Noninvasive Modulation of Motivational Brain Regions in Healthy Volunteers
Phase: NA
Conditions: Traumatic Brain Injury
Sponsor: University of New Mexico

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PROTOCOL TITLE: NONINVASIVELY MODULATING MOTIVATIONAL BRAIN 
REGIONS 
PROTOCOL TITLE: Noninvasive modulation of motivational brain regions in 
healthy volunteers. 
 
 
PRINCIPAL INVESTIGATOR: 
Jeremy Hogeveen, PhD 
Department of Psychology 
Email: jhogeveen@unm.edu 
 
ADMINISTRATIVE CONTACT: 
Ethan Campbell 
Department of Psychology 
Email: ecampbell@unm.edu 
 
VERSION NUMBER: 
v. 04/20/2023 
DATE: 
04/20/2023 
REGULATORY FRAMEWORK: 
Please indicate all that apply: 
 
 
 
DOD (Department of Defense) 
 
 
DOE (Department of Energy) 
 
 
DOJ (Department of Justice) 
 
 
ED (Department of Education) 
 
 
EPA (Environmental Protection Agency) 
 
 
FDA (Food and Drug Administration) 
 
 
HHS (Department of Health and Human Services) 
 
 
VA 
 
 
Other: 
 
Is this a clinical trial under ICH-GCP E6? 
Yes 
No 
If yes, please confirm that the research team is familiar with and agrees to comply 
Yes 
No 
with the investigator requirements cited in ICH-GCP E6. 
ICH-GCP E6 can be accessed by copying and pasting this URL into your 
browser: http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf 
 
FUNDING: P20 GM109089 06 – Sub#6857 

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1. Objectives 
1.1. Describe the purpose, specific aims, or objectives. 
 
The purpose of the proposed research is to develop a novel, precise, and 
individualized approach to modulate motivational neurocircuits in order to ameliorate 
apathy in traumatic brain injury (TBI). Recent work by the PI and collaborators 
suggests that damage to ventromedial prefrontal cortex (vmPFC) or dorsal anterior 
cingulate cortex (dACC) can cause elevated apathy in patients with TBI. 
Additionally, the PI and collaborators at the Center for Brain Recovery and Repair 
(CBRR) recently found that heightened connectivity between these structures may 
provide a compensatory response, reducing apathy in the wake of a TBI.. We are 
currently conducting a related study using task-evoked fMRI to determine the 
specific neural computations that may be encoded in vmPFC-dACC circuits during 
motivated decision making in patients with TBI (#19-053), and the present protocol 
represents a separate but related line of research designed to use precise fMRI-guided 
transcranial magnetic stimulation (TMS) to stimulate vmPFC-dACC circuits and 
modulate motivated behavior in healthy controls (HCs). The purpose for this project 
is clear: fMRI-guided TMS could represent a viable approach for treating apathy in 
TBI, but achieving this goal requires a better understanding of the effectiveness of 
fMRI-guided TMS approaches for engaging those circuits. We will achieve our 
overall objective through the following specific aims: 
 
i) 
To measure individualized patterns of vmPFC and dACC activation and 
connectivity during task-evoked fMRI. 
ii) 
To use these activation patterns to guide brain stimulation using TMS. 
iii) 
To measure TMS-induced changes in brain activation and connectivity 
using fMRI. 
 
1.2. State the hypotheses to be tested. 
i) 
dACC TMS will modulate motivated decision making. 
ii) 
dACC TMS will increase post-TMS recruitment of the brain networks 
underlying motivated behavior. 
 
2. 
Background 
 
2.1. Describe the relevant prior experience and gaps in current knowledge. 
TBI is a common and impairing acquired neurological disorder caused by a 
concussive event to the head. Psychiatric disorders associated with impaired 
decision making–namely, compulsivity, depression, and impulsivity–are common 
symptoms post-injury in TBI. Despite the critical importance of diagnosing and 
characterizing psychiatric problems in TBI, very little is known about the 
neuropathologies underlying psychiatric symptoms in this patient group. 

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Reinforcement learning (RL)–i.e. the process of learning the reward value of 
stimuli and actions–represents a fundamental cross-species construct underlying 
motivated decision making. Further, aberrant RL and reward processing more 
broadly have been strongly implicated in symptoms of compulsivity, depression, 
and impulsivity in the field of computational psychiatry28-30. Despite extensive 
evidence that brain injuries can lead to maladaptive motivated decision 
making31,32, the specific RL aberrations that might underlie this phenomenon, and 
their association with psychiatric sequelae remain unclear. Therefore, extant work 
has failed to provide insight into the computational mechanisms underlying 
maladaptive decision making in patients with TBI, and such work will be critical 
to build a better understanding of the neuropathologies that underlie psychiatric 
sequelae in TBI. This gap in current knowledge is being targeted by our related 
protocol #19-053. 
 
However, even if we have a better understanding of the RL neural mechanisms 
that cause aberrant motivated behavior and psychiatric sequelae in TBI, how to 
translate this into an actionable target for clinical intervention remains unclear. 
Psychological interventions including Cognitive-Behavioral Therapy (CBT) and 
Motivational Interviewing (MI) have been investigated for treating symptoms of 
TBI. Early trials suggest that CBT fails to show a beneficial effect on its own8, 
but when delivered alongside MI–an approach designed to reduce patient apathy– 
a modest reduction is observed9. However, the potential benefit of both CBT and 
MI is limited in TBI, as they both rely heavily on high-level cognitive abilities– 
e.g. selective attention, executive control, and metacognition/insight–that are 
commonly impaired in this clinical population10. In addition to psychotherapies, 
two categories of pharmacotherapy have been investigated to reduce psychiatric 
sequelae in TBI: selective serotonin reuptake inhibitors (SSRIs) and dopamine 
agonists. A randomized controlled trial of SSRIs for TBI failed to demonstrate 
reductions in patient neuropsychiatric symptoms after a 10-week intervention11. 
Multiple pilot studies (Ns=10-11) of dopamine agonists for TBI have been 
conducted, demonstrating preliminary support that they may reduce apathy12,13. 
Yet, a recent meta-analysis suggested a high degree of unreliability in the 
literature on dopamine agonism in TBI14. Dopamine agonists also carry the risk of 
significant side effects including increased apathy15 or maladaptive impulsivity16. 
Unreliability and maladaptive side effects of dopaminergic medications are likely 
driven by their lack of circuit-specificity17: They modulate dopaminergic tone 
throughout the brain, rather than within a dedicated neural circuit underlying a 
specific symptom profile. Therefore, a more effective approach to treating apathy 
in TBI may involve both i) avoiding therapies that rely on high-level cognition, 
and ii) establishing circuit-specific approaches for ameliorating patient apathy. 
Precise fMRI-guided TMS represents one possible approach. The current project 
aims to test the efficacy of fMRI-guided TMS to RL neural circuits anchored in 
dACC on motivated decision making in HCs. Ultimately, the hope is that this 
approach might represent a first step towards a potential clinical intervention for 
TBI patients with clinical apathy. 

