and texting devices) 
☐ Records – educational 
☐ Data previously collected for research 
purposes 
☐ Records – employee 
☐ Deception 
☐ Records – lab, pathology and/or 
radiology results 
☒ Instrumentation, equipment, or 
software not approved by the FDA 
☐ Records – mental health 
☐ Interviews – focus groups 
☐ Records – substance abuse 
☐ Interviews – in person 
☐ Research imaging protocols 
☐ Interviews – virtual/online 
☐ Recombinant DNA 
☐ Medical records review 
☐ Social networking sites 
☐ MRI/ultrasound with contrast 
☐ Stem cells 
☒ MRI/ultrasound without contrast 
☐ Radiation Scans (X-Ray, CT Scans, 
etc.)  
☒ Non-invasive instruments (e.g., external 
sensors applied to the body) 
☐ Other activities or interventions – 
describe: Click or tap here to enter text. 
 

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10.2 Description of research procedures. 
 
Participants who meet eligibility criteria and give informed consent will be randomly 
assigned at a ratio of 1:1:1:1 to one of the four groups: (a) active tDCS paired with active 
MBM (n=50), (b) sham tDCS paired with active MBM (n=50), (c) active tDCS paired with 
sham MBM (n=50), or (d) sham tDCS paired with sham MBM (n=50) using the order of 
entrance in the study and previous randomization list generated via SAS software. The 
randomization will balance the allocation of patients to the study arms with respect to 
distributions of age, race, and sex. tDCS with a constant current intensity of 2 mA will be 
applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 
1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., NY; 6.5 inches long, 3 inches 
wide, 0.7 inches thick) with headgear and 5x7 cm pre-saturated, single use, individually 
packed sponge electrodes. The FDA has ruled that the aforementioned tDCS stimulator 
is a “non-significant risk” device, a requirement for Investigational Device Exceptions. 
The sponge electrodes snap into the custom headgear, which is secured to the 
participant’s head for simple and fail-safe electrode preparation. This single-position 
headgear with clearly labeled sponge markers eliminates room for user error and helps 
conserve accurate and reproducible sponge placement. Participants can only administer 
a stimulation session via the Soterix 1x1 tDCS mini-CT Stimulator device after being 
provided a single-use unlock code by the research staff once proper contact quality is 
achieved (only the on/off button will be adjustable by the study participants; they will 
not be able to adjust the device settings). After the participant enters the unlock code, 
the screen on the device will show a timer that counts down the minutes until the end 
of the session. At 20 minutes, the device will turn off automatically, and study staff will 
instruct the participant to remove the headset and discard the sponges and to safely 
store all materials for the next session. For sham stimulation, the electrodes will be 
placed in the same positions as for active stimulation, but the stimulator will only deliver 
2 mA current for 30seconds. This sham stimulation method has been shown to be 
reliable and indistinguishable from active treatment. During each tDCS session, 
participants will practice MBM. The meditation intervention will be applied 
simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded 
meditation on a CD. Participants will be provided with a CD player and earphones. The 
recording will instruct participants to close their eyes, connect to the openness of one’s 
mind, and mindfully maintain and deepen the connection through breathing with more 
openness and awareness. The sham MBM intervention will be delivered via a CD player 
that will look identical in both active and sham MBM. The sham recording will instruct 
participants to relax and take deep breaths every 3 minutes without the specific 
mindfulness-based instructions (e.g., practicing mindful attention to the breath in a non-
evaluative manner). All other aspects of the sham MBM intervention (e.g., body 
position, time spent listening to instructions, eyes closed) will match the active MBM. 
 
Participants will perform self-administered tDCS and MBM at their home or private 

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room for two weeks (Mondays-Fridays) under real-time supervision by the research 
staff. The research staff will monitor participant for the accurate positioning of the 
headgear, optimized skin contact, proper usage of code to initiate the stimulation, and 
abide with the duration of the stimulation. Data will be collected by study staff across 
several points using equipment and resources available at Dr. Ahn’s (PI’s) laboratory at 
University of Arizona (see Table below). Participants will visit Dr. Ahn’s lab three times, 
and each visit will take approximately 2 hours for tDCS/MBM study and additional 1 
hour for MRI scan. Study team will not conduct a urine or blood pregnancy test. 
Note: B, Baseline; MRI, magnetic resonance imaging; MMSE, Mini-Mental Status Exam, 
NRS, Numeric Rating Scale; WOMAC, Western Ontario & McMaster Universities 
Osteoarthritis Index; fNIRS, functional near-infrared spectroscopy; CPM, conditioned 
pain modulation; FMI, Freiburg Mindfulness Inventory; CESD, Center for Epidemiologic 
Studies Depression Scale; PCS, Pain Catastrophizing Scale; CSQ, Client Satisfaction 
Questionnaire. The baseline visit will occur 3 to 7 days prior to the tDCS intervention. 
*Existing knee radiographs to determine OA severity using Kellgren-Lawrence scores. 

