Manipulating the Reward Circuit With TMS
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Sponsor: Florida State University

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INSTRUCTIONS:

Use “TEMPLATE PROTOCOL (HRP-503)” to prepare a 
document with the information from following sections. 

Depending on the nature of your study, some sections may not be 
applicable to your research. If so mark as “NA”. For example, 
research involving a retrospective chart review may have many 
sections with “NA.”  For subsections, like 1.x or 8.x, you can 
delete it if it’s not applicable.

When you write a protocol, keep an electronic copy. You will need 
to modify this copy when making changes.

As you are writing the protocol, remove all instructions in italics 
so that they are not contained in the final version of your protocol.

Omit starred (*) items if this is the activation of a protocol at a 
new site or sites that will be overseen by a principal investigator 
who will take separate and full responsibility for that site or those 
sites. Complete by describing information specific to the site(s). Do 
not repeat information in the approved protocol that applies to all 
site(s).
PROTOCOL TITLE:
Studying Reward Processing with fMRI, EEG, and TMS 
PRINCIPAL INVESTIGATOR:
Derek Evan Nee 
Psychology 
850-644-1963 
nee@psy.fsu.edu
VERSION NUMBER/DATE:
Include the version number and date of this protocol.
REVISION HISTORY
Revision 
#
Version Date
Summary of Changes
Consent 
Change?
1
4/19/2022
Added self-report and interview measures, 
more detailed exclusion criteria. Added 
protocol for assessing and addressing risk for 
suicide, and training for basic life support. 
Yes
2
6/24/2022
Updated locations in which recruitment flyers 
can be posted and distributed. Additional self-
report survey (DASS-21). Changes are 
highlighted in red. 
No
3
8/12/22
Updated recruitment location to include 
ResearchMatch
No
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4
6/28/2024
Added recruitment site
No
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Table of Contents
1.0
Study Summary ........................................................................................................3
2.0
Objectives* ...............................................................................................................4
3.0
Background*.............................................................................................................4
4.0
Study Endpoints*......................................................................................................4
5.0
Study Intervention/Investigational Agent.................................................................4
6.0
Procedures Involved* ...............................................................................................5
7.0
Data and Specimen Banking*...................................................................................5
8.0
Sharing of Results with Subjects* ............................................................................6
9.0
Study Timelines*......................................................................................................6
10.0
Inclusion and Exclusion Criteria* ............................................................................6
11.0
Vulnerable Populations*...........................................................................................6
12.0
Local Number of Subjects ........................................................................................7
13.0
Recruitment Methods................................................................................................7
14.0
Withdrawal of Subjects*...........................................................................................7
15.0
Risks to Subjects*.....................................................................................................7
16.0
Potential Benefits to Subjects* .................................................................................8
17.0
Data Management* and Confidentiality...................................................................8
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*...........................8
19.0
Provisions to Protect the Privacy Interests of Subjects ............................................9
20.0
Compensation for Research-Related Injury..............................................................9
21.0
Economic Burden to Subjects...................................................................................9
22.0
Consent Process........................................................................................................9
23.0
Process to Document Consent in Writing...............................................................12
24.0
Setting.....................................................................................................................13
25.0
Resources Available ...............................................................................................13
26.0
Multi-Site Research* ..............................................................................................13
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1.0
Study Summary
Study Title
Studying Reward Processing with fMRI, EEG, and TMS
Study Design
Within-subject Experimental/Control Design
Primary Objective
The purpose of the proposed research is to examine the 
impact of TMS on brain activity that has been linked to 
anhedonia using functional magnetic resonance imaging 
(fMRI) and EEG.
Secondary 
Objective(s)
Research 
Intervention(s)/ 
Investigational 
Agent(s) 
NA
IND/IDE # 
Study Population
Adults, aged 18-55
Sample Size
80
Study Duration for 
individual 
participants
10-15 hours over 4-5 weeks
Study Specific 
Abbreviations/ 
Definitions 
fMRI – functional magnetic resonance imaging
EEG – Electroencephalogram
TMS – transcranial magnetic stimulation
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2.0
Objectives*
2.1
Describe the purpose, specific aims, or objectives.
The purpose of the proposed research is to further our understanding 
of neural activity that has been linked to anhedonia (i.e., reward-
related neural activity) – by examining the impact of multiple TMS 
sessions on reward-related neural activity.  Our goal is to assess 
whether stimulating medial prefrontal cortex, relative to the inion, 
produces increases in neural response to rewards using EEG and 
fMRI.  EEG, fMRI, and TMS are well-established, non-invasive 
techniques used by thousands of labs around the world to study brain 
function—and this work would begin to suggest specific ways to 
modulate neural activity that has been implicated in anhedonia and 
depression.
2.2
State the hypotheses to be tested.
We hypothesize that stimulating the medial prefrontal cortex 
(MPFC), relative to a control site (i.e., inion), using TMS (i.e., 5 
sessions over a week) will result in increases in reward-related EEG 
and fMRI measures.  We additionally examine whether TMS will 
result in changes in self-report measures.
3.0
Background*
3.1
Describe the relevant prior experience and gaps in current 
knowledge.
We have conducted extensive studies demonstrating hyperactive 
reward-related neural activity in depression and in relation to 
anhedonia.  In a recent study, we found that a single session of TMS 
to MPFC potentiated EEG-based reward measures.  In the current 
study, we extend this work to individuals who report high levels of 
anhedonia—and to multiple TMS sessions and include fMRI 
measures of reward-related neural activity as an outcome.  Finally, 
we assess whether TMS results in changes of self-report measures of 
anhedonia and related constructs.
3.2
Describe any relevant preliminary data.
We recently found that a single session of TMS to MPFC increased 
the RewP; that paper is currently under review and forms the basis 
for the current paper. We are interested in whether a more protracted 
TMS protocol to MPFC (5 sessions within a week) would increase 
reward-related neural measures relative to a control site – and if 
those changes might be longer lasting and relate to changes in self-
report.
3.3
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.
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We and others have found in multiple studies that depression is 
associated with reduced reward-related neural activity measured with 
fMRI and EEG.  Both are non-invasive tools that researchers have 
for studying human brain function, especially in the context of 
depression. Yet, there have been no causal demonstrations that 
increasing reward-related neural activity results in changes in 
depression or related experiences.  Here, we focus on anhedonia—
the degree to which individuals report day-to-day activities as 
enjoyable—as individual differences in anhedonia have consistently 
been linked to reward dysfunction.  
4.0
Study Endpoints*
4.1
Describe the primary and secondary study endpoints.
NA
4.2
Describe any primary or secondary safety endpoints.
NA
5.0
Study Intervention/Investigational Agent
1.1
Description: Describe the study intervention and/or investigational 
agent (e.g., drug, device) that is being evaluated.
NA
5.1
Drug/Device Handling: If the research involves drugs or device, 
describe your plans to store, handle, and administer those drugs or 
devices so that they will be used only on subjects and be used only by 
authorized investigators.
NA
5.2
If the drug is investigational (has an IND) or the device has an IDE 
or a claim of abbreviated IDE (non-significant risk device), include 
the following information:
NA
6.0
Procedures Involved*
6.1
Describe and explain the study design.
In the proposed research, we will use computer-based tasks that 
examine reward processing. Subjects will be screened by the MR 
technologist, and will be excluded if they meet any exclusion 
criteria. Subjects will be given instructions about the task and the 
MRI scanning environment. If there is any concern about 
claustrophobia, participants will be encouraged to try the mock 
scanner before entering the MRI scanner. The mock scanner is 
located next door to the MRI scanner and provides a simulated MRI 
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environment. If they are uncomfortable with the enclosed 
environment (at any time), they can exit the study and receive 
compensation for their time. Otherwise, participants will then be 
given a short practice session on the task either before entering the 
scanner, or during collection of preliminary and/or structural images. 
After being positioned in the scanner by the technologist, the 
technologist will acquire initial calibration scans. A structural image 
of the head and brain may be acquired before or after the functional 
imaging data. The remaining time in the scanner will be used to 
collect functional imaging data while subjects perform the task. 
Response time and accuracy data will be recorded during the task. 
We will relate these measures to the fMRI data from the scanner, in 
order to understand the relationships between neural activity and 
behavioral performance.
All TMS studies will conform to the safety limits established by 
Rossi et al., 2009 and recently updated by Rossi et al., 2021. Two 
types of offline designs may be used: A) Continuous Theta-Burst 
stimulation (TBS), which is one of the most widely used offline 
techniques in which 600 pulses are delivered in bursts of 3 pulses (at 
50 Hz) repeated at a rate of 5 Hz. This technique was introduced in 
2005 by Huang et al. and has been used in hundreds of studies since. 
B) Intermittent TBS, which is another widely used offline technique 
introduced by Huang et al., 2005. As in continuous theta burst 
stimulation, 600 pulses are delivered in 50 Hz bursts every 5 Hz.
However, in intermittent TBS, 2 seconds of stimulation is alternated 
with 8 seconds of no stimulation. Hence, the entire set of pulses is 
delivered over 190 seconds. Again, all procedures will conform to 
safety limits established by Rossi et al. 2009 and updated by Rossi et 
al., 2021. The versions of TBS that we administer have especially 
low rates of adverse effects (Oberman et al., 2011; Rossi et al., 
2021).
In order to dose appropriately the TMS stimulation, it is necessary to 
determine an individual’s sensitivity to TMS. This is done by 
delivering TMS to the motor cortex to affect muscle activity in the 
hand in order to record the motor threshold (MT). MT is the standard 
in the field for determining the intensity of TMS for each individual 
to ensure participant safety. MT will be determined in one of two 
ways: 1) Recording electromyography (EMG) of the first dorsal 
interosseus muscle of the hand contralateral to TMS to monitor 
muscle activity. In this case, persistent muscle activity will be 
elicited by having the participant activate the muscle using the 
appropriate flexion movement, and the effect of TMS on the muscle 
will be observed as a brief cessation of EMG activity. This is 
referred to as the active motor threshold (AMT). 2) Observing a 
visually-identified hand twitch in the hand contralateral to TMS (e.g. 
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if applying TMS to the left hemisphere of the brain, a twitch will be 
observed in the right hand). This is referred to as the resting motor 
threshold (RMT). In both cases, the scalp region producing the 
largest hand twitch will be identified. To identify this region, TMS 
will be set to 30% of the maximal stimulator output, which is well 
below the motor threshold for most, if not all, individuals. TMS will 
be delivered to a scalp location approximating the location of motor 
cortex based upon surface features using the nose and ears as 
landmarks. From this initial location, TMS will be delivered. If 
ineffective to produce a hand twitch, the TMS coil will be moved to 
a new, nearby site, which will subsequently be tested. This process 
will continue until a grid of locations has been tested around the 
starting location, approximating 5 cm2. If a hand twitch has not been 
produced, this indicates that the stimulation is below threshold and 
the stimulator output will be raised by 5% of the maximum 
stimulator output. The process will then repeat until the maximal 
hand twitch at a given stimulation level is observed, thereby 
indicating the location of interest. During this process, the participant 
will be closely monitored and periodically asked whether the 
stimulation is producing any discomfort or unusual symptoms (e.g. 
dizziness). At the scalp location of interest, the lowest TMS intensity 
able to elicit 5 visible cessations of EMG activity in 10 trials (AMT), 
or 5 visible twitches in 10 trials (RMT) at this site will be 
determined. Individual MT will be used to determine the intensity of 
stimulation for each individual, as recommended by safety 
guidelines. This procedure usually takes about 5 minutes and also 
serves the purpose of acquainting participants to TMS stimulation. 
Once MT is determined, TMS will be administered within the limits 
of the safety guidelines recently updated in Rossi et al., 2021. An 
additional 12 years of research using TBS ranging between 80% and 
100% RMT was examined to determine the continued efficacy of 
previously established guidelines in Rossi et al., 2009. Since the 
2009 publication, the scientific community has gained a better 
understanding of safety risks and the rarity of adverse events (such 
as seizure) associated with TMS. To reflect current safety guidelines 
for offline studies using TBS, TMS will never exceed 100% of RMT 
or 120% of AMT.
TMS will be delivered to multiple sites of interest. Site order will be 
randomized across participants.
Electroencephalography (EEG) will be used to measure changes in 
brain activity caused by TMS. The EEG assesses electrical brain 
activity through surface recording disks (electrodes) which are 
placed near the participant's head. The electrodes transmit the 
signals, which are then amplified (via an 8 channel Brain Vision 
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LiveAmp) and stored on a computer. The procedure is entirely non-
invasive.
An electrode cap will be placed on the participant's head. In order to 
record brain activity, these disks need to be filled will a gel which 
allows the electrodes to better record brain activity at the scalp. 
Therefore, the participants in this study will need to clean their hair 
after participation. The gel is completely water soluble, and the 
procedure is painless. The MRI facility has sinks and towels, and the 
investigators will help to make sure the participant has thoroughly 
rinsed all the gel from their hair. After an accurate signal is assured, 
the signal derived from the electrode cap is then amplified, 
transmitted to a computer, and stored for later analysis. In addition to 
the EEG recording, muscle activity from around the eyes may be 
recorded from the subjects. Muscle activity from around the eyes is 
recorded by two small sensors that will be placed below the 
participant’s left eye, as well as behind the ears. These procedures 
are completely noninvasive and painless.
6.2
Provide a description of all research procedures being performed 
and when they are performed, including procedures being performed 
to monitor subjects for safety or minimize risks.
Below is a description of the kinds of tasks that participants will 
perform. In general, tasks will range in duration from 5-10 minutes 
to 1-2 hours. Breaks will be given every 5-10 minutes. Multiple 
sessions may be performed. Based upon performance on the tasks, 
we may contact participants to perform other related tasks. Returning 
to perform other tasks will be optional and have no bearing upon the 
tasks the participants have already completed.