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2.2. Describe any relevant preliminary data. 
The PI has previously published on how damage to ventromedial prefrontal cortex 
(vmPFC) can cause significant apathy in patients with traumatic brain injury32. 
Additionally, the study team recently leveraged extant data available in the center 
to demonstrate that enhanced connectivity between vmPFC and dorsal anterior 
cingulate cortex (dACC) represents a potential compensatory mechanism for 
reducing apathy in the wake of a mild TBI injury63. This dACC target, and 
enhanced dACC-vmPFC connectivity, will represent the critical targets for TMS 
neuromodulation in the current study. 
 
2.3. Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how will it add 
to existing knowledge. 
 
Dopamine agonists have demonstrated limited efficacy for ameliorating apathy 
in TBI, but they have significant side effects because they are circuit-general 
(e.g. modulate dopaminergic tone across the brain). Conventional repetitive TMS 
(rTMS) can induce circuit-specific changes, but its rate limiting factor is the 
method used to determine the target region of interest (ROI). In contrast, task 
fMRI-guided rTMS has the potential to enable localization of a circuit relevant to 
a specific symptom, and selective enhancement of excitability in that circuit. The 
rationale for this approach is that, while fMRI-guided rTMS is an established 
method for making causal brain-behavior inferences19,57,58, its therapeutic 
potential for circuit-specific neuromodulation has not been fully realized. 
 
3. Study Design 
3.1. Describe the study design (e.g., observational; randomized placebo-controlled 
clinical trial, etc.) 
 
This is a brain stimulation / HC arm of an existing protocol (#19-053). The 
current protocol describes a clinical trial where we will focus on the causal effect 
on decision-making of rTMS targeting dACC using a fully randomized, within-
subjects, sham- controlled experimental design. 
 
4. Inclusion and Exclusion Criteria 
4.1. Describe how individuals will be screened for eligibility. 
• Participants will be phone-screened to determine their eligibility, and the 
phone screen and script are provided in Appendices 1–2. 
 
4.2. Describe the criteria that define who will be included or excluded in your final 
study sample. 

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• The protocol will recruit male and female adults (18-55 years old) of any 
ethnic background. All recruited participants will be capable of providing 
informed consent. 
• Participants will have 12 or more years of education and the ability to provide 
informed consent independently. 
• Exclusion criteria will be: any condition that would prevent the subject from 
being able to complete the protocol, prior history of neurological disease or 
any history of seizures (including prior history of TBI; i.e., any loss of 
consciousness ≥1 minute), not fluent in English, any contraindications to MRI 
or TMS (Appendices 3-4), history of substance abuse (excluding moderate 
alcohol or marijuana usage), a medical diagnosis of psychosis or mania, or 
stable doses of antipsychotics or mood stabilizers taken for less than two 
months. 
• Participants who are found to have falsely represented any factors which 
should exclude them from the study, or who are unable to follow the study 
protocols for study session attendance may be withdrawn prematurely form 
the study. 
• To reduce the possible spread of COVID-19, during the SARS-CoV-2 
pandemic any participants who answer “yes” to any of the items in Question 
34 of the Phone Screen (Appendix 1) will be excluded from the study at this 
time. 
 
4.3. Indicate specifically whether you will include each of the following special 
populations: (You may not include members of the above populations as subjects 
in your research unless you indicate this in your inclusion criteria.) 
The study will not recruit from the following special populations: adults unable 
to consent, individuals who are not yet adults, pregnant women, or prisoners. 
4.4. Indicate if you excluding any particular populations (e.g., women, children, 
persons not fluent in English, a particular racial or ethnic group, etc.) and 
provide justification. 
Individuals not fluent in English will have difficulty performing the behavioral 
assays used in the current protocol, and will find it difficult to understand the 
study protocols to the point where they are capable of providing truly informed 
consent. Accordingly, proficiency in the English language is a requirement for 
the current protocol. 
 
5. Number of Subjects 
5.1. If this is a multicenter study, indicate the total number of subjects to be accrued 
across all sites. 
N/A – This is a local single-site protocol. 
5.2. Indicate the number of subjects to be recruited at this site. 

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42 HC participants will be recruited. 
5.3. Provide sample size justification 
Prior studies using fMRI-guided TMS to modulate task-related neural 
computations have observed effect sizes of approximately d≈1.0267-69, requiring 
a sample of N=17 per stimulus condition. Therefore, even if a high attrition rate 
of 20% is factored into the current study protocol, the protocol will achieve an 
adequate sample size to detect true differences as a function of stimulation 
condition. 
6. Study Timelines 
6.1. Describe: 
Participants recruited for the study will be invited to complete three experimental 
sessions as soon as it is convenient for them to come in. The three experimental 
sessions will include one MRI scan (1-2 hours per scan). The first session will 
include all questionnaires and assessments (maximum time: 170 minutes, see 
Table 1). The second and third sessions will include rTMS administration 
including motor thresholding (≈20-40 minutes), neuronavigation (≈10-20 
minutes) and rTMS delivery (≈3-20 minutes, depending on the specific pulse 
sequence). The total rTMS session will last ≈1-1.5 hours, and will be immediately 
followed by an MRI scan (total session time: 3-4 hours for day 1, 4-5 hours for 
day 2). It is expected that data collection targets will be reached by September, 
2022. 
 
7. Study Endpoints 
7.1. Describe the primary and secondary study endpoints. 
The study will end when N=42 HC have completed the protocol. 
7.2. Describe any primary or secondary safety endpoints. 
N/A – The study is minimal risk and no safety endpoints are necessary. 
7.3. Describe any exploratory endpoints. 
N/A – The study design does not include any exploratory endpoints. 
8. Research Setting 
8.1. Describe the sites or locations where your research team will conduct the 
research. 
The study will be conducted in Domenici Hall on the UNM North Campus, at the 
Mind Research Network (MRN) also located in Domenici Hall, and in the 
Department of Psychology at Logan Hall on the main campus. 
 
8.2. Identify where your research team will identify and recruit potential subjects. 
All participants will be recruited from the community and from study 19-053: 
Reward-guided decision making in patients with moderate-to-severe traumatic 
brain injury (msTBI), who were contacted via the following strategies: 

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i) Participants who have participated in previous studies at the CBRR 
and consented to be contacted for future research opportunities. 
 
ii) Fliers posted in the community and online (Appendices 5-7), and 
word of mouth. 
 