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†On days 5 and 10, tDCS paired with MBM will be delivered at Dr. Ahn’s laboratory, 
followed by data collection of self-report measures (NRS, WOMAC, FMI, CSQ-8 [only day 
10]), and immediately afterwards, the fNIRS and CPM will be collected. 
 
• MRI. MRI will be completed within a week from the baseline visit and the last 
visit. Scans will be conducted at the Translational Bioimaging Resource (TBIR) 
located in UA. Only FDA-approved MRI devices will be used.  
• MMSE. MMSE will be used to exclude people with diminished cognitive function 
(i.e., Mini-Mental Status Exam score ≤ 23). 
• Kellgren-Lawrence Scores. Kellgren-Lawrence scores collected from existing 
patient x-rays will be conveyed from Dr. John Elfar to the research study team. If 
available, we will collect Kellgren-Lawrence Scores or x-rays directly from non-
Banner affiliated participants. The scores will be used in the study to determine 
OA severity.  
• Medical History Questionnaire. All participants will complete a thorough 
questionnaire to collect demographic and medical history details, including age, 
sex, height, weight, duration of knee OA, current and past treatments for knee 
OA, comorbid conditions, and current medications.  
• Clinical pain intensity will be measured by asking participants to rate their 
average knee pain over the past 24 hours via NRS from 0 (no pain) to 100 (worst 
pain imaginable). Following the Initiative on Methods, Measurement, and Pain 
Assessment in Clinical Trials recommendations for clinical trials involving chronic 
pain, pain intensity changes assessed through an NRS will be our primary 
outcome measure for data analysis purposes.  
• We will measure OA-related clinical symptoms using Western Ontario and 
McMaster Universities Osteoarthritis Index (WOMAC), which ranges from 0 to 
96, with higher scores indicating worse OA pain-related symptoms.  
• We will measure pain-related cortical response using a continuous-wave, 
multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan). This 
instrument encompasses 8 light sources (each emitting laser light at 780, 805, 
and 830 nm) and 8 detectors connected to comfortable headgear using optical 
fibers. The illumination and detection optodes will be arranged in a geometrical 
layout that will cover the prefrontal and somatosensory cortex regions 
bilaterally, consistent with locations investigated in previous studies. Optical 
recordings will be collected during thermal and punctate pain stimulation. A 
temperature-controlled pain generator (Medoc TSA- II Neurosensory Analyzer) 
and nylon filament (Touch-Test Sensory Evaluators) will be used to produce 
thermal (maximum temperature of 50 Celsius degree) and punctate pain 
stimulation (maximum force of 300g). We will apply moderate intensity thermal 
and punctate stimuli for approximately 10-20 seconds, just enough time to feel 
the discomfort of the pain stimulation, to the most painful knee during multiple 
scanning runs, followed by an equivalent time period of no stimulation. In this 

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period of time, the fNIRS imaging system will measure the brain activity of the 
participant. 
• A multimodal Quantitative Sensory Testing (QST) battery will be completed for 
Conditioned Pain Modulation (CPM). These measures will be assessed using 
equipment and methods available at Dr. Ahn’s laboratory, including a Medoc 
TSA- II Neurosensory Analyzer, a temperature-controlled pain generator to 
produce thermal pain stimulation to the most painful knee and ipsilateral 
forearm and Wagner pressure algometer to produce pressure pain stimulation 
to the most painful knee and trapezius. We will be applying pressure stimulation 
combined with the participant holding their hand under cold water for one 
minute at most. 
• Psychosocial symptoms will be measured by FMI (ranges from 14 to 56), COVID- 
stress scale (range from 0 to 144), CESD (ranges from 0 to 60), and PCS (ranges 
from 0 to 52). FMI is a 14-item instrument (range, 14 to 56), with higher scores 
indicating more skill with the mindfulness technique. The FMI has a reported 
Cronbach’s alpha coefficient of 0.86. COVID-stress scale, CESD, and PCS are 
commonly used in clinical studies.  
• 
We will measure participant satisfaction with treatment using the Client 
Satisfaction Questionnaire (CSQ-8). The CSQ-8 comprises eight items that are 
summed to yield an overall score of 8-32, with higher scores indicating greater 
satisfaction. The CSQ-8 has a reported Cronbach’s alpha coefficient of 0.87-0.93. 
Moreover, we will evaluate the presence and severity of possible side effects of 
treatment at the end of each session on a 0 (not at all) to 10 (highest degree) 
scale. The participants will be asked in an open- ended manner whether they 
experienced any side effects, and they will complete a brief questionnaire 
assessing side effects that can occur with tDCS or MBM (e.g., itching, headache, 
fatigue, dizziness). This approach has been used in our previous study and 
frequently in other studies. 
 