Computer-based Tasks 
o
Doors Task 
a.
Participants will be shown graphics 
depicting doors, and will be asked to choose 
a door. After picking a door, participants 
receive feedback on the screen indicating 
whether they have won or lost on that trial. 
The participants’ goal is to do their best to 
win as much money as possible. In this task, 
participants will receive a monetary bonus 
for correct guesses, which will total between 
$0.00 and $10.00 depending on how many 
correct guesses they make. This task will 
take approximately 5-10 minutes.
o
Motivated Behavior Task 
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a.
Participants will be given the opportunity to 
complete a specified number of trials for a 
specified reward. Trials will entail trials of 
the tasks described above or other simple 
cognitive tasks such as arithmetic.
Written tasks
o
DARS
a.
Self-reported anhedonia will be measured 
using the Dimensional Anhedonia Rating 
Scale (DARS). The DARS is an appealing 
measure due to its high internal consistency, 
convergent validity with other measures of 
anhedonia, divergent validity with 
depression scores, and ability to capture 
state levels of anhedonia. This latter 
property makes it suitable for measuring 
changes in anhedonia.
o
Screening
a.
Participants will be screened to be fluent in 
English, between the ages of 18-55, and to 
have no contraindications for MRI or TMS. 
Participants will also be screened such that 
they do not belong to populations vulnerable 
to the Coronavirus Disease (COVID-19), 
and have not been exposed. To be eligible 
for participation in this study, participants 
must score 46 or below on the DARS, 
reflecting increased anhedonia.  
o
Demographics 
a.
Demographic information including age, 
gender, race, and ethnicity will be collected. 
This information will be used for reporting 
purposes to demonstrate fair inclusion. 
Participants will be informed that providing 
this information will be optional. This 
information has no direct bearing upon the 
research to be performed
o
Handedness 
a.
Edinburgh Handedness Inventory, which 
asks about which hand is used in various 
tasks, will be collected to determine the 
dominant hand.
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o
DSM Crosscutting 
a.
The DSM-5 Level 1 Cross-Cutting 
Symptom Measure is a self- or informant-
rated measure that assesses mental health 
domains that are important across 
psychiatric diagnoses.
o
World Health Organization Disability Assessment 
Schedule (WHODAS)
a.
The WHODAS is a generic assessment 
instrument developed by WHO to provide a 
standardized method for measuring health 
and disabilities across cultures.
o
Patient Health Questionnaire (PHQ-9) 
a.
The PHQ-9 is a brief depression severity 
measure.
o
Generalized Anxiety Disorder (GAD-7) 
a.
The GAD-7 is a brief measure for assessing 
generalized anxiety disorder.
o
Quick Inventory of Depressive Symptomatology 
(QIDS-SR) 
a.
The QIDS-SR is a brief self-report 
assessment of depressive symptoms.
o
Pain scale 
a.
Self-reported pain scale.
o
Depression Anxiety and Stress Scale (DASS 21) 
a.
a 21-item questionnaire to assess symptoms 
of depression, anxiety and stress.