8.3. Identify where research procedures will be performed including any laboratory 
analytics 
Analytic procedures will be conducted at the MRN, CBRR, and Logan Hall. 
8.4. Describe the composition and involvement of any community advisory board 
N/A – There is no community advisory board. 
8.5. For research conducted outside of UNM HSC and its affiliates describe: 
There will be no research conducted outside UNM / HSC / MRN. 
9. Resources Available 
9.1. Describe the qualifications of the PI and study staff (e.g., training, experience, 
oversight) as required to perform the research. When applicable describe their 
knowledge of the local study sites, culture, and society. 
The PI has extensive experience studying affective and reward processes in HC 
and patients with TBI32,38–40. The PI also has experience with fMRI: The PI has 
experience running the MRI scanner and preparing a diverse range of subjects to 
be scanned, been first author on two peer-reviewed manuscripts using fMRI41,70, 
and has completed both a week-long fMRI course at the Harvard-MIT Martinos 
Center for Biomedical Imaging, and a three-day fMRI course at the MRN. The 
PI has also published several papers using TMS64-66, containing a total of 95 
safely-completed TMS sessions, and recently completed an extensive hands-on 
refresher course on the safe and efficient administration of TMS protocols in 
Mark George’s world-class brain stimulation laboratory in the Department of 
Psychiatry at the Medical University of South Carolina (Appendix 8).Therefore, 
the PI is well qualified to lead the current research protocol. 
All study personnel will have been trained and certified in safe MRI practices at 
MRN, and will have received required training sessions in order to gain access to 
the UNM Noninvasive Neurostimulation Lab (PI: Dr. Davin Quinn). 
Dr. Campbell oversees all projects being conducted at the Clinical 
Neuropsychology Research Core within the CBRR, and is well qualified to 
advise the PI while the current project is being carried out. Finally, the entire 
study team (including all research assistants) have completed the required CITI 
training modules, and have experience collecting behavioral and neuroimaging 
data from human participants. 

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9.2. When applicable, describe which licensed physicians/providers will be 
responsible for medical decision-making and ordering and evaluation of 
necessary diagnostics and therapeutics. 
Within 24 hours, the Beck Depression Inventory (BDI) will be examined for 
endorsement of suicidal ideation. If the participant endorses suicidal ideation 
(scoring 2 or 3 on item #9 of the BDI) the PI will be immediately notified. The 
participant will then be contacted over the phone by a senior member of the 
research team. This protocol will be done in consultation with attending 
psychiatrists at the UNM Psychiatric Center. 
This phone screen protocol consists of multiple steps to protect participant 
confidentiality: 
1) The experimenter will verify via person-to-person contact with 
the participant that this is a “good time to talk discreetly” prior 
to raising the reason for the call about the depression rating 
score for suicidality. 
2) If the participant endorses thoughts of suicidality they will be 
notified of number of local counseling and psychiatric 
resources, including 24-hour hotlines and free or low-cost 
counseling services. 
3) If the participant endorses imminent suicidal ideation, the PI 
will call 911 to inform emergency responders of the 
participant’s location and imminent suicide plans. 
 
Additionally, all research MRI scans at MRN will be read for incidental findings 
by a radiologist. 
 
9.3. Describe other resources available to conduct the research: For example, as 
appropriate: 
A waiting area with a dedicated front desk staff member will greet the participants 
when they arrive at the CBRR. For administering the pre-MRI behavioral practice 
tests, five private testing rooms are available for participant visits at the CBRR. 
The MRI scanning facility is in close proximity to the CBRR testing facilities in 
the MRN portion of Domenici Hall. The scanning facility provides MRI- 
compatible scrubs for each participant. 
With respect to equipment, a PC laptop will be available for running pre-MRI 
behavioral practice tasks at the CBRR. At the MRN, MRI scans will be carried 
out on a 3T Siemens MRI scanner using a 32-channel head coil. TMS will be 
conducted at the Psychiatric Neuromodulation Laboratory on the 2nd floor of the 
Center for Psychiatric Research, in Domenici Hall on the UNM Campus. 
10. Prior Approvals 
The UNM Main Campus Office of the Institutional Review Board has reviewed 
the protocol and agreed to defer review of the application to the UNM-HSC 

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Human Research Protections Office. The current protocol represents the HC arm 
of a separate protocol that has been approved by the HRPO (#19-053). 
11. Multi-Site Research 
N/A – The current protocol is a single-site study. 
 
12. Study Procedures 
The study will be conducted in three 3-6 hour sessions which can be arranged to 
accommodate participants’ schedules. The three sessions will take place with no 
less than 24 hours, and no more than two weeks apart between each study visit. 
Approximately 24 hours prior to the scheduled date, the participants will receive 
an email and a phone call including important information for them to be aware 
of prior to coming in for the study (Appendix 9). An IRB-approved member of 
the research team will greet participants, and will go through the study consent 
procedures. 
SARS-CoV-2 related note: For the duration of the SARS-CoV-2 pandemic, 
consent procedures will be completed remotely via a HIPAA-compliant Zoom 
account or phone call, with participants receiving the document via email. They 
will then sign the consent document when they appear in person for their study 
visit. A note to file will be created for each consent signed in this way. 
Additionally, for the duration of the visit the participant and experimenter will 
remain physically-distanced as much as possible, will both be wearing face 
coverings, and the experimenter will also be wearing a laboratory coat to reduce 
the risk of SARS-CoV-2 spread through droplets. During the TMS protocol, an 
acrylic divider will be used whenever possible to separate the participant and 
experimenter. MRI scans will be completed using HRRC approved protocols for 
scanning during the SARS-CoV-2 pandemic. 
 
 
Table 1. Assessments 
Order 
Measure 
Time (max 
minutes) 
1 
Consent + MRI Screen + Demographics 
30 
2 
Rivermead Post Head Injury Questionnaire 
10 
3 
Apathy Evaluation Scale (AES) 
5 
4 
Apathy Motivation Index (AMI) 
5 
5 
Neurobehavioral Symptom Inventory 
5 
6 
NIH-Toolbox Cognition Battery 
45 
7 
Frontal Systems Behavior Scale 
10 
8 
Barratt Impulsivity Scale 
5 
9 
Padua Inventory-Revised 
5 
10 
Meta-Cognitions Questionnaire 
5 

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11 
Toronto Alexithymia Scale 
5 
12 
The Next Big Five Inventory 
5 
13 
Beck Anxiety Inventory 
5 
14 
Beck Depression Inventory 
5 
15 
Posttraumatic Stress Disorder checklist 
5 
16 
Substance & Alcohol Use Questionnaires 
10 
17 
Practice of fMRI Task (‘Bandit Task’) 
5 
18 
Practice of fMRI Task #2 (‘Apples Task’) 
5 
ALL 
Total 
170 
minutes 
 
 
• Demographics: The Demographics spreadsheet includes background 
information on ethnicity, education, alcohol, and medications. It is attached in 
Appendix 10. 
 
• Rivermead Post Head Injury Questionnaire: Is a semi-structured, gold 
standard interview used to assess each participants’ TBI history in depth. This 
is primarily to provide evidence that HC participants in this study have 
quantifiably fewer / less severe TBI histories than patients in Study #19-053. 
It is attached in Appendix 11. 
 
• Apathy Evaluation Scale (AES): Is an 18-item self-report measure used to 
assess apathy symptoms in individuals with neurological disorders such as 
TBI. It is attached in Appendix 12. 
 
• Apathy Motivation Index (AMI): Is an 18-item self-report measure used to 
assess apathy symptoms in individuals with neurological disorders similar to 
the AES, but also assays a dimension known as “social-motivational apathy”. 
It is attached in Appendix 13. 
 