10.3 Specify the total estimated time commitment for subject participation, and the 
estimated time commitment for each activity. 
We expect that participants will be in this research study for four months. For a two-
week period, participants will perform self-administered tDCS and MBM at their home 
or private room for eight days (Monday – Friday) of 20-minute supervised Zoom 
sessions. There will also be three lab visits lasting two hours each within those two 
weeks: once on the first day, once in the middle of the study, and once during the last 
day. Should they choose to participate, there will be two visits lasting one hour in the 
MRI facility, once before the first lab session and once after the last lab session. Finally, 
we will follow up with participants once a month for three months after the two-week 
period through phone survey for 20 minutes each or having the participant mail their 
paper survey answers to the office.  

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10.4 If any biological specimens (blood, urine, tissue, etc.) are being collected for research, 
state the amount (ml/tsps./tbsp, etc.), method, frequency, and type of specimen to be 
collected and what the specimen will be used for.  
N/A 
10.5 If the study is a clinical trial, confirm registration with https://clinicaltrials.gov/ has 
been completed: 
This study is not a clinical trial: ☐ 
Registration complete: ☒ 
Registration pending: ☐ 
 
11.0 Potential Benefits to Subjects: 
11.1 Describe the anticipated benefits of this study to society, academic knowledge, or 
both.  
The central hypothesis is that remotely supervised tDCS paired with MBM at home will 
decrease clinical pain and OA-related clinical symptoms, improve physiopsychological 
pain processing, increase participant satisfaction with treatment, and decrease 
maladaptive changes in pain-related function. This hypothesis will be tested by pursuing 
the following specific aims: determine the effects of active tDCS paired with active MBM 
on clinical pain and OA-related clinical symptoms (specific aim 1); determine the effects 
of active tDCS paired with active MBM on physiopsychological pain processing (specific 
aim 2); determine the effects of active tDCS paired with active MBM on participant 
satisfaction with treatment (specific aim 3). The proposed research is significant because 
it is expected to provide valuable insight into an exciting new modality of 
nonpharmacological pain self-management that is extremely easy, safe, and noninvasive 
with minimal side effects. 
11.2 Describe any benefits that individuals may reasonably expect from participation (not 
including compensation, which cannot be considered a benefit of participation). 
Brain Stimulation and meditation have been shown to reduce pain in some older adults. 
We cannot promise any benefits to participants in this research. However, this study will 
help us to understand whether self-brain stimulation and meditation will reduce pain in 
older adults with knee osteoarthritis, which might lead to better treatment for people 
with such conditions. 
 

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12.0 Risks to Subjects: 
12.1 Describe all physical, psychological, social, legal, and/or economic risks that could be 
associated with participation in this research.  
• MRI. The MRI environment is cramped and may provoke claustrophobia in some 
subjects. MRIs are associated with repetitive loud noises in the range of 126 – 131 dB on 
a 3T system. The radio frequency (RF) energy deposited in the body during an MRI scan 
can increase body temperature. Proximity burns may arise due to deposition of focused 
RF energy into the body where it touches the bore of the magnet. Known as the 
projectile effect, the strong magnet field can draw in MR-unsafe objects in a rapid and 
uncontrolled manner that can pose a serious threat to the health and life of those in the 
room.   
Significant risks may exist for people with: 
o Cardiac pacemakers 
o Metal clips (stents) on blood vessels 
o Artificial heart valves 
o Artificial arms, hands, legs, etc. 
o Brain stimulator devices 
o Implanted drug pumps 
o Ear implants & augmentation (e.g. cochlear implants, hearing aids) 
o Eye implants, metal fragments in eyes, colored contact lenses 
o Exposure to shrapnel or metal filings (e.g. military combat, sheet metal workers, 
welders) 
o Other metallic surgical hardware anywhere in the body or on the skin 
o Certain tattoos with metallic ink 
o Certain transdermal (skin) patches such as NicoDerm (for tobacco dependence), 
Transderm Scop (for motion sickness), or Ortho Evra (birth control) 
 
Significant risks can also arise if metallic or magnetic objects and materials are 
brought into the scanning area (e.g. jewelry, piercings, pocket knife). Such items 
could get pulled into the magnet at great speed and can cause serious injury. 
 