Interviews
o
Montgomery-Asperg Depression Rating Scale 
(MADRS) 
a.
The MADRS is a diagnostic questionnaire to 
measure the severity of depressive episodes.
6.3
Describe:
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
Procedures performed to lessen the probability or magnitude 
of risks.

All drugs and devices used in the research and the purpose of 
their use, and their regulatory approval status.

The source records that will be used to collect data about 
subjects. (Attach all surveys, scripts, and data collection 
forms.)
To lessen the probability or magnitude of risks, researchers will 
stop testing or administer breaks if participants feel frustrated, 
tired, and/or uncomfortable. Additionally, the occurrence of 
any adverse events associated with this study and its 
procedures, as well as any changes in risk level, will be 
monitored by the principal investigator and co-investigators
For fMRI, additional risks and preventions include: 1) 
Magnetic field attracting ferromagnetic objects: Subjects will 
be screened for metallic objects prior to entering the scan room 
to minimize this risk and anyone with a questionable history of 
metal will not be allowed to enter the scanner room. 2) 
Claustrophobia: Any participant reporting the experience of 
claustrophobia will be removed from the magnet immediately, 
debriefed, and given compensation for their time. 3) Noise: All 
participants will be required to wear ear plugs to shield them 
from scanner noise while allowing communication from the 
technician. If the noise is overly bothersome to the subjects, 
they will be removed from the magnet immediately. Please 
note: The occurrence of any adverse events associated with this 
study and its procedures, as well as any changes in risk level 
will be monitored by the principal investigator and 
coinvestigators of this study, as well as the scanner technician.
For TMS, the most severe risk is that of seizure. The risk of 
seizure will be minimized in two ways 1) Using stimulation 
parameters that are within the safety guidelines reported by 
Rossi et al., 2009 and updated by Rossi et al., 2021, and 2) 
Screening and excluding participants with increased seizure 
risk as indicated by Rossi et al., 2009 and Rossi et al., 2021. As 
extensively detailed in section 15.1 below, risk for seizure is 
very low, even for individuals with elevated risk. Due to our 
interest in individuals with elevated anhedonia, we will not be 
able to exclude individuals with psychiatric disorders (i.e. 
major depression) and/or individuals receiving medications to 
treat psychiatric disorders, both of which increase seizure risks. 
However, we will screen for other factors that increase seizure 
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risks and exclude participants accordingly. See section 15.1 for 
further details of seizure risks.  
Personnel who administer TMS will be trained to recognize a 
potential seizure event and to act as first responders in order to 
administer appropriate initial care. In addition, all study 
personnel will be trained in Basic Life Support and CPR usage. 
However, we wish to emphasize that there are no known cases 
where individuals required the use of CPR during a TMS 
session. The major physical signs the study personnel will look 
out for in detecting a potential seizure include chewing 
movements, convulsions/tremor/shaking, difficulty talking, a 
blank stare, eyes rolling up, and profuse sweating. If any of 
these signs are observed, study personnel will stop the research 
procedure and inquire whether the subject feels okay. If the 
subject is unresponsive (and therefore likely experiencing a 
seizure), first-aid will be supplied. The first-aid response 
consists of making sure the subject is physically safe for the 
duration of the seizure. This involves moving the subjects out 
of the TMS chair and onto the floor lying down on their left 
side. The subject will be kept lying down on their left side, 
while the staff call emergency medical help, via a 911 call. 
Resources available in the laboratory include a first-aid kit and 
immediate phone access. In the extremely unlikely event of an 
actual occurrence of a seizure, it will be immediately reported 
to the IRB. To minimize headaches and/or other forms of 
discomfort, the experimenter will encourage participants to 
report any form of discomfort during the procedure. The 
experimenter will periodically directly query the participant 
regarding whether or not they are experiencing discomfort. In 
addition, an arm will be used to help support the coil to reduce 
downward pressure on the subject that could lead to neck 
discomfort. The experimental procedure will be immediately 
terminated whenever anyone reports experiencing discomfort. 
To prevent adverse effects on hearing due to the sound 
produced by TMS, all experimental participants will wear ear 
plugs.
In order to ensure that personnel are qualified to administer 
TMS, all personnel to be added to this protocol will receive a 
minimum of 10 hours of training with an experienced TMS 
administrator. In addition to training, personnel will be 
required to read safety documentation consisting of Rossi et al., 
2009, and Oberman et al., 2011. Prior to being permitted to 
administer TMS, all personnel will meet with Dr. Derek Nee to 
ensure understanding of the TMS procedure and all potential 
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contraindications. All personnel will receive CPR training and 
CITI training. Additionally, all personnel will be instructed on 
how to deal with a seizure.
The source records that will be used to collect data about 
subjects will be retained in digital format. Digital information 
will be stored on password protected local machines, or on 
secure cloud-based services such as Google Docs, also 
requiring a password.
Due to the COVID-19 national emergency and pandemic, 
researchers will also apply the following precautions in 
conducting this research: 

No persons deemed as higher risk by the CDC will be 
included in the study. Participants will be screened such 
that they meet these requirements. 

COVID-19 related risks will be mitigated as much as 
possible. This will be done through screening for exposure 
to COVID-19, regular cleaning and disinfecting study 
areas, reducing in-person interactions, and use of personal 
protection equipment. 