• Neurobehavioral Symptom Inventory (NSI): The NSI is a 22-item self- 
report questionnaire designed to probe the specific set of sequelae experienced 
by patients with TBI. Patients rate the degree to which they have experienced 
a set of common symptoms on a scale of 0-4, depending on how severely they 
have disturbed the patient in the past two weeks. It is attached in Appendix 
14. 
 
• NIH-Toolbox Cognition Battery (NIH-TB): The NIH-TB is a 
comprehensive set of standardized cognitive assessments developed by the 
NIH to evaluate a range of cognitive functions–including attention, episodic 
memory, executive function, language, processing speed, and working 

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memory20. These tasks will be administered on an iPad, with a member of the 
research team supervising the participants’ progress and answering any 
questions they might have. The NIH-TB is not a pen and paper task, and was 
not programmed by the PI, and is therefore not appended here. However, for 
reference the NIH has posted a series of demonstration videos on YouTube: 
https://www.youtube.com/channel/UC-WnVlfVYm5i5xULhBCjOkQ 
 
• Frontal Systems Behavior Scale (FrSBe): Is a self- or family-report 
questionnaire comprising 46 items that are highly sensitive to behavioral 
syndromes that present in patients with frontal brain injury. In particular, the 
FrSBe provides measures of apathy, disinhibition, and executive dysfunction. 
We will be using the self-report version in the current protocol. 
 
• Barratt Impulsivity Scale (BIS): The BIS is a 30-item self-report 
questionnaire that is designed to measure several dimensions of impulsivity. 
Items are rated in terms of frequency (from 1=rarely/never to 4=almost 
always/always). Principal component analyses of the items on the BIS has 
suggested that it is comprised of three distinct factors: motor impulsivity (e.g. 
“I am restless at the theatre or lectures”), non-planning impulsivity (e.g. “I buy 
things on impulse”), and attentional impulsivity (e.g. “I am self-controlled”)25. 
The BIS provides a dimensional measure of each of these factors that is useful 
for capturing levels of impulsivity in both the subclinical and clinical range. 
All BIS items are attached in Appendix 15. 
• Padua Inventory-Revised (PI-R): The PI-R is a 39-item self-report 
instrument that is ideally suited for measuring OC traits in the subclinical and 
clinical range26. Similar to the BOCS, the PI-R breaks down into five factors, 
including contamination obsessions (e.g. “I feel my hands are dirty when I 
touch money”), dressing/grooming compulsions (e.g. “I feel obliged to follow 
a particular order in dressing, undressing, and washing myself”), checking 
compulsions (e.g. “I have to do things several times before I think they are 
properly done”), obsession thoughts of harm to self/others (e.g. “I imagine 
catastrophic consequences as a result of absent-mindedness or minor errors 
which I make”), and obsessional impulses to harm self/others (e.g. “When I 
look down from a bridge or a very high window, I feel an impulse to throw 
myself into space”). Items are rated with respect to intensity, from 1 = “not at 
all” to 5 = “very much”. Scoring details and the items from the PI-R are 
attached in Appendix 16. 
 
• Meta Cognitions Questionnaire (MCQ): The MCQ a 30-item self- report 
instrument that is designed to measure one’s beliefs about their degree of 
access to and control over worry and intrusive thoughts27. Anosognosia–i.e. 
reduced awareness of one’s own psychopathology– is often occurs in TBI, it 
will be critical to evaluate patients’ degree of conscious access to their mental 
states through the MCQ. The MCQ can be broken down into positive beliefs 

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(e.g. “worrying helps me avoid problems in the future”), negative beliefs (e.g. 
“my worrying is dangerous for me”), cognitive confidence (e.g. “I have little 
confidence in my memory for words or names”), need for control (e.g. “I 
should be in control of my thoughts at all times”), and cognitive self- 
consciousness (e.g. “I think a lot about my thoughts”). The MCQ-30 is 
attached in Appendix 17. 
 
• Toronto Alexithymia Scale (TAS): The TAS is a self-report questionnaire 
designed to assess one’s ability to identify and describe their own emotions28. 
Participants rate 20 items on a 5-point Likert with respect to agreement (I.e. 1- 
Strongly Agree to 5- Strongly Disagree). TAS data reliably loads onto three 
factors: difficulty identifying feelings (e.g. “I am often confused about which 
emotion I am feeling”), difficulty describing feelings (e.g. “It is difficult for 
me to find the right words for my feelings”), and externally-oriented thinking 
(e.g. “I prefer to analyze problems rather than just describe them”). The TAS 
is attached in Appendix 18. 
 
• The Next Big Five Inventory (BFI-2): This is a recent revision of the classic 
big five personality inventory29, in which participants rate 60 items related to 
their personality with respect to their level of agreement (1 = disagree strongly 
to 5 = agree strongly). The BFI-2, like the original BFI, is designed to classify 
participants based on their personality in five dimensions: openness, 
conscientiousness, extraversion, agreeableness, and neuroticism. The BIF-2 is 
attached in Appendix 19. 
 
• Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report 
questionnaire of a variety of somatic (e.g. “hot/cold sweats”) and affective 
(e.g. “fear of worst happening”) anxious manifestations. Ratings are with 
respect to frequency of symptoms over the past month, ranging from 0 = “not 
at all” to 3 = “severely”30. The BAI is attached in Appendix 20. 
 
• Beck Depression Inventory (BDI): The BDI is a 21-item self-report 
questionnaire of a variety of symptoms of depression, such as boredom (“I am 
dissatisfied or bored with everything”) and rumination about the future (“I feel 
the future is hopeless and that things cannot improve”)31. The BDI is attached 
in Appendix 21. 
 
• Posttraumatic Stress Disorder Checklist, DSM 5 (PCL-5): The PCL5 is a 
20-item self-report inventory of PTSD symptoms (e.g. “disturbing memories 
of experience,” “feeling distant or cut off from other people,” etc.), which are 
rated based on how frequently the participant has experienced those symptoms 
in the past month32. The PCL-5 is attached in Appendix 22. 

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• Substance Use Questionnaire (SUQ): The SUQ is a brief self-report 
inventory dealing with the consumption of alcohol, and both legal and illegal 
drugs. The SUQ is attached in Appendix 23. 
 
• Alcohol Use Disorder Identification Test (AUDIT): the AUDIT is a gold 
standard self-report assay dealing more specifically with the consumption of 
alcohol and is attached in Appendix 24. 
 