• tDCS. The Soterix Medical 1x1 tDCS mini-CT Stimulator may cause transient minor 
irritation, discomfort and redness at the electrode sites. tDCS has not been shown to 
cause seizures nor lower the seizure threshold in animals. There are no reports of 
seizure induced by tDCS in human participants in the literature. However, this may not 
be true for epilepsy patients, whose seizure threshold rates are likely abnormal. 
Therefore, potential participants who have a history of seizures or epilepsy will be 
excluded from the study. 
• MBM. The risks of MBM are minimal. Occasionally, participants report transient anxiety 
or mild discomfort during MBM. 

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• Demographic and clinical survey questionnaires. The potential risk of the questionnaires 
involves participants’ feelings of discomfort or unease when reading or responding to 
survey questions that are personal. 
• Thermal stimulation. The Medoc TSA-II Neurosensory Analyzer will be used to create 
thermal stimulation, which will use a heating apparatus that has a low risk of burning 
skin. The TSA-II is covered under FDA 510K #K922052, which has both hardware and 
software safety limits that will not go beyond a certain temperature limit (50 C) in order 
to prevent burning of the skin. 
• Functional near-infrared spectroscopy. Optical fibers will be secured to the participant’s 
scalp using the cap’s grommets. Although there is no designed measure that protects 
the participants from the risk of discomfort due to prolonged wearing of headgear, we 
will assess the participants’ level of discomfort through direct question immediately 
after wearing the headgear and periodically during the experiment. Participants will be 
instructed that they can discontinue the procedure if they experience any discomfort or 
unpleasant effects. 
• Conditioned pain modulation. There are risks of bruising and lingering pain by applying 
gradual pressure stimuliwith the pressure algometer. The participant will tell the 
examiner as soon as  they feel pain or discomfort as pressure gradually increases and 
the examiner will immediately release pressure. We will be doing the same pressure 
stimulation combined with the participant holding their hand under cold water for one 
minute at most. The participant may withdraw their hand from the cold water at any 
time before the minute elapses if the cold pain is too much to bear. 
 
12.2 Discuss what steps will be taken to minimize risks to subjects/data. 
• MRI. To mitigate risks, the following steps will be adopted: The protect the hearing of 
subjects, they will be provided with ear plugs and headphones to lower sound levels to 
no more than 99 dB(A). Adequate ventilation in the MRI bore and a magnet room 
temperature of 20°C will be maintained at all times to ensure subjects can maintain 
body temperature. Blankets will be provided, if necessary. To eliminate the possibility of 
proximity burns, pads will be used to ensure that the subject’s tissues do not directly 
come into contact with the inner bore of the magnet during the MR imaging process. 
Also, for this reason, subjects’ body tissues will not be permitted to form a conductive 
loop. Pads will be used to ensure this cannot happen. Any MR-safe or MR-conditional 
equipment necessary for the conduct of the scan will be introduced into the magnet 
room before the subject to ensure there is no risk to the health and life of those in the 
room due to a potential projectile effect. MR-unsafe objects are never allowed in the 
magnet room. To ensure that subjects can be safely scanned, they will be screened for 
MRI suitability at least three times: once upon prospective enrollment into the MRI arm 
of the study, upon enrollment, and finally on the day of the MRI scan. 

