Evaluating the Neurocomputational Mechanisms of Explore-Exploit Decision Making in Older Adults
Phase: NA
Conditions: Healthy Aging
Sponsor: University of Arizona

Official title: Evaluating the Neurocomputational Mechanisms of Explore-Exploit Decision 
Making in Older Adults 
NCT number: NCT05178381 
document date: 9/13/23 

 
 
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HSPP Use Only: Consent Form  
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University of Arizona  
Consent to Participate in Research 
Study Title: The explore-exploit dilemma in human decision making: behavioral 
and pupillometric, electroencephalographic, fMRI and TMS experiments 
Principal Investigator: Robert Wilson 
Sponsor: Robert Wilson, NIH 
 
Summary of the research 
This is a consent form for participation in a research project. Your participation in this research 
study is voluntary. It contains important information about this study and what to expect if you 
decide to participate.  Please consider the information carefully. Feel free to ask questions 
before making your decision whether to participate. 
The goal of this study is to investigate how people tradeoff information and reward when 
making decisions and how this decision-making process changes with age. If you take part in 
this study, you will come to the lab for either two or five experimental sessions, depending on 
your eligibility.  
 
Sessions 1 & 2: The first two sessions are behavioral sessions lasting 2-3 hours each. In these 
behavioral sessions you will complete a series of behavioral tests. Depending on your 
performance on these tests, you may be invited back to take part in the remaining three 
sessions.  
 
Session 3: The third sessions is an MRI session lasting approximately 2 hours. In this session we 
will image activity in your brain while you perform a decision-making task. 
 
Sessions 4 & 5: The final two sessions involve transcranial magnetic stimulation (TMS). This 
procedure involves stimulating your brain with an electromagnet for approximately 40 seconds. 
After stimulation is complete you will then perform a decision-making task. Each session will 
take up to 2 hours. 
 
The risks from taking part in this study are low and are outlined in detail further down this 
consent form. In brief: 
• There is no risk from the behavioral studies.  
• The risks from MRI involve the high magnetic field which can interact with metallic 
implants (e.g., pacemakers). Proper screening minimizes these risks. 
• The risks from TMS come from the stimulation of the brain. In theory, seizure is possible 
following TMS, but this is rare and has almost never occurred since stricter exclusion 
criteria were established. It is also possible to develop a headache after TMS, which can 
be treated with over-the-counter medications such as Advil. It is also possible to 

 
 
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experience lightheadedness if you are not properly fed and hydrated before taking part 
in the experiment. 
 
 
Why is this study being done? 
The purpose of this study is to learn how humans tradeoff information and reward when 
making decisions and how this decision-making process changes with age. 
 
What will happen if I take part in this study? 
Before the study begins, you will be asked to complete a short online questionnaire and 
telephone interview to assess your eligibility to participate. If you are eligible you will come into 
the lab for two sessions of initial testing on two different days. In the second session, you will 
also complete a short survey about any pain you may have experienced in the past 3 months. 
Depending on your performance and/or eligibility for magnetic resonance imaging and 
transcranial magnetic stimulation, you may be invited back for three more experimental 
sessions on different days. Thus, if you participate in this study, you will complete either the 
first two or all five of the following experimental sessions. 
 
Sessions 1 and 2 – Behavioral sessions. In sessions 1 and 2 you will come into the lab for 
approximately 3 hours of cognitive and behavioral testing each session. These tests involve 
completing tasks either verbally, on pen and paper, or on a computer. There is no risk 
associated with any of these tests. 
 
Depending on your performance on these initial behavioral tests we may invite you back to take 
part in the following three experimental sessions. 
 
Session 3 – MRI session. The scanning session will be very similar to a routine clinical MRI scan 
of the brain. You will be asked to lie down on a table. Foam pads will be placed around your 
head to limit head movement during the study. The table will then be slid into the magnet. 
While in the scanner, you will be asked to lie still for approximately one hour, during which time 
several scans will take place. At times, you will be asked to perform the experiment task. In 
general, it will require you to observe stimuli presented on a screen. You will be asked to 
observe and/or respond to these stimuli by pressing a button. The whole session will last 
approximately two hours, including about 30 minutes of preparation and about 90 minutes 
inside the scanner. Occasional breaks of 1 to 2 minutes will be provided, during which you will 
remain in the scanner. 
 