• Bandit Task: The Bandit task is the gold standard for isolating the neural 
circuits underlying explore/exploit decision making in humans and nonhuman 
primates24–27,55. During this task, participants select between images with 
varying probabilities of receiving a reward. After learning the reward values 
of each picture over a series of trials, at random intervals one of the pictures is 
swapped for a novel picture with a randomly assigned reward value that may 
be higher or lower than the remaining familiar pictures. This process is 
repeated for a series of trials, and participants are told that if they score high 
enough on a randomly selected trial, they will earn a bonus $20. In actuality, 
the $20 will be awarded to all participants as part of the standard 
compensation rate at the end of the experiment. Therefore, this process will 
motivate participants to accumulate points on the task, but will be evenly 
compensated no matter how they do on the task. A random set of pictures will 
be randomly selected from the International Affective Picture System 
(IAPS56) for each participant. The task was programmed by the PI, and a 
sample trial image is provided in Appendix 25. A brief practice version of the 
Bandit task will be performed with a research team member prior to the MRI 
portion on day 1, 2 or 3 of the protocol (≈3 minutes). 
 
• Apples Task: The Apples task is an effort-based decision-making task that 
will be performed during MRI data collection on all days of the protocol. 
Participants will begin by practicing effortful grips requiring a certain 
percentage of their maximum voluntary contraction on a dynamometer 
(%MVC; Appendix 26). After experiencing the effort required to execute 
various %MVC grips, participants will be asked to make a series of reward- 
effort tradeoff decisions (Appendix 26). Each trial will randomly sample the 
parameter space between 20 and 100%MVC and one to thirteen apples. 
Participants will be told that at the end of the session the experimenter will 
select a random set of 10 responses they said ‘yes’ to during the MRI, but in 
reality (similar to the Bandit task) all subjects will receive a $20 bonus for 
completing the task. This will ensure participants are motivated, without 
placing a burden on them in terms of their physical effort requirement. A brief 
practice version of the task will be performed with a research team member 
prior to the MRI portion on day 1 of the protocol (≈5 minutes). 
 
• TMS Protocol: On day 2 and 3 of the protocol, single pulses of TMS will 
be applied over the scalp area overlying the participants’ motor cortex 
using a 

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handheld TMS coil (Magventure MagPro; Magventure, Inc., Alpharetta, 
Georgia, USA). TMS pulses will be delivered through an air-cooled coil in 
either a figure-eight or double-cone shape, with the latter being particularly 
useful for targeting deeper structures such as dACC. The first phase of the 
TMS protocol will involve a standardized motor-thresholding procedure, 
wherein peripheral responses evoked by single TMS pulses are recorded via 
an electromyographic recording device (BioPac psychophysiological 
recording system; BIOPAC Systems, Inc., Goleta, CA). In this phase, the 
TMS coil’s stimulation intensity is titrated to a level that is comfortable yet 
effective at reliably exciting neuronal populations orthogonal to the coil (50% 
MEPs ≥50µv; typical duration≈20-40 mins). Then, the repetitive TMS (rTMS) 
procedure will be administered to a pre-determined cortical target based on the 
individual’s pre-TMS fMRI scan using a Localite Neuronavigation system 
(TMS Navigator, Localite GmbH, Bonn, Germany; duration≈10-20 mins). 
The rTMS protocol will involve the delivery of a train of TMS pulses over a 
cortical target prior to performance of the behavioral tasks during a post-rTMS 
fMRI scan. 
 
o Our rTMS protocol will involve one of two safe and widely used ‘theta-burst’ 
stimulation procedures, which are used to drastically reduce the total amount 
of time required for rTMS pulse delivery (Huang et al., 2005, Neuron). Theta 
burst rTMS will take the form of either intermittent theta burst stimulation (up 
to 1200 pulses delivered in 50Hz triplets for 2s every 10s with an 8s gap, 
resulting in a total stimulation duration of 190s) 73 or continuous theta burst 
stimulation (up to 3600 pulses delivered in 50Hz triplets continuously for 40s) 
73. Intermitted theta burst enhances cortical excitability at the target site, 
whereas continuous theta burst stimulation inhibits cortical excitability. 
However, prior studies have observed conflicting beneficial cognitive effects 
of both excitatory (e.g. Wang et al., 2014, Science) and inhibitory (e.g. 
Tambini et al., 2018, J Cogn Neurosci). Therefore, we will evaluate the 
behavioral and neural connectivity data after N=10 subjects using an 
intermittent theta-burst rTMS protocol, and if the effects are not trending in 
the hypothesized direction we will plan to reevaluate and potential shift to a 
continuous theta burst protocol. 
 
o Sham rTMS procedures will be identical, but will involve the delivery of 
subtle electrical stimulation underneath the TMS coil to mimic the tactile 
effects of rTMS without delivery of verum neuromagnetic stimulation. Both 
single pulse TMS / motor thresholding and rTMS are extremely safe when 
used within the safety guidelines for TMS. As an additional precaution, 
participants will be screened for contraindications to TMS using a gold- 
standard questionnaire71 (Appendix 4). 
 
• MRI Scan Protocol: Participants will complete two MRI sessions. Both scan 
sessions will take 1-2 hours and will happen on three separate days. To 
ensure 

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that there is no metal in their clothing, participants will be asked to remove 
their masks and change into a clean hospital shirt and pants before entering the 
MRI room. Participants will be given an MRI-compatible surgical face mask 
provided by MRN to wear during MRI scanning. Participants will perform 4 
functional task MRI runs of the Bandit task and the Apples task, which will 
take approximately 50 minutes total. Additionally, T1-weighted sequence (≈5 
minutes), a diffusion-weighted scan (dMRI; ≈12 minutes), and participants 
will look at a fixation cross for ≈11 minutes to collect resting state data. 
Resting state and task MRI runs will be repeated on the second and third 
sessions post- rTMS delivery, to elucidate the effectiveness of rTMS for 
engaging the targeted neuronal mechanisms. All task orders will be 
counterbalanced. 
 
13. Data Analysis 
13.1. Describe the data analysis plan, including any statistical procedures. 
All data will undergo standard preprocessing (e.g. motion correction, spatial 
normalization) and quality control prior to statistical modeling. Depending on the 
specific question of the study, data may be analyzed using the general linear 
model, independent components analysis, machine learning techniques, or a 
variety of other standard approaches for neuroimaging data. 
13.2. Provide a power analysis 
Prior studies using fMRI-guided TMS to modulate task-related neural 
computations have observed effect sizes of approximately d≈1.0267-69, requiring a 
sample of N=17 per group. 
14. Provisions to Monitor the Data to Ensure the Safety of Subjects 
The protocol is minimal risk. As this study fits NIH criteria for a clinical trial– 
with subjects prospectively assigned to an intervention–an independent Data 
Safety and Monitoring Board (DSMB) will review the study data on an annual 
basis with the PI to ensure participant safety (annual reports to the DSMB– 
Appendix 28). The DSMB for this study will be composed of Drs. Christopher 
Abbott (UNM Psychiatry) and Dr. Vincent Clark (UNM Psychology). Their 
experience in assuring safety of brain stimulation therapies and seizure 
monitoring protocols make them ideally suited to serving on this project’s DSMB. 
Continuous, close monitoring of participant safety will include prompt and 
frequent reporting of safety data (i.e., adverse/serious adverse events) to the 
DMSB and the University of New Mexico Health Sciences Center Human 
Research Protections Office. The PI and members of the DSMB are well-versed 
in the latest scientific literature on noninvasive brain stimulation, and in each 
meeting will allocate time to discuss any new studies that might inform the safety 
or conduct of this study. According to best estimates, the rate of adverse/serious 
adverse events using rTMS safely is approximately 0.1% (Dobek et al., 2015, 
Neuropsychiatr Dis Treat.). Therefore, if a single seizure is reported in the current 
study, the DSMB will carefully evaluate whether some risk factors were missed 