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• tDCS. To minimize risk associated with tDCS, participants will be asked to report any 
discomfort, and the examiner will monitor participants throughout the stimulation 
sessions. All tDCS sessions will be remotely supervised by a trained experimenter. 
Participants may stop at any time. tDCS has not been shown to cause seizures nor lower 
the seizure threshold in animals. There are no reports of seizure induced by tDCS in 
human participants in the literature. However, this may not be true for epilepsy 
patients, whose seizure threshold rates are likely abnormal. Thus, history of seizure is an 
exclusionary criterion for our study. 
• MBM. Participants will be instructed that they can discontinue the procedure if they 
experience any discomfort or unpleasant effects. 
• Demographic and clinical survey questionnaires. Throughout each questionnaire, 
participants will be reminded that participation is completely voluntary, they can refuse 
to answer any question, and they can stop at any time. Breaks will be given if needed. 
Research staff who collect data will have previous training in the conduct of all survey 
questionnaires. 
• Functional near-infrared spectroscopy. Although there is no designed measure that 
protects the participants from the risk of discomfort due to prolonged wearing of 
headgear, we will assess the participants’ level of discomfort through direct question 
immediately after wearing the headgear and periodically during the experiment. 
Participants will be instructed that they can discontinue the procedure if they 
experience any discomfort or unpleasant effects. 
• Thermal stimulation. The following precautions will be employed in the proposed study: 
1) participants will be informed that they can withdraw their arm from the stimulator at 
any time; 2) the experimenter will continuously monitor stimulus temperature and can 
manually discontinue stimulation at any point; and 3) the stimulator has a built-in shut-
down system to prevent the delivery of prolonged or high-intensity stimuli. 
Inconvenience to participants will be minimized by delivering brief stimuli that are 
below the individual's thermal pain tolerance level. The thermal stimulator will start 
generating heat at the temperature less than human body temperature and participants 
will be provided with the button to stop the stimulator the moment they feel discomfort 
or pain. These procedures will ensure maximum patient safety and comfort while 
allowing successful and reliable imaging of the brain. 
• Conditioned pain modulation. The risks of bruising and lingering pain will be diminished 
by applying slow, gradual pressure to the knee and shoulder with the pressure 
algometer, wherein the participant will tell the researcher to stop the moment they feel 
discomfort or pain and the researcher will immediately release pressure. The researcher 
will record the numeric reading on the pressure algometer. We will also be doing the 
same test while the participant’s hand is in ice-cold water. We will let the participant to 
take their hand out of the cold water at any time it becomes too much within the one-
minute time limit and the time of cold withdrawal (in seconds) will be recorded. All the 

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stimulation and testing sessions will be supervised by trained research staff who will 
monitor potential adverse effects and symptoms. At each stimulation session, 
participants will be asked to report any adverse events they have experienced. 
13.0 Costs, Compensation, and Injury: 
13.1 Describe any costs, monetary and non-monetary, that subjects may incur. This 
includes time. 
 
Subjects will not incur any monetary costs. The duration of an individual subject’s 
participation in the study is four months including follow-up phone/survey assessments. 
Any equipment provided will be paid for by the study. 
 
Discuss the amount of compensation (monetary and/or non-monetary) subjects may 
receive. Describe if compensation will be prorated. 
 
Subjects will receive up to $220 in gift cards for completing the main protocol, and they 
will receive partial payment if they do not complete the entire study. For each self-brain 
stimulation and meditation, subjects will receive $10 and an additional $30 for each visit 
to our testing center and $10 for each follow-up phone assessments. Additionally, 
participants who complete MRI visits will be compensated with up to $200 ($100 for 
each MRI data collection visit X 2 times). 
 
14.0 Privacy of Subjects and Confidentiality of Data: 
14.1 Describe steps, if any, to protect the privacy of the subjects throughout their 
participation (e.g., during the recruitment process, consent process, and/or research 
procedures). 
 
A number of data integrity procedures will be used to ensure the validity and integrity of 
the data and the safety of all participants involved in the study. All procedures involving 
human participants will be performed at the PI’s laboratory at UA College of Nursing. 
Relevant data and safety information obtained from each study participant will be 
verified against the original source documents by the study coordinator, and any 
identified discrepancies will be reviewed at the weekly meetings. All identifying 
information will be archived on a password-protected server in password-protected 
folders and files. Only study staff will have access to these files. We will use the double 
data entry module in REDCap for self-report data (e.g., questionnaires).  
 
Computer-generated reports of variable frequencies and participant lists will be 
reviewed, leading to possible corrections to coding or entry. After data within a given 
group are checked for accuracy, the data will be stored in the password-protected 

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folders. 
 
Adherence to the study protocol will be promoted throughout the trial. Of note, the 
research team will receive proper training using detailed manuals of procedures for all 
aspects of the proposed research, including treatment protocols and participant 
interaction, in a step-by-step fashion. All study personnel will be trained before study 
initiation, and the PI will carry out weekly supervision of the research team’s adherence 
to protocols. These procedures were successfully implemented in our previous studies. 
14.2 Will data be kept for future research, including unspecified future research and 
genetics?       Yes ☐     No☒ 
 
14.3 If yes to the above question, describe future use plans here including any storage in a 
repository (if applicable), and what data will be retained/reused.  
N/A 
14.4 Discuss how study results will be shared with subjects, families, and/or the institution, 
both immediately and long-term. 
We will publish research results at the peer-reviewed journal and/or scientific 
conferences. After completion of the study, results may be shared to research subjects if 
they want. Subjects will be provided with copies of their MRI data upon request.  
The information provided in the study will be handled confidentially. However, there 
may be circumstances where this information must be released or shared as required by 
law. The University of Arizona Institutional Review Board; other federal, state, or 
international regulatory agencies; or the sponsor of the study, if any, may review the 
research records for monitoring purposes. 
 