To prevent the spread of pathogens during TMS, 
participants may be given a disposable face mask. 
Administered masks will contain no metal so as to be 
compatible with TMS.
For in-person study activities involving prospective subjects and 
study staff, we will as part of our screening and eligibility 
procedures implement the option of informing subjects and staff 
that their voluntary disclosure of their full COVID-19 
vaccination status is an alternative to the requirement for 
COVID-19 precautions such as social distancing, use of masks, 
and other safety precautions. In doing so, we will use the 
following language: “In order to protect against COVID-19 or 
Coronavirus, if you come to the lab we are required to follow 
certain precautions like social distancing and use of masks. 
However, we don’t have to do this for persons who have 
completed a full COVID-19 vaccination. You may if you’d like 
share with us information about your COVID-19 vaccination, 
but this is your decision and is not required. You can still come 
to the lab and we will follow our usual COVID-19 precautions."
To implement this COVID-19 vaccination option, we will make 
a note in our study records for each prospective subjects and 
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staff who choose to disclose their COVID-19 vaccination 
information
6.4
What data will be collected during the study and how that data will 
be obtained.
The data that will be collected during the study includes identifying 
information. Additionally, brain activations, accuracies and reaction 
times to tasks will be collected. The data will be obtained using 
computerized-based tasks or written tasks while being tested in the 
MRI scanner.
6.5
If there are plans for long-term follow-up (once all research related 
procedures are complete), what data will be collected during this 
period. 
In some cases, performance in some tasks will trigger eligibility for 
other tasks. In these cases, procedures will be identical to those 
described above.
6.6
For Humanitarian Use Device (HUD) uses provide a description of 
the device, a summary of how you propose to use the device, 
including a description of any screening procedures, the HUD 
procedure, and any patient follow-up visits, tests or procedures.
NA
7.0
Data and Specimen Banking*
7.1
If data or specimens will be banked for future use, describe where 
the specimens will be stored, how long they will be stored, how the 
specimens will be accessed, and who will have access to the 
specimens.
NA
7.2
List the data to be stored or associated with each specimen.
NA
7.3
Describe the procedures to release data or specimens, including: the 
process to request a release, approvals required for release, who 
can obtain data or specimens, and the data to be provided with 
specimens.
NA
8.0
Sharing of Results with Subjects*
8.1
Describe whether results (study results or individual subject results, 
such as results of investigational diagnostic tests, genetic tests, or 
incidental findings) will be shared with subjects or others (e.g., the 
subject’s primary care physicians) and if so, describe how the results 
will be shared.
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The MRIF contracts with The Mind Research Network (MRN) for 
screening of all subjects. To this end, subjects electing to partake in 
the IF program will have their T1 and T2 weighted scan data sent to 
MRN via encrypted data link. Other scans such as Susceptibility 
Weighted Images (SWI), Diffusion Weighted Images (DWI), and 
Fluid-attenuated Inversion Recovery (FLAIR) can also be send to 
MRN for review, if needed.
The MRN Contracted Radiologists will review images provided to 
them, and do not have access to additional clinical information. The 
MRI scans are collected under research protocols and are not 
obtained for clinical purposes.
The research MRI scans are not a substitute for a clinical scan and 
might not show problems that may be picked up by a clinical scan. If 
MRNs find an abnormality that requires follow-up, they may also 
mail a copy of the report to the subject, or contact them (with their 
permission), to help answer questions.
All MRN radiology reviews are completed within 30 days and are 
forwarded as a de-identified report directly to the MRI Technologist. 
All reports are then printed and mailed via US Postal Service to the 
subject’s mailing address. They are provided with the contact 
information of the MRI Technologist in case they have questions. 
Any returned reports will be recorded and the hard copy destroyed.
9.0
Study Timelines*
9.1
Describe:

The duration of an individual subject’s participation in the 
study.

The duration anticipated to enroll all study subjects.

The estimated date for the investigators to complete this study 
(complete primary analyses)
The duration for each individual’s participation will be between 30 
minutes and 2 hours per session. Participants will participate in at 
least 1, and potentially several sessions. It may take up to several 
weeks to complete an entire task. The duration anticipated to enroll 
all study subjects is 72 months.
10.0
Inclusion and Exclusion Criteria*
10.1 Describe how individuals will be screened for eligibility.
Participants will be screened in order to minimize risks associated 
with TMS and fMRI. Screening will proceed with a combination of 
e-mail, phone, and in person questions. First, the screening forms 
will be sent to the participant via e-mail (see Appendix), performed 
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over the phone, or both. If the participant passes the first phase of 
screening and remains interested in participating, the participant will 
be invited to perform the study. Participants will read the consent 
form and any questions will be answered. Screening for TMS will be 
completed again in each experimental session to assess if any 
changes have occurred prior the last screening. The individuals 
included in this study will be adults from ages 18 to 55.
We will also exclude from study individuals who are vulnerable to or 
may have come in contact with COVID-19. We will include 
individuals who have completed a full FDA-authorized vaccination 
series at least 14 days before the study session, and individuals who 
have not been fully vaccinated provided that they pass the screening 
process. As with the other screening forms, the COVID-19 screening 
form will be sent to the participant via e-mail (see Appendix). The 
participant will be asked to respond with whether the answer to 
question #1 on the form is “yes” or if, alternatively the answer to #1 
is “no” and the answer to any other question on the screening form 
(#2 through #8) is “yes.” Question #1 asks participants to indicate if 
they have received a complete vaccination series, the specific FDA-
approved vaccine product they received, and the date of vaccination. 
At this phase, the participant does not need to indicate which to 
which of the other questions the answer is “yes.” If the response is 
“yes” to any questions including #2 through #8, the participant will 
be excluded. If the participant passes the first phase of screening and 
remains interested in participating, the participant will be invited to 
perform the study. Participants will read the consent form and any 
questions will be answered. After answering questions, the 
participant will once again be presented with the screening form. In 
this case, the participant will fill-out the screening form. If the 
answer is “no” to #1 and “yes” to any of the other questions (#2 
through #8), the participant may be asked to elaborate. A “yes” 
response may occur in the second screening, but not the first, if 
circumstances changed since the initial screening.
Finally, screening for this study will also involve completing the 
Dimensional Anhedonia Rating Scale (DARS); only participants 
who score 46 or below (i.e., those who endorse increased anhedonia) 
are eligible.  
. 
10.2 Describe the criteria that define who will be included or excluded in 
your final study sample.
Inclusion: Because we are interested in the mental function of adults 
prior to any age-related decline, participants will be between the ages 
of 18-55. Participants will also need to be fluent in English and have 
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acquired fluency prior to the age of 6 since English is required to 
understand the instructions. Because of the visual presentation of 
stimuli, participants will need to have normal or corrected-to-normal 
vision. Only participants who score 46 or below on the Dimensional 
Anhedonia Rating Scale (DARS) are eligible.   
Exclusion: Left-handed people will be excluded. Many brain 
functions are lateralized (e.g. language is often processed by the left 
hemisphere). While such lateralization is typically very consistent in 
right-handers, brain lateralization is less predictable in left-handers 
which can confound localization of function. Participants must pass 
the MRI screening protocol, excluding people who have metal in any 
portion of the body, have medical complications, cardiac pacemaker 
cochlear implant, aneurysm clip, IUD shrapnel, history of metal 
fragments in eyes, neurostimulators, weight over 300 pounds, known 
problems of claustrophobia, or illicit drug use. Because alcohol has a 
transient effect on neural activity, subjects will be screened to have 
not consumed alcohol for the past 24 hours via self-report. 
Additionally, people with the following will be excluded: hearing 
impairments and permanent retainers on the top portion of their jaw. 
A screening form (attached) will be used to assess each subject’s 
eligibility for participation.
Based on recommendations of the International Workshop on the 
Safety of Repetitive Transcranial Magnetic Stimulation (reported in 
Wassermann, 1998), as well as the recommendations of Rossi et al., 
2009 and Rossi et al., 2021, we will exclude subjects on any of the 
following grounds: Metal anywhere in the head, excluding the 
mouth, History of seizures, Family history of epilepsy, Vascular, 
traumatic, tumoral, infectious, or metabolic lesion of the brain, 
Stroke, Chronic, or transient insomnia (e.g. jet lag), Alcoholism, 
Severe headaches, Cardiac pacemakers, Tinnitus, and Pregnancy. 
While the health risks to the fetus are unknown, magnetic field 
strength decreases approximately with the cube-root of the distance 
from the magnetic coil. Therefore, a coil located on the scalp will 
have little direct effect on the abdomen, though changes in neural 
firing or emotional stress levels could in theory have distal impact. 
Nevertheless, any person who is pregnant will be excluded from the 
study. A screening form (attached) will be used to assess each 
subject's eligibility for participation. In addition the above, the 
following exclusion criteria will be applied:
1. Medical contraindication for neuromodulation and/or MRI (e.g., 
ferrous metal in head, seizure disorder, brain tumor, stroke, 
aneurysm, multiple sclerosis, etc.)
2. Active substance use disorder in last 3 months or any current 
substance use that puts the participant at increased risk or 
significant impairment
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3. Dementia or other cognitive disorder making unable to engage in 
treatment
4. Any history or diagnosis of Schizophrenia, Schizoaffective 
Disorder, delusional Disorder or other psychotic illness that 
precludes safe participation in trial
5. Suicidal risk that precludes safe participation defined as clinical 
impression that the participant is at significant risk for suicide
6. OCD cannot be the primary disorder but can have OCD symptoms
7. Inability to stop taking any medication that significantly lowers the 
seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
8. Current, planned, or suspected pregnancy
9. Unstable medical conditions or any current medical condition that 
could preclude being able to safely participate in TMS treatment 
(e.g., unstable metabolic abnormality, unstable angina, etc.)
10. Severe Traumatic Brain Injury
11. We will exclude non-English speakers because of the need for 
rapid communication during the delivery of treatments
12. Significant ongoing litigation or claims that impact research activities, as 
determined by the research study team. (Research may especially be 
impacted when mental health or pain is being evaluated for litigation or 
claims, such as civil and criminal cases, disability claims and worker’s 
compensation).
10.3 Indicate specifically whether you will include or exclude 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.)