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during the consent and TMS contraindications screening (namely: sleep 
deprivation, a personal or family history of seizures, or neurological disorders 
such as moderate-to-severe traumatic brain injury, multiple sclerosis, or stroke). If 
we observe a seizure where no such prior indicators are identified by the DSMB, 
the study will be suspended while we revise our rTMS protocol, and consider 
alternative stimulation parameters (e.g. lower rTMS dose), or targets (e.g. other 
nodes of the brain’s value and effort computation circuits). 
15. Withdrawal of Subjects 
Participants may withdraw from the study at any time without penalty. To protect 
the integrity of the research study, data collected up to the time of subject 
withdrawal will remain in the database and managed according to the protocols 
outlined in Section 16. Alternatively, subjects may submit written notification that 
they intend to withdraw their authorization for their data to be used in the current 
study, which is described to participants in the detailed consent statement. 
 
16. Data Management/Confidentiality 
• All data are coded with a unique research subject identifier (URSI) number. 
Electronic data is stored on password protected computers only accessible by 
the research team, and on the COINS database on a secure HIPAA compliant 
cloud-based server. For non-computer based forms, the data collection sheets 
are stored in a locked cabinet in a locked office. 
• Paperwork with identifying information–namely, payment receipts and study 
consent forms–will be stored in a locked filing cabinet in the CBRR while the 
study is being conducted, and retained there for long-term storage after data 
collection is complete. The laboratory’s door will be kept locked, and located 
within the Psychology Clinical Neurosciences Center (PCNC) on the second 
floor of Logan Hall, which is only accessible to approved PCNC staff. These 
forms will be maintained for a maximum of 7 years after which they will be 
shredded by a member of the research team. 
• Additionally, the CBRR maintains a repository of documents on REDCap 
(Research Electronic Data Capture)72 to trace subjects and their documents for 
use during audits, or for the potential future benefit of the participant. The 
Research Supervisor and two research staff will have access to this repository. 
MRN also retains the link between identifiers and URSI indefinitely for the 
potential future benefit to the research participant. For example, it may 
become medically advantageous in the future for a former participant to have 
access to the clinical information that is present in most radiological scans. 
For example, if a participant is diagnosed with a neurological condition (e.g. 
multiple sclerosis, glioblastoma, TBI, etc.) it may be clinically beneficial for 
the participant’s physician to have access to a research scan that was 
performed at an earlier time-point to determine disease course and severity. 
Both the Phone Screen spreadsheet and Master Key spreadsheet are password 

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protected and only accessed by the Research Coordinator as per UNM North 
Campus IRB suggestions. 
• All assessments will be administered electronically and tracked using the 
participant’s URSI number, and no personally identifiable information. During 
data collection and analysis, all electronic data will be stored on COINS, on 
servers at the Center for Advanced Research Computing (CARC) for 
advanced fMRI data processing pipelines, and accessed using secured 
computers in either the PI’s office or laboratory at Logan Hall on main 
campus. The data will be archived via local backups to secured servers 
maintained by PCNC staff. 
• 
In order to further protect the confidentiality of participant data, 
NIH-funded projects automatically fall under a Certificate of 
Confidentiality (CoC). With this certificate, the investigators cannot be 
forced (for example, by court subpoena) to disclose research 
information that may identify the participant in any Federal, State, or 
local civil, criminal, administrative, legislative, or other proceedings. 
Disclosure will be necessary, however, upon request of DHHS or other 
federal agencies for audit or program evaluation purposes. The CoC 
will not prevent the participant or a member of the participant’s family 
from voluntarily releasing information about themselves or their 
involvement in this research. Note however, that if an insurer or 
employer learns about the participant’s participation, and obtains 
consent to receive research information, then the investigator may not 
use the CoC to withhold this information. This means that the 
participant and the participant’s family must also actively protect their 
own privacy and the confidentiality of their data. Finally, the 
investigator is not prevented from taking steps, including reporting to 
authorities, to prevent serious harm of the participant or others. 
 
17. Data and Specimen Banking 
To promote open and rigorous science practices, de-identified behavioral data and 
skull-stripped MRI data (i.e. with any potentially identifiable facial features removed 
from the brain images) will be hosted for use by external researchers through the 
COINS Data Exchange System. The data storage and sharing plan is described in the 
informed consent statement. 
Additionally, Participants will be given the option of having their data stored in the 
MRN Data Repository (see HRRC# 06-387, PI: Roberts). 
18. Risks to Subjects 
• Contrast-free MRI has not been associated with any known adverse effects 
and is considered minimal risk by the FDA and OHRP. 

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• Since the scanner is a powerful magnet, it is possible to move objects 
containing ferrous metal in the room during the scan. Accordingly, as per 
MRN policy, all participants will wear MRI-compatible scrubs for the scan, 
and will complete a safety screening form to reveal any contraindications to 
MRI (Appendix 3) prior to completing study protocols. 
• On rare occasions, some participants may experience discomfort due to 
claustrophobia when inside the MRI scanner. For such events, an emergency 
squeeze ball will be provided to participants. This ball elicits an alarm in the 
MRI control room, which will enable the MRI technologist/research team to 
rapidly extricate participants from the scanner if needed. 
• The scanner produces loud ‘drum’ beating noises that are slightly different 
across the different scanning protocols. During the consent process, each of 
these different scanner noises will be played for the participant via 
headphones, to ensure they are familiar with these sounds prior to entering the 
scanner environment. Additionally, noise attenuating headphones will be 
provided for ear protection during the MRI protocols. 
• On rare occasions, large or recent tattoos can heat up during an MRI scan and 
cause skin irritation like a sunburn. All recent tattoos will be cleared with the 
MRI technician before scan sessions to reduce burn risk. 
• The current protocol will follow HRRC-approved MRN MRI policy for 
pregnancy testing adult females (page 2 of Appendix 26). Specifically, all 
females who have had their first menstrual period must answer “no” to the 
question on the safety screening form that asks if there is any possibility of 
being pregnant. If there is any uncertainty, or if the participant requests to take 
a pregnancy test, a urine pregnancy test will be administered and documented 
as negative prior to MR imaging. Testing is the responsibility of the PI and/or 
their designated research team members. All results are confidential and are 
discussed with the participant alone (regardless of participant age) in 
compliance with applicable laws and regulations. In the event of an 
unexpected positive pregnancy test, participant partners, family members, and 
parents may be told that the participant is not eligible for MR scanning, but no 
further explanation is given unless requested by the participant. 
• 
Due to the very high sensitivity of MRI in detecting abnormalities, there is a 
risk of false-positive findings. This may result in anxiety and additional 
testing, possibly including a recommendation for clinical scans at your cost. 
The radiology report or other study data will not be put into participant 
medical record unless they provide it to their physician. If the radiology report 
becomes part of their personal medical record, it may or may not have an 
effect on their getting health insurance or life insurance in the future. 
 