We may publish the results of this research. However, we will keep participant names 
and other identifying information confidential to the extent allowed by law. A 
description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify 
participants. At most, the Web site will include a summary of the results. Participants 
can search this website at any time. 
14.5 Indicate if the research team will be accessing any of the following records.  
☐ Substance abuse records (HIPAA and 42 CFR Part 2) 
☒ Medical records (HIPAA)  
☐ Educational records (FERPA)* 
☐ Employee records (ABOR Policy 6-912)* 
☐ Other, specify: Click or tap here to enter text. 

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14.6 For each record source selected above, summarize the data elements to be accessed, 
who will access them, and how the information will be obtained. 
Kellgren-Lawrence scores will be obtained from existing radiographs only accessible by 
the Dr. John Elfar. Kellgren-Lawrence scores will be obtained from the Dr. Elfar only 
after written consent has been signed. The Kellgren-Lawrence scores will be stored in 
REDCap for security and transmitted to Dr. Miao, our biostatistician in FSU. 
 
14.7 Indicate where data will be stored: 
☐ Box@UA 
☐ OnCore 
☒ Box@UA Health 
☐ PACS medical imaging software 
☐ Clinical Data Warehouse (CDW) 
☐ Password Protected Drive 
☐ Cloud Server  
☒ REDCap 
☐ Department Drive 
☐ Transmitting/receiving subject data 
to/from an outside group 
☒ Department Office 
☐ UA Records Management & Archives 
☐ Encrypted Drive 
☐ Banner Server/Platform, specify:  
☐ External Drive (hard drive, USB, disk) 
☐Soteria  
☐ Google Suite for Education 
☐HIPAA Research Computing Service 
☐Other, specify: Click or tap here to 
enter text. 
 
 
14.8 For EACH of the storage locations checked above, discuss the type of data to be 
stored, including if the data is identifiable, coded, or de-identified upon storage, and 
who may have access to the data. 
Only trained research team members designated in the IRB- approved study protocol 
will collect data. REDCap (http://www.project-redcap.org) will be used to capture and 
store participant data, accessible only by research team members via an encrypted and 
password-protected computer. All research data will be coded using the participant’s 
unique identifier. No name or other identifying information will be used on research 
data. All paper data (e.g., participant contact information, consent forms) will be placed 
in a locked file cabinet in a locked office within 24 hours of their acquisition. All data 
files will be automatically backed up daily on Box@UA Health. We will ensure data 
changes are documented and there is no deletion of entered data. Data will be 
accessible only by research team members via an encrypted and password-protected 
computer, and we will prevent unauthorized access to data. The code will be 

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maintained on Box@UA Health and will be destroyed after 3 years following closeout of 
a grant of contract agreement by the research team. 
14.9 Storage of research records (research records should be maintained for whichever of 
the following time periods is the longest, select one): 
☒ I will store research records for at least 6 years past the time the study is 
concluded. 
☐ For studies involving minors, I will store research records for at least 6 years after 
the youngest participant turns 18. 
☐ I will store research records for the length of time required by law or study 
sponsor, please specify:  Click or tap here to enter text. 
 
14.10 Describe what security controls (e.g., administrative, physical, technical) are in place 
to make sure data/specimens are secure.  
 
A number of data integrity procedures will be used to ensure the validity and integrity of 
the data and the safety of all participants involved in the study. All procedures involving 
human participants will be performed at the PI’s laboratory at UA College of Nursing. 
Relevant data and safety information obtained from each study participant will be 
verified against the original source documents by the study coordinator, and any 
identified discrepancies will be reviewed at the weekly meetings. All identifying 
information will be archived on a password-protected server in password-protected 
folders and files. Only study staff will have access to these files. We will use the double 
data entry module in REDCap for self-report data (e.g., questionnaires).  
 
Computer-generated reports of variable frequencies and participant lists will be 
reviewed, leading to possible corrections to coding or entry. After data within a given 
group are checked for accuracy, the data will be stored in the password-protected 
folders.  
 