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners
Special populations will not be studied.
11.0
Vulnerable Populations*
11.1 If the research involves individuals who are vulnerable to coercion 
or undue influence, describe additional safeguards included to 
protect their rights and welfare.
NA
12.0
Local Number of Subjects
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12.1 Indicate the total number of subjects to be accrued locally.
The total number of subjects to be accrued locally is 150. 
12.2 If applicable, distinguish between the number of subjects who are 
expected to be enrolled and screened, and the number of subjects 
needed to complete the research procedures (i.e., numbers of 
subjects excluding screen failures.)
NA
13.0
Recruitment Methods
13.1 Describe when, where, and how potential subjects will be recruited.
Recruitment will be conducted at Florida State University at least 
one hour before testing. Potential subjects will be recruited via 
voluntary responses to flyers posted around campus, at the FSU 
Behavioral Health Clinic at Apalachee Center Clinic, FSU 
Psychology Clinic, community spots (i.e. coffee shops and 
restaurants) and responses to approved electronic postings (see 
Appendix). In addition, subjects may be reached out to via an ‘Okay 
to be Contacted’ list that was collected/provided by Dr. F. Andrew 
Kozel, a member of the FSU College of Medicine (FSU STUDY 
#STUDY00002548: FSUN Future Contact Registry), via the SONA 
system at FSU where potential subjects will read about and sign up 
for the study on the SONA system or via ResearchMatch which is a 
national electronic, web-based recruitment tool that was created 
through the Clinical & Translational Science Awards Consortium in 
2009 and is maintained at Vanderbilt University (they maintain the 
IRB approval for the Research Match database creation and 
recruitment). Additionally, flyers will be given to participants who 
have volunteered for similar studies. (A paper flyer will be given to 
participants who have volunteered for similar studies after they have 
completed the study. These participants will have completed a study 
in a lab at Florida State University that uses similar methods to us 
and has agreed to hand out flyers for our studies to their 
participants). Volunteers will email or call a trained research 
technician who will screen the subject by the stated criteria. DARS 
will be completed electronically to identify eligible participants. 
Potential subjects that pass initial screening will be instructed to 
meet either in the Nee lab in the Psychology Building, Hajcak lab in 
the Psychology Building, or the MRI facility at the College of 
Medicine. All of these are private and secure locations requiring key 
card access.
13.2 Describe the source of subjects.
The source of subjects will be from Florida State University or the 
local community as long as subjects are eligible based on inclusion 
and exclusion criteria.
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13.3 Describe the methods that will be used to identify potential subjects.
The methods used to identify potential subjects include the inclusion 
criteria (e.g., having scored 46 or below on the DARS) and “no” 
responses to TMS and MRI screening questions.
13.4 Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For advertisements, 
attach the final copy of printed advertisements. When advertisements 
are taped for broadcast, attach the final audio/video tape. You may 
submit the wording of the advertisement prior to taping to preclude 
re-taping because of inappropriate wording, provided the IRB 
reviews the final audio/video tape.)
Materials to recruit subjects include an online advertisement and 
recruitment advertisements posted throughout Florida State 
University, community spots, the FSU Psychology Clinic, and the 
Apalachee Center Clinic.  These documents are attached, along with 
a sample recruitment email response from a researcher.
13.5 Describe the amount and timing of any payments to subjects.
Participants will receive $20 per hour. Paid participants may also 
receive a performance-based bonus as incentive to perform the task 
to the best of their ability. Such incentives will only be available to 
paid participants and will be based upon accuracy and speed on the 
tasks and will tend to total $0-$10 per hour. In the event of a 
multisession study, paid participants may also receive a completion 
bonus. Participants that withdraw from the study prior to completion 
will receive prorated compensation (either monetary or credit hours) 
commensurate with the duration of participation. Lastly, monetary 
compensation or credit hours will be awarded once the study is 
complete, or after the subject withdraws from the study.
14.0
Withdrawal of Subjects*
14.1 Describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent.
Anticipated circumstances under which subjects will be withdrawn 
from the research without their consent include inattentiveness, 
damage to research equipment, clear misunderstanding of task 
instructions, and inappropriate behavior such as yelling or swearing.
14.2 Describe any procedures for orderly termination.
NA
14.3 Describe procedures that will be followed when subjects withdraw 
from the research, including partial withdrawal from procedures 
with continued data collection.
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Procedures that will be followed when subjects withdraw from the 
research, including partial withdrawal from procedures with 
continued data collection, include appropriate compensation for their 
time and safekeeping of their data in appropriate records. Identifying 
information will be retained in digital format. Digital information 
will be stored on password protected local machines, or on secure 
cloud based services such as Google Docs also requiring a password.
15.0
Risks to Subjects*
15.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in 
the research. Include as may be useful for the IRB’s consideration, a 
description of the probability, magnitude, duration, and reversibility 
of the risks. Consider physical, psychological, social, legal, and 
economic risks.
Risks for the study include:
Frustration from poor performance on the task, fatigue, or 
eye-strain
Probing for personal or sensitive information in surveys, 
interviews, or questionnaires.
Risks from MRI:
o
Magnetic field attracting ferromagnetic objects. 
There is a potential risk of the main magnet field 
attracting ferromagnetic/metallic objects towards 
the magnet.
o
Claustrophobia. The magnet is a small enclosed 
space that can induce feelings of claustrophobia.
o
Noise. The scanner makes a bothersome/loud noise 
during the course of data collection. This can 
damage hearing if measures are not taken to protect 
the ears.
Risks from EEG:
Risks are minimal. The EEG recording is completely non-
invasive. The EEG will be recorded with a gel-based 
system. There is the possibility that some participants will 
experience mild, temporary itching or tingling sensation in 
response to the electrode cap or electrode gel. This is 
neither harmful nor permanent. During the EEG recording, 
there is a small possibility of mild skin irritation (redness) 
where the electrode contacts the skin. However, this is rare 
and temporary. If a participant is afraid of needles, there is 
a chance that they may become dizzy or lightheaded at the 
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sight of the plastic syringes that we use to put gel in the 
EEG cap – they are not sharp, but because they look a little 
like needles, they might make the participant anxious.
Risks from TMS:
GENERAL INFORMATION TMS is applied through a 
magnetic stimulator. This device consists of a set of 
electrical capacitors which can store and rapidly discharge 
electricity into a coil of electrical wire that is encased in 
shielded plastic. We will use MagPro X100 Magnetic 
Stimulator equipped for a figure 8 (i.e. butterfly) coil 
(MCF-B65) and a flex arm for coil positioning. The 
stimulator is manufactured by MagVenture, which is one of 
the most established manufacturers of TMS equipment with 
arguably the best currently available products and an 
excellent safety record. The coil is placed adjacent to the 
scalp above the targeted region. As the electrical current 
flows through the coil, a magnetic field is generated. The 
field passes through the skin and skull, inducing a brief 
change in the electrical flow of current in the brain. The 
magnetic pulse briefly alters neural activity in brain areas 
lying directly beneath the coil, presumably by causing 
discharge of neurons to a depth of 1.5 to 2.0 cm below the 
scalp. TMS has been used in a large number of laboratories 
worldwide for over 30 years. When administered within 
documented safety guidelines, adverse effects associated 
with TMS are rare. The risk of such adverse effects 
depends greatly on the form of stimulation employed. 