• TMS is considered a minimal risk procedure but can produce side effects that 
are noted here. Most people do not find TMS painful but occasionally strong 

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contractions of the scalp muscles can cause discomfort or headache that 
usually go away promptly with nonprescription medication. The noise of the 
TMS magnet may affect hearing, so participants will be fitted with earplugs. 
Like MRI, TMS involves the use of a powerful magnet. Thus TMS will not be 
performed on people who have pacemakers, implanted pumps or stimulators, 
or who have metal objects inside their heads. The risk of inducing seizure with 
rTMS is considered very low at <0.1%. However, certain factors increase the 
risk of seizure such as sleep deprivation, family history of seizures, 
polypharmacy, alcohol use, and previous neurological conditions. Participants 
will be carefully screened for these factors to ensure that risk of seizure is 
minimized (Appendix 4). 
• The CBRR and MRN are both located on the UNM North Campus, in close 
proximity to the UNM-ER. Therefore, participants will have rapid access to an 
emergency facility should an unforeseen medical emergency occur during 
testing. 
• Participants will be told that they will only win a $20 merchandise card on the 
primary task of interest (Bandit task) if they perform it well. However, at the 
end of the task all participants will receive the same compensation regardless 
of task performance. This protocol is used to ensure high motivation to 
perform the Bandit task, but may lead some participants to feel deceived at the 
end of the study. Accordingly, the reason for this procedure–i.e. “to ensure 
participants are motivated to try their best on the Bandit task”–will be 
explained clearly during a debrief at the end of the experimental session. 
 
• During the SARS-CoV-2 pandemic, the current study’s procedures will be in 
accordance with the guidelines provided by the State of New Mexico and 
UNM-HSC Office of Research for maintaining physical distancing and face 
coverage. While supporting the efforts to reduce the spread and risk of 
infection, COVID-19 exposure is a potential risk associated with this study. 
 
19. Potential Benefits to Subjects 
• Participants will help science and medicine better understand how TBI 
impacts the brain and decision-making and may help to better diagnose 
psychiatric problems in TBI patients using brain imaging. 
20. Recruitment Methods 
HC participants from the community will have been recruited via a flier that 
will be posted in public buildings, local businesses, and through other 
advertisement mechanisms such as the Weekly Alibi local newspaper, 
Craigslist, etc. From the participants’ perspective, all study advertisements 
will appear as either the study flier (Appendix 5), or one of the approved 
online advertisements (Appendices 6-7). Electronic links to the study flier 
will appear as an approved link phrase (Appendix 29) and the approved 
thumbnail (Appendix 30). In certain instances, targeted advertisement 
through social media platforms (Facebook, Instagram, or Twitter) may be 

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used to ensure a demographic match  between the current study and linked 
clinical study 19-053. In particular, if the current sample and 19-053 are 
unmatched with respect to age or sex, we will use widely-available 
advertisement filtering algorithms on these platforms to ensure that 
individuals from particular age or sex groups in the local Albuquerque 
community are more likely to see our approved recruitment materials. This 
step will be critical from a scientific perspective, ensuring our final sample 
will enable a valid comparison between our key outcome measures between 
the current study and 19-053. HC participants who consented to be contacted 
for future studies within the COINS system may also be contacted within the 
current protocol. 
21. Provisions to Protect the Privacy Interests of Subjects 
• 
Participants will be assigned a unique research subject identifier (URSI) 
number prior to their arrival on the day of their study participation, which 
will link their data with their name and other identifying information in the 
COINS system. After data collection is complete, the linking code will be 
made inaccessible to the research team. 
• 
Participant behavioral testing rooms at the CBRR are equipped with white 
noise generators to ensure privacy during testing. 
• 
The MRN has private changing rooms including lockers for participants to 
store their personal items during the MRI portion of the protocol. 
22. Economic Burden to Subjects 
Participants will not be charged for any of the experimental study procedures, 
including MRI scans and TMS sessions. If incidental findings from the study result in 
the need for further evaluation/treatment, the participant or their insurance company 
will be responsible for additional clinical evaluation/treatment that may be needed. 
Also, incidental finding information is disclosed only to the individual participant. 
However, if a participant chooses to disclose such information also to their personal 
physician, this may become part of their medical record which may or may not have 
an effect in the future on getting health or life insurance. 
23. Compensation 
Participants will be paid $30/hour cards for participation in the current study via 
Greenphire cash cards that can cashed out at any bank or physical/online store. 
This rate is in line with standard UNM compensation rates, particularly for patient 
studies where recruitment can be difficult. Minimum compensation will be $30, 
and after the first hour compensation will be rounded up to the nearest half hour 
for participants who do not complete the protocol. Participants will also receive 
$20 for completion of the Bandit Task (explained on page 12). 
24. Compensation for Research-Related Injury 
No commitment is made by UNM, UNM-HSC, or MRN to provide free medical 
care or money for injuries to participants in this study. This is clearly stated in the 
consent form. 
25. Consent Process 

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• 
Phone screening: The protocol will be described in detail during the phone 
screening only for participants who meet the study inclusion / exclusion 
criteria. We request a waiver of consent for the phone screen process. If the 
participant is unable to communicate effectively, a video call will be made to 
accommodate them. 

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• 
Phone Consent Process: Due to the SARS-CoV-2 pandemic and in 
consideration of the safety and health of both participants and staff, the 
consent process will be completed via a HIPAA compliant Zoom account or 
phone call. All documents will be sent and completed through email or fax 
depending on participant preference. Participants unable to provide informed 
consent independently will be excluded in the current protocol, therefore the 
consent process will not require a legally authorized representative. Prior to 
the initiation of the protocols, participants will be given sufficient time to 
consider participation. The study MRI safety screening form and the 
informed consent statement are attached. Participants will be given time to 
complete a physical copy of the MRI safety screening form, to confirm their 
responses to the same items that were covered verbally with a member of the 
research team during the phone screen. Participants will be given time to go 
through the informed consent statement, and an IRB-approved member of the 
research team will verbally describe the most important points of the consent 
statement prior to beginning the protocol via Zoom or phone call. For 
participants who indicate that they have been diagnosed with a learning 
disability including dyslexia, the consent form will be read to participants by 
a member of the study team. Specifically, the team member will clarify what 
will happen over the course of the protocol, the minimal potential side effects 
of the protocol, and the fact that the primary benefit for participating in the 
proposed research will be financial remuneration and an MRI reading by a 
radiologist. Most importantly, participants will be told that their completion 
of the protocols is entirely voluntary, and that they can discontinue their 
participation at any time. After each point, the team member will ask for 
verbal consent from the candidate participant. All participants are required to 
be fluent in English. All participants are required to be cognitively capable of 
providing their informed consent to complete the protocol. HIPAA 
authorization is included in the consent form and will be obtained for all 
participants. 
 