Adherence to the study protocol will be promoted throughout the trial. Of note, the 
research team will receive proper training using detailed manuals of procedures for all 
aspects of the proposed research, including treatment protocols and participant 
interaction, in a step-by-step fashion. All study personnel will be trained before study 
initiation, and the PI will carry out weekly supervision of the research team’s adherence 
to protocols. These procedures were successfully implemented in our previous studies. 
 
14.11 Indicate how data/specimens will be shared with collaborating entities: 

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☐ Data and/or specimens will not be shared between UA and any outside group or 
collaborating entity. 
☒ Data/or specimens will be transmitted and/or disclosed to an outside group or a 
collaborating entity. 
☐ Data and/or specimens will be received from an outside group or a collaborating 
entity.  
☐ PHI will be transmitted to or received from an outside group or a collaborating 
entity. * 
☐ A Limited Data Set will be transmitted or received from an outside group or a 
collaborating entity. * 
☐ Data/specimens will be sold to pharmaceutical companies. 
 
Describe what information will be shared, who it will be shared with, and how it will 
be shared (e.g., secure file transfer, REDCap, etc.). Also include information about 
future use sharing and repositories Specify if the shared data will be identifiable, 
coded, a limited data set, or de-identified. 
 
Dr. Hongyu Miao, the study statistician, will coordinate data management and analysis. 
Coded participant personal data and questionnaire data will be shared with Dr. Miao 
through REDCap. Dr. Miao will not have access to the code key but will have access to 
other personal information such as age, gender, etc. Kellgren-Lawrence scores, the 
numbers defining severity of osteoarthritis, will be shared with Dr. Miao once the 
scores, not the x-rays, are obtained from Dr. Elfar. Dr. Miao will also have access to all 
questionnaire results (CPM test results, MRI data, etc.) to compile into data. DUA for 
sending data to Dr. Miao is in progress and no PHI is being shared with external 
collaborators. 
 
15.0 Additional Questions (complete as applicable): 
15.1 Subject Injury: If the research involves more than minimal risk to subjects, describe 
the provisions for medical care and available compensation in the event of research 
related injury. If the Human Research has a clinical trial agreement, this language 
should reflect what is stated in the agreement. 
15.2 This study poses minimal risks because (1) the discomfort is transient in nature and 
generally subsides immediately after the procedure; (2) participants are instructed that 
they may stop any procedure at any time with no adverse consequences; and (3) the 
level of discomfort experienced by participants is below their tolerance level. Also, risks 
will be minimized by adhering to our exclusion criteria, and the Dr. Elfar will have full 
discretion to exclude participants who may be at excessive risk through thorough review 
of all tDCS cases prior to any procedure. A standard operating procedure has been 

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outlined in case of medical emergency or adverse event and the responsible physician 
as well as the PI will be available by phone during all cases. Only research personnel 
with the relevant background, training, and expertise will be able to follow the lab 
procedures.Withdrawal of Subjects: Discuss how, when, and why subjects may be 
removed from the study.  If abrupt withdrawal is necessary, discuss how subjects will 
be withdrawn so that they are not put at increased risk. Discuss what happens if a 
subject is withdrawn from one part of the study but asked to continue with other 
parts, such as ongoing follow-up. 
Participants will be informed that they can withdraw from the study at any time by 
calling study team at 520-626-6863 and that this will have no adverse impact on the 
study or on their own future medical treatment. A subject withdrawn from the study 
will not be asked to continue with other parts of the study. Data collected prior to 
withdrawal will be retained. 
15.3 Monitoring for Subject Safety: Provide a brief lay discussion of your plan to monitor 
for subject safety. Describe what safety information will be collected, including serious 
adverse events, how safety information will be collected, and the frequency of 
collection including a timeline of when the data and review(s) will occur, who will 
review the information, and the plan for reporting findings.  
If there will not be a way to monitor for subject safety, please explain. 
The Safety Monitoring Committee (SMC), which was approved by NIH, will be 
responsible for overseeing activities related to implementing the clinical trial to ensure 
patient safety, conformance to the clinical protocol, overall performance of the trial 
components, and integrity of the data being collected. The SMC will meet prior to the 
start of enrollment and then annually to review study progress (e.g., recruitment, 
retention, and safety procedures) and participant safety concerns and as needed to 
adjudicate any adverse events. All meeting materials will be considered privileged by 
SMC members. The SMC will comprise 3 members with expertise in neuromodulation, 
statistics, and geriatric clinical research: Ricardo Jorge, MD, professor of psychiatry and 
behavioral sciences at Baylor College of Medicine;  Hongyuan Cao, PhD, associate 
professor at the Florida State University Department of Statistics; and Jessica Lee, MD, 
Assistant Professor, Geriatric and Palliative Medicine, UTHealth McGovern Medical 
School. The SMC members are independent of the project. These members are 
appropriately qualified to review the scientific design and conduct of the study, to 
evaluate safety and risks to participants, to interpret data statistically, and to make 
recommendations concerning the continuation, modification, suspension, or 
termination of the study. 
The research MRI scanner operates within FDA guidelines and is considered a non-
significant risk device. This means the risks are minimal so long as appropriate 
precautions are taken. The Siemens MRI scanner that will be used for scans is approved 
by the FDA for routine clinical and research studies. This is also true for most of the 