Below, various risks and side effects are described with an 
account of the likelihood of each effect under the proposed 
stimulation conditions. The primary sources for this 
information come from the recommendations of the 
International Workshop on the Safety of Repetitive 
Magnetic Stimulation, June 57, 1996 (reported in 
Wassermann, 1998). A new set of guidelines was published 
in 2009 (Rossi et al., 2009) based on a consensus 
conference which took place in Certosa di Pontignano, 
Siena (Italy) in 2008, and has recently been updated (Rossi 
et al., 2021). Our proposed studies fall firmly within these 
established safety guidelines. There are no known long-
term health risks to the use of TMS per se when operated 
within consensus safety guidelines (Rossi et al., 2009; 
Rossi et al., 2021). In 2008, the FDA approved the use of 
high frequency TMS in the treatment of depression. Also in 
2008, an international consensus conference on safety 
guidelines for TMS met. Their report (Rossi et al., 2009) 
systematically reviewed the thousands of healthy subjects 
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and patients who have undergone TMS in order to allow for 
a better assessment of relative risks. The relative 
infrequency of adverse events using TMS was noted. They 
concluded that in the case of Class 3 studies (studies 
involving indirect benefit and low risk in normal subjects 
and patients that are expected to yield important data on 
brain physiology or safety, but have no immediate 
relevance to clinical problems), normal volunteers should 
be permitted to participate in TMS research. They also 
concluded that this research can be performed in a 
nonmedical setting (i.e., psychology labs, robotics labs, 
research institutions, etc. as opposed to a hospital or 
appropriately equipped outpatient clinic). The Rossi et al. 
(2009) consensus report went on to suggest safety 
guidelines based on the now rather extensive international 
experience with TMS, which were updated in Rossi et al., 
2021. These guidelines include the TMS intensity and 
timing parameters considered safe, training, and planning 
for and managing emergencies. We will follow these 
guidelines, and have incorporated them into our screening 
and session procedures. The consensus safety guidelines 
(Rossi et al., 2009; Rossi et al., 2021) are included as a 
supporting document attachment with this IRB application. 
The PI on this project (Dr. Nee) has extensive experience 
with TMS during graduate school, post-doctoral studies, 
and at FSU. He received formal training in the 
administration of TMS through an intensive course offered 
by Harvard Medical School 
(http://tmslab.org/educationintensive.php) lead by Dr. 
Alvaro Pascual-Leone, a world leader in non-invasive brain 
stimulation. He has delivered or directly supervised over 
100 sessions of TMS with no serious adverse effects. It is 
important to note that TMS protocols in the literature differ 
with respect to stimulation intensity, frequency, and 
duration. Adverse effects increase as each of these 
variables increases. The TMS protocols to be used in this 
study are reflective of the PI’s previous studies and are 
suggestive of a low incidence of adverse effects with the 
planned stimulation parameters. Here I list the documented 
risks associated with TMS:
Seizure. Seizure is a theoretical risk with TMS. In a 
workshop convened by the National Institute for 
Neurological Disorders and Stroke (NINDS) in 1996, 
researchers in the field agreed upon a set of TMS consensus 
safety guidelines, including recommended stimulation 
parameters and contraindications (Wasserman, 1998), and 
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these consensus guidelines have been updated (Rossi et al., 
2009; Rossi et al., 2021). Widespread adherence to the 
1996 guidelines has resulted in the virtual elimination of 
inadvertent seizures in TMS studies (Rossi et al., 2009). 
The levels of stimulation used in this protocol are well 
within safety guidelines (Rossi et al., 2009; Rossi et al., 
2021). In the Rossi et al. (2021) report it was stated that 
"the risk of rTMS in inducing a seizure is definitely low, 
even in patient populations taking drugs acting on the 
central nervous system, at least with the use of traditional 
stimulation parameters and focal coils.” These conclusions 
were based upon an estimated risk for seizures in single, 
paired, and low frequency stimulation paradigms to be 
8/100,000 sessions across high and low-risk subjects, and 
7/100,000 sessions in repetitive TMS (rTMS) paradigms. 
Individuals at elevated risk (see paragraph below) were 
reported to have a standardized risk of 27/100,000 in 
single, paired, and low-frequency TMS, and 67/100,000 in 
rTMS.
The following are considered factors that place participants 
at elevated risk for seizures: sleep deprivation, 
stress/anxiety, metabolic abnormalities, raised blood 
concentrations of proconvulsant medications, alcohol 
withdrawl, use of stimulations such as cocaine or MDMA, 
use of immunosuppressive therapy with agents that can 
cause the posterior reversible leukeoencephalopathy 
sundrome, diaysis, systemic infection, and fever. In 
addition, individuals with epilepsy and other neurological 
conditions are at elevated risk for seizures. Elevated seizure 
risk has also been reported in psychiatric conditions 
including major depression, schizophrenia, autism, bipolar 
disorder, and alcohol abuse. The presence of any of these 
factors would cause an individual to be considered at 
elevated risk of seizure, and therefore, at elevated risk of a 
TMS-induced seizure. Our TMS screening form is designed 
to exclude individuals at elevated risk of seizure from these 
causes with the following exception: since we are interested 
in individuals with elevated anhedonia, we will not exclude 
individuals with psychiatric conditions (e.g. major 
depression) nor individuals who are taking medications to 
treat psychiatric conditions. With regard to the latter, the 
safety guidelines of the Rossi et al., 2009 originally advised 
caution with regard to medication status, but after further 
study, the Rossi et al., 2021 guidelines state that “the 
currently available data showing low seizure rate no longer 
support this recommendation.” Therefore, medication 
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status is not considered to confer undue risk. Although risk 
may be elevated for individuals with psychiatric conditions, 
we note that patients with major depression are among the 
most studied population with TMS and form a large part of 
the basis of the conclusions of Rossi et al., 2021 that 
“seizure risk is definitely low.” As a result, Rossi et al., 
2021 indicate that psychiatric populations are not 
contraindicated for TMS, but “it remains necessary to be 
prepared to deal with a seizure that might arise in any 
experimental protocol.” We will thus take steps to be 
prepared as follows:
Personnel who administer TMS will be trained to recognize 
a potential seizure event and to act as first responders in 
order to administer appropriate initial care. In addition, all 
study personnel will be trained in Basic Life Support and 
CPR usage. However, we wish to emphasize that there are 
no known cases where individuals required the use of CPR 
during a TMS session. The major physical signs the study 
personnel will look out for in detecting a potential seizure 
include chewing movements, convulsions/tremor/shaking, 
difficulty talking, a blank stare, eyes rolling up, and profuse 
sweating. If any of these signs are observed, study 
personnel will stop the research procedure and inquire 
whether the subject feels okay. If the subject is 
unresponsive (and therefore likely experiencing a seizure), 
first-aid will be supplied. The first-aid response consists of 
making sure the subject is physically safe for the duration 
of the seizure. This involves moving the subjects out of the 
TMS chair and onto the floor lying down on their left side. 
The subject will be kept lying down on their left side, while 
the staff call emergency medical help, via a 911 call. 
Resources available in the laboratory include a first-aid kit 
and immediate phone access. In the extremely unlikely 
event of an actual occurrence of a seizure, it will be 
immediately reported to the IRB.
Local pain, headache, or discomfort. The most commonly 
reported side effect of TMS is headache. This headache is 
typically of a muscle-tension type. It usually develops 
during or immediately after the stimulation and may last for 
minutes to hours following the end of the stimulation. It is 
typically limited to the day of stimulation. Neck pain or 
scalp pain may also occur. Both are usually managed easily 
with over-the-counter analgesics. The experimental 
procedure will be immediately terminated whenever 
anyone reports experiencing discomfort. There are no 
reports of any such effects recurring. For many scalp 