• 
Note: For the duration of the SARS-CoV-2 pandemic, participants will be 
asked screening Question #34 (Appendix 1) during both the phone screen 
and at the end of the remote consenting procedure. Any “yes” response to this 
question during screening or consenting will result in exclusion from the 
study at this time, with the possibility to re-screen / re-consent for the study 
after provision of a negative COVID-19 test result and a cessation of 
associated symptoms for ≥14 days. 
 
 
26. Documentation of Consent 
Signatures will be obtained as documentation of informed consent for all 
participants. 

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27. Study Test Results/Incidental Findings 
• 
MRI Reading: All research MRI scans are read for incidental findings by a 
radiologist. When the scan is read, an e-mail notification is sent to the 
participant letting them know new results are available. The participant can 
securely log in to the COINS Homepage to access their MRI radiology report. 
No sensitive or identifying information is sent via e-mail. If an abnormality 
that requires follow-up is identified, such as a Doctor Referral 
recommendation, a hard copy of the report may be mailed to the participant in 
addition to the e-mail notification. In these cases, the MRN Medical Director 
may also attempt to contact the participant by phone to explain the 
information and help answer questions. 
28. Sharing Study Progress or Results with Subjects 
N/A – Study progress or results will not be shared with participants for this 
protocol. 
29. Inclusion of Vulnerable Populations 
N/A – This protocol does not involve selective recruiting any vulnerable 
populations. 
30. Community-Based Participatory Research 
N/A – This protocol does not involve community-based participatory research. 
31. Research Involving American Indian/Native Populations 
N/A – This protocol does not involve selective recruiting of Indian/Native 
populations. 
32. Transnational Research 
N/A – This is a protocol for a single-site study. 
33. Drugs or Devices 
• The following devices will be used in the study: a Magventure MagPro X100 
(Magventure, Inc., Alpharette, Georgia, USA). This TMS device is FDA 
approved for the treatment of treatment-resistant depression. The TMS device 
used in this study is determined to be a Non-Significant Risk device by the 
Principal Investigator (Jeremy Hogeveen, PhD). The device is housed at UNM 
in the Noninvasive Neurostimulation Lab, and access will be limited to study 
personnel who are trained to use this device safely. 

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Checklist Section 
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB. Please complete all checklists relevant to your research. 
 
 
I. Waivers or Alterations of Consent, Assent, and HIPAA Authorization 
 
A. Partial Waiver of Consent for Screening/Recruitment 
Complete this checklist if you are requesting a partial waiver of consent so that you 
can review private information to identify potential subjects and/or determine 
eligibility prior to approaching potential subjects for consent or parental permission. 
 
1. Describe the data source that you need to review (e.g., medical records): N/A 
2. Describe the purpose for the review (e.g., screening): N/A 
3. Describe who will conducting the reviews (e.g., investigators, research staff): 
N/A 
4. Do all persons who will be conducting the reviews already have permitted 
access to the data source? 
Yes 
No. Explain: 
 
5. Verify that each of the following are true or provide an alternate justification 
for the underlined regulatory criteria: 
a) The activity involves no more than minimal risk to the subjects 
because the records review itself is non-invasive and the results of the 
records review will not be used for any purposes other than those 
described above. 
True 
Other justification: 
 
b) The waiver or alteration will not adversely affect the rights and 
welfare of the subjects because eligible subjects will be approached for 
consent to participate in the research and are free to decline. Further, 
the information accessed during the records review will not be 
 
disclosed to anyone without a legitimate purpose (e.g., verification of 
eligibility). 
True 
Other justification: 

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c) The research could not practicably be carried out without the waiver or 
alteration because there is no other reasonably efficient and effective 
way to identify who to approach for possible participation in the 
research. 
True 
Other justification: 
 
d) Whenever appropriate, potentially eligible subjects will be presented 
with information about the research and asked to consider 
participation. (Regulatory criteria: Whenever appropriate, the 
subjects will be provided with additional pertinent information after 
participation.) 
True 
Other justification: 
 
Partial Waiver of HIPAA Authorization for Screening/Recruitment 
Complete the following additional questions/attestations if the records you will 
review to identify potential subjects and/or determine eligibility include Protected 
Health Information (PHI). 
The protected health information will not be reused or disclosed to any other person 
or entity, except as required by law, for authorized oversight of the research study, or 
for other research for which the use or disclosure of protected health information for 
which an opportunity to agree or object is not required by 45 CFR 164.512 
 
6. Will you be recording any PHI when conducting the records review to identify 
potential subjects and/or determine eligibility? 
Yes. Describe: 
No 
 
7. If you answered “Yes” to question 6 above, please describe when you will 
destroy identifiers (must be the earliest opportunity consistent with the 
conduct of the research) or provide justification for why they must be 
retained: N/A 
8. The PHI accessed or recorded for identification/screening purposes will not be 
reused or disclosed to (shared with) any other person or entity, except as 
required by law, for authorized oversight of the research study, or for other 
research for which the use or disclosure of the PHI would be permitted under 
the Privacy Rule. 
True 
False 

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B. Waiver of Documentation of Consent 
Complete this checklist if you intend to obtain consent verbally but will not be 
obtaining signatures from subjects on a consent form to document consent. Waivers 
of documentation of consent are commonly requested when using scripts, information 
sheets, or email or survey introductions to present the elements of consent instead of 
using a traditional consent form. 
 
1. Are you requesting a waiver of documentation of consent for some or all 
subjects? 
All 
Some. Explain: 
 
2. Provide justification for one of the following: 
a) That the only record linking the subject and the research would be the 
consent document and the principal risk would be potential harm 
resulting from a breach of confidentiality. Each subject will be asked 
whether the subject wants documentation linking the subject with the 
research, and the subject's wishes will govern. 
N/A 
b) That the research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written consent is 
normally required outside of the research context. 
N/A 
3. Do you intend to provide subjects with a written statement regarding the 
research in lieu of a traditional consent form? 
Yes. Please attach a copy to your submission in Click. 
No 
 
 
 
 
 
 
 
 
References 

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1. Padoa-Schioppa, C. Neurobiology of economic choice: A good-based model. Annual 
Review of Neuroscience 34, 333–359 (2011). 
2. Rangel, A. & Clithero, J. A. The Computation of Stimulus Values in Simple Choice. in 
(eds. Glimcher, P. & Fehr, E.) 125–147 (Academic Press, 2014). 
3. Averbeck, B. B. & Costa, V. D. Motivational neural circuits underlying reinforcement 
learning. Nature Neuroscience 20, 505–512 (2017). 
4. Li, J., Delgado, M. R. & Phelps, E. A. How instructed knowledge modulates the neural 
systems of reward learning. Proceedings of the National Academy of Sciences 108, 55– 
60 (2011). 
5. Walton, M. E., Bannerman, D. M., Alterescu, K. & Rushworth, M. F. S. Functional 
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