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peripheral components used with the scanner as well as most of the scan types that are 
performed on the scanner. However, as part of the sessions we may use non-FDA-
approved components, scans, and/or software. In all cases these components, scans, 
and software comply with all FDA guidelines with respect to MRI safety. 
15.4 Data Management Plan: Please discuss the data management plan, if required by your 
funder. For additional resources, reference the HSPP Data Management webpage. If 
your sponsor/funding agency requires a Data Management Plan, please upload the 
approved copy in eIRB.  This section and the informed consent form should contain all 
pertinent information including:  
• What data/metadata will be shared (imaging, survey; raw data or derived; 
protocol, data form; etc.) 
• What repository will be used (if known) 
• How will data be stored (in a de-identified or identifiable format)  
PI has substantial experience in the design and implementation of data management 
procedures that provide accurate recording and storage of data, participant 
confidentiality, and timely analysis. Based on our experience, we believe that the 
major data management and analysis needs for the proposed project can be met by 
using a high-end PC, equipped with SPSS and SAS for Windows and appropriate 
spreadsheet programs. All data files will be automatically backed up daily.  
The data entry system will require a login identification and password to gain access 
to the data. Where appropriate, validation and range rules will be applied to the 
actual entry fields. Only the PI and designated research staff will be able to view the 
data in its raw state.  
Participant data will be coded. Confidentiality will be protected by assigning each 
participant a number, which will be used in all data tabulation and subsequent 
publications. The list linking this number to the participant’s identity will be 
maintained in a password-protected data file, accessible only by authorized research 
personnel associated with the human testing components of this project. The PI will 
oversee the compliance of the study, maintaining strict adherence to the 
requirements of the law, research protocols, and health information security. Only 
trained research team members designated in the IRB- approved study protocol will 
collect data. REDCap (http://www.project-redcap.org) will be used to capture and 
store participant data, accessible only by research team members via an encrypted 
and password-protected computer. All research data will be labeled using the 
participant’s unique identifier. No name or other identifying information will be used 
on research data. All paper data (e.g., participant contact information, consent 
forms) will be placed in a locked file cabinet within 24 hours of their acquisition. 
 

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15.5 International Research: Describe site-specific regulations or customs affecting the 
research, local scientific and/or ethical review structures that differ, and if community 
advisory boards are involved. If so, describe their composition and involvement. For 
research being conducted outside of the US, please explain any local laws, regulations, 
or customs the IRB needs to be aware of.  
N/A 
 
 

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Additional items needed for review: 
• Word versions of applicable subject materials: Consents, PHI Authorization Form(s), 
Recruitment Materials, Data Collection Materials, additional Participant Materials 
• Current PI CV or biosketch 
• Advisor approval (if the PI is a student or medical resident) 
• Department/Center/Section Review approval 
• Scientific/Scholarly review approval  
• Responsible physician approval and CV (if the PI is conducting medical procedures for 
which he/she is not clinically certified to perform) 
• Additional approvals, as needed (e.g., RIA/Banner feasibility, Export Control, Radiation, 
COI, UA travel registry, CATS, SRC, school district approval, tribal approval, etc.)  
 
Other items as applicable: 
• HSPP Appendices 
• Data Monitoring Charter and Plan  
• Drug/Device information 
o Applicable drug or device appendix 
o Investigator's Brochure, drug product sheet, device manual, user's manual, 
instructions for use, package insert, IND/IDE documentation, FDA 1572 form, 
510k indication, FDA exemption, sponsor determination of device risk, etc. 
• Multi-site information (for sites engaged in research where the UA is the IRB of record)  
o Appendix for Multi-Site Research for each site 
o Documentation of reliance  
o CV and medical license (if applicable) of site PI 
o Human Subject Training Verification for site PI and site staff 
• Sponsor protocol and MOPs that are used in the study (if applicable)