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locations, TMS feels only like a sudden tap on the scalp 
accompanied by a clicking sound. For other scalp locations, 
TMS can cause face or limb twitches. These twitches are 
not painful, but can feel odd or disquieting when first 
experienced. On some occasions, TMS might cross the 
threshold to the point where it would actually be described 
as producing a slightly painful scalp sensation. We will 
closely monitor subjects' comfort and will request them to 
tell us if the stimulation ever feels painful. If this occurs, 
we will immediately decrease TMS intensity to a level that 
is not painful. It is important to note that the likelihood of 
headache and other discomfort depends upon the 
stimulation parameters. Parameters for clinical applications 
for depression note a rate of 28% for pain, which is greater 
than the 16% observed for sham (i.e. no true stimulation; 
Loo et al., 2008). However, for TBS, the rate is less than 
3% (Oberman et al., 2011). In many cases, discomfort can 
be due to neck pain resulting from holding one’s head still 
against the coil. The figure 8 coil (MCF-B65) is lightweight 
compared to most coils and will be supported by an arm for 
positioning that alleviates downward pressure on the 
subject. Therefore, we anticipate rates of adverse effects 
due to pain and discomfort will be low and in accordance 
with the PI’s previous history with the technique.
Transient hearing changes. TMS produces an audible 
clicking noise when the current passes through the coil. 
This click can result in tinnitus and transient decreased 
hearing if no protection is used. To prevent this adverse 
effect, all experimental participants will wear ear plugs. 
Animal and human studies have demonstrated that earplugs 
can effectively prevent the risk of hearing disturbances or 
discomfort due to TMS. The experimenters will also be 
provided with ear protection devices to minimize any 
discomfort they might experience from the clicks.
Transient cognitive/neuropsychological changes. Some 
repetitive TMS protocols have been shown to affect 
cognitive processing for up to one hour following 
stimulation. Specifically, this is the case for "offline" 
techniques such as 1 Hz stimulation and theta-burst 
stimulation (TBS; Huang et al., 2005). These changes are 
small, but could in theory affect the subject's ability to 
drive home safely. However, our use of offline TMS 
always precedes the actual experimental task that subjects 
are performing. Since the effects of the TMS parameters we 
are proposing to use have never been observed to last more 
than 1 hour, the potential cognitive effects of TMS are 
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expected to have worn off by the time the testing session is 
concluded. Participants may experience frustration from 
poor performance on the task. Another potential risk is 
probing for personal or sensitive information in surveys, 
interviews, or questionnaire.
Although we do not expect it to occur frequently, some 
subjects may endorse suicidality or increased risk for 
suicidality; in this event, we will implement the 
following protocol:
Participants will have a clinical interview performed, and 
as part of that clinical interview, we will assess 
suicidality. If participants endorse any suicidal ideation, 
the severity of suicidality will be assessed using the 
structured interview on the following pages, and the 
Joiner method. This procedure is adopted from the FSU 
Psychology Clinic using the clinic’s suicide decision 
tree, which is an empirically validated structured 
interview.
Joiner et al. (1999) use the following method to 
designate risk severity:
1.
An individual’s risk for suicide is designated 
nonexistent if he or she has no current suicidal 
symptoms, no history of suicide, and no or few other risk 
factors.
2.
Risk for suicide is considered mild if the 
individual is a multiple attempter with no other risk 
factors or is a non-multiple attempter experiencing 
suicidal ideation of limited intensity and duration, no or 
mild Resolved Plans and Preparation, and no or few 
other risk factors.
3.
An individual is designated at moderate risk if he 
or she is a multiple attempter with any other significant 
risk factor. A non-multiple attempter with moderate to 
severe Resolved Plans and Preparations or moderate to 
severe Suicidal Desire and Ideation accompanied by at 
least two other risk factors is also considered to be at 
moderate risk for suicide.
4.
A multiple attempter with two or more risk 
factors or a non-multiple attempter with moderate to 
severe symptoms of Resolved Plans and Preparations 
accompanied by one other risk factor is designated at 
severe risk for suicide.
5.
An individual is at extreme risk for suicide if he 
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or she is a multiple attempter with severe Resolved 
Plans and Preparation or is a non-multiple attempter 
with Resolved Plans and Preparations and two or more 
other risk factors.
Once an individual has been assessed for suicide 
risk, we will take the following actions, as suggested 
by Joiner et al. (1999):
For any participant with suicidal ideation, phone 
numbers for mental health resources will be provided. 
At their request, participants will be referred to 
clinicians from the FSU Psychology Clinic, with 
whom they may speak about their discomfort or 
distress.
1.
If an individual is considered to be at mild risk, 
he or she will be instructed to use self-control strategies 
and to seek out social support in the event that he or she 
becomes suicidal (Safety Card). If these strategies fail, 
he or she will be instructed to contact an emergency 
mental health resource or go to the emergency room, the 
phone numbers for which will be provided.
2.
A person who is at moderate risk for suicide will 
be given a card with a list of steps to follow in case of 
emergency (Safety Card), which will also contain phone 
numbers for emergency: 911, 211 (Tallahassee’s crisis 
line), 1800273TALK (National Suicide Prevention 
Lifeline). He or she will also be given an offer to go to 
the FSU Psychology Clinic with the interviewer for 
further care, if desired. Dr. Hajcak (Associate 
Investigator) will be consulted with immediately for any 
risk greater than minimal.
3.
Someone who is at severe or extreme risk for 
suicide will be given an offer to go to the FSU 
Psychology Clinic with the interviewer for further care. 
If the risk is imminent and serious, then the University’s 
Crisis Management Unit (appropriate mental health 
providers for suicidal crisis) will be contacted. If he or 
she refuses such hospitalization (or further care at the 
FSU Psychology Clinic), the experimenter will call 911 
so that the police can escort the participant to further 
care.
For additional details, see the accompanying interview and 
safety plan card in the appendix.
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15.2 If applicable, indicate which procedures may have risks to the 
subjects that are currently unforeseeable.
NA
15.3 If applicable, indicate which procedures may have risks to an 
embryo or fetus should the subject be or become pregnant.
NA
15.4 If applicable, describe risks to others who are not subjects.
NA
16.0
Potential Benefits to Subjects*
16.1 Describe the potential benefits that individual subjects may 
experience from taking part in the research. Include as may be 
useful for the IRB’s consideration, the probability, magnitude, and 
duration of the potential benefits.
No direct benefit.
16.2 Indicate if there is no direct benefit. Do not include benefits to 
society or others.
No direct benefit.
17.0
Data Management* and Confidentiality
17.1 Describe the data analysis plan, including any statistical procedures 
or power analysis.
Data analysis will follow standard procedures detailed in the relevant 
literature including frequentist tests and Bayesian statistics when 
applicable. Power analyses will be performed on relevant past and/or 
preliminary data to inform planned sample sizes. If such data are no 
available, power analyses will be performed based on anticipated 
effect sizes.
17.2 Describe the steps that will be taken to secure the data (e.g., 
training, authorization of access, password protection, encryption, 
physical controls, certificates of confidentiality, and separation of 
identifiers and data) during storage, use, and transmission.
The steps that will be taken to secure the data (e.g., training, 
authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers 
and data) during storage, use, and transmission include retaining 
information in digital format. Digital information will be stored on 
password protected local machines, or on secure cloud based 
services such as Google Docs also requiring a password.
17.3 Describe any procedures that will be used for quality control of 
collected data.
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NA
17.4 Describe how data or specimens will be handled study-wide:

What information will be included in that data or associated 
with the specimens?

Where and how data or specimens will be stored?

How long the data or specimens will be stored?

Who will have access to the data or specimens?

Who is responsible for receipt or transmission of the data or 
specimens?

How data or specimens will be transported?
NA
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*
This section is required when research involves more than Minimal Risk 
to subjects.
18.1 Describe:

The plan to periodically evaluate the data collected regarding 
both harms and benefits to determine whether subjects remain 
safe.  The plan might include establishing a data monitoring 
committee and a plan for reporting data monitoring committee 
findings to the IRB and the sponsor.

What data are reviewed, including safety data, untoward 
events, and efficacy data.

How the safety information will be collected (e.g., with case 
report forms, at study visits, by telephone calls with 
participants).

The frequency of data collection, including when safety data 
collection starts.

Who will review the data.

The frequency or periodicity of review of cumulative data.

The statistical tests for analyzing the safety data to determine 
whether harm is occurring.

Any conditions that trigger an immediate suspension of the 
research.
NA
19.0
Provisions to Protect the Privacy Interests of Subjects
19.1 Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place 
limits on whom they interact or whom they provide personal 
information.
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The steps taken to protect subjects’ privacy interests include testing 
in a private and secure location requiring keycard access. Subjects 
will be consented and screened individually in a testing room, where 
he or she will have contact with trained personnel identified in this 
application.  During the consenting process, the participant will only 
have contact with trained personnel identified in this application.
19.2 Describe what steps you will take to make the subjects feel at ease 
with the research situation in terms of the questions being asked and 
the procedures being performed. “At ease” does not refer to 
physical discomfort, but the sense of intrusiveness a subject might 
experience in response to questions, examinations, and procedures.
Subjects will be able to stop or leave at any moment. Additionally, 
trained personnel will deliver instructions and provide information 
regarding where to go if they have questions. An exception is if the 
participant’s responses indicate that they may be at imminent risk for 
suicide or harming oneself or others. In these cases, one of the 
trainee clinicians will be notified and will contact the participant 
with beneficial information and further resources. Resources include 
self-help plans, crisis line numbers, referral information to mental 
health clinics, and if necessary for their safety, notification of 
emergency services.
19.3 Indicate how the research team is permitted to access any sources of 
information about the subjects.
The research team is permitted to access any sources of information 
about the subjects using the digital formats storing subject 
information. Researchers will need to know the passwords or have 
access to view the information.
20.0
Compensation for Research-Related Injury
20.1 If the research involves more than Minimal Risk to subjects, describe 
the available compensation in the event of research related injury.
None
20.2 Provide a copy of contract language, if any, relevant to 
compensation for research-related injury.
Routinely, FSU, its agents, or its employees do not compensate for 
or provide free care for human subjects in the event that any injury 
results from participation in a research project.  If you become ill or 
injured as a direct result of participating in this study, contact your 
regular medical provider.  If you have insurance, your insurance 
company may or may not pay for these costs. If you do not have 
insurance, or if your insurance company refuses to pay, you will be 
billed. Funds to compensate for pain, expenses, lost wages and other 
damages caused by injury are not routinely available.
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21.0
Economic Burden to Subjects
21.1 Describe any costs that subjects may be responsible for because of 
participation in the research.
NA
22.0
Consent Process
22.1 Consent will be obtained:

In person, onsite in the Nee lab or Hajcak lab, prior to the 
collection of data.

There will be no waiting period available between informing 
the prospective subject and obtaining consent.

There will be no process to ensure ongoing consent

HRP-090 consent will not be used.

The individuals listed in the application will tell subjects that 
the purpose of the study is to understand the mental processes 
involved in reward. The participants will also be informed of 
the duration of the experiment, use of fMRI, use of TMS, use 
of EEG, and inclusion and exclusion criteria.

Additionally, participants will be screened in order to minimize 
risks associated with fMRI and TMS. Screening will proceed in 
two phases. First, the screening form will be sent to the 
participant via email (see Appendix). The participant will be 
asked to respond with whether the answer to any question on 
the screening form is “yes”. If the response is “yes” to any 
question, the participant will be excluded. If the participant 
passes the first phase of screening and remains interested in 
participating, the participant will be invited to perform the 
study. Participants will read the consent form and any 
questions will be answered. After answering questions, the 
participant will once again be presented with the screening 
form. If the answer is “yes” to a given question, the participant 
may be asked to elaborate. A “yes” response may occur in the 
second screening, but not the first, if circumstances changed 
since the initial screening. Steps that will be taken to minimize 
the possibility of coercion or undue influence.

Consent discussion will occur prior to data collection. Data 
collection will not occur until subjects understand the study 
outlines and protocol.

Researchers will inform subjects that participation is voluntary 
and they can leave at any moment.

Researchers will ask participants questions regarding 
understanding of the study before proceeding.
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
The consenting process will take as long as any subject needs 
to understand the experiment.

Steps that will be taken to minimize the possibility of coercion 
or undue influence include understanding the task and a formal 
signature on the consent document before proceeding with data 
collection.
Non-English Speaking Subjects

NA
Waiver or Alteration of Consent Process (consent will not be 
obtained, required information will not be disclosed, or the 
research involves deception)

NA
Subjects who are not yet adults (infants, children, teenagers)

NA
Cognitively Impaired Adults

NA
Adults Unable to Consent

NA 
Adults Unable to Consent

NA
23.0
Process to Document Consent in Writing
23.1 Describe whether you will be following “SOP: Written 
Documentation of Consent (HRP-091).” If not, describe whether and 
how consent of the subject will be documented in writing.
Yes, written consent will be obtained.
23.2 If your research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written 
documentation of consent is normally required outside of the 
research context, the IRB will generally waive the requirement to 
obtain written documentation of consent.
23.3 (If you will document consent in writing, attach a consent document. 
If you will obtain consent, but not document consent in writing, 
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attach a consent script. Review “CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)” to ensure that you have 
provided sufficient information. You may use “TEMPLATE 
CONSENT DOCUMENT (HRP-502)”to create the consent 
document or script.)
A consent document is attached.
24.0
Setting
24.1 Describe the sites or locations where your research team will 
conduct the research.

Identify where your research team will identify and recruit 
potential subjects.

Identify where research procedures will be performed.

Describe the composition and involvement of any community 
advisory board.

For research conducted outside of the organization and its 
affiliates describe:
o
Site-specific regulations or customs affecting the 
research for research outside the organization.
o
Local scientific and ethical review structure outside the 
organization.
The research team will identify and recruit potential subjects in the 
Nee lab or Hajcak lab in the Psychology Building at Florida State 
University. Consent and fMRI screening will occur in the Nee lab 
or Hajcak lab in the Psychology building at Florida State 
University. The research procedures will be performed in the 
College of Medicine at Florida State University. This is where the 
MRI scanner is housed. There will be no composition and 
involvement of any community advisory board.
25.0
Resources Available
25.1 Describe the resources available to conduct the research: For 
example, as appropriate:

Justify the feasibility of recruiting the required number of 
suitable subjects within the agreed recruitment period. For 
example, how many potential subjects do you have access to? 
What percentage of those potential subjects do you need to 
recruit?
Many students of Florida State University and community 
members of the Tallahassee area will be eligible for our 
studies. This is a large pool from which to draw which will 
ensure the ability to recruit and test the required number of 
participants.
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
Describe the time that you will devote to conducting and 
completing the research.
The research will be conducted over the next several years

Describe your facilities.
The Nee lab and Hajcak lab are equipped with testing rooms 
with computers designated for testing subjects and privacy for 
consenting and screening participants. The College of 
Medicine houses the MRI scanner eye tracker, TMS, and EEG 
equipment where participants will perform experiments.

Describe the availability of medical or psychological resources 
that subjects might need as a result of an anticipated 
consequences of the human research.
A first aid kit is available at the TMS suite Emergent medical 
care is available through standard sources (e.g. 911).

Describe your process to ensure that all persons assisting with 
the research are adequately informed about the protocol, the 
research procedures, and their duties and functions.
All persons assisting with the research are adequately informed 
about the protocol, the research procedures, and their duties 
and functions by completing the Human Subjects Research 
training offered by CITI and shadowing trained researchers.
26.0
Multi-Site Research*
26.1
Study-Wide Number of Subjects*
If this is a multicenter study, indicate the total number of subjects to be 
accrued across all sites.
NA
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