Sessions 4 & 5 – Transcranial Magnetic Stimulation (TMS) sessions. The TMS operator will first 
calibrate the TMS machine to establish an appropriate “dose” of stimulation. To do so, we will 
gently place the TMS coil on the surface of your head directly above the region of the brain that 
is responsible for hand motions. The TMS coil will then deliver single pulses that incrementally 
get stronger until a level is reached that causes your hand to twitch. The “strength of the dose” 
required to make your hand twitch is called the “motor threshold” and it varies for each 
individual. We will identify two separate motor thresholds; 1) Resting Motor Threshold 

 
 
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(acquired at rest), and 2) Active Motor Threshold (acquired while participant gently pinches 
their thumb and pointer finger together). These “motor threshold” measures will then be used 
to calibrate the machine for the TMS protocols. Importantly, in addition to observing your hand 
visually, we will also attach sensors to the skin on your hand. These sensors will detect any 
activity in your muscles, which will yield a more accurate measurement for your personal 
“motor thresholds”. 
 
During the TMS protocol, we will apply what is known as continuous theta burst stimulation for 
40 seconds at 80% AMT. After TMS is applied you will perform a behavioral task. 
 
How long will I be in the study? 
Each behavioral session lasts between 2 and 3 hours. The MRI session lasts approximately 2 
hours. The TMS sessions last up to 2 hours each.  
 
Thus, if you complete the two behavioral sessions you will be in the study for 4-6 hours across 
two sessions on different days. If you qualify for all five sessions of the study, you will be in the 
study for approximately 10-12 hours across five different days. 
 
How many people will take part in this study? 
Approximately 240 
 
Can I stop being in the study? 
Your participation is voluntary.  You do not need to participate in this study.  If you decide to 
take part in the study, you may leave the study at any time.  No matter what decision you 
make, there will be no penalty to you and you will not lose any of your usual benefits.  Your 
decision will not affect your future relationship with The University of Arizona.  If you are a 
student or employee at the University of Arizona, your decision will not affect your grades or 
employment status.  
 
What risks or benefits can I expect from being in the study? 
Behavioral sessions: There are no physical risks associated with the behavioral studies, which 
simply involve answering questions and making decisions.  
 
The cognitive task that we give you in the first session might reveal a low score. It is important 
to know that this cognitive test is not diagnostic. However, if you want to discuss your score, 
you can speak with Principal Investigator Dr. Robert Wilson. He can be reached at 
bob@email.arizona.edu or via the research assistant who is managing your enrollment in the 
study. If desired, you may wish to contact your primary care provider for more comprehensive 
testing. 
 
MRI session: The risks involved are minimal and are limited to the risks present during routine 
MRI examinations. When near an MRI scanner, there is a potential for the powerful magnetic 

 
 
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field to attract ferromagnetic metallic objects toward the magnet. For this reason, you will be 
carefully screened for previous exposure to metallic fragments or clips that may be inside your 
body. Similarly, you will be asked to place all metallic and magnetic objects in your possession 
(e.g. keys, credit cards) in a locker outside the magnet room. 
While you are lying in the scanner, you will often hear beeping and knocking noises, some of 
which may be loud, that are produced by the scanning equipment. Disposable earplugs will be 
provided to diminish the noise. 
You will always be able to communicate with the scanner operator throughout the study. 
Before and after individual scans, there will be breaks during which you will be able to talk with 
the operator through an intercom system. During a scan, the equipment noise will make it 
difficult to use this intercom, but you will also have at all times a signal ball that you can 
squeeze to let the operator know that you would like speak to them. If you ever squeeze this, 
the operator will immediately stop the scan, and you will be able to use the intercom once 
again. If at any time you feel uncomfortable or unwilling to continue, no matter what the 
reason, you can request to immediately stop the study, and the operator will remove you from 
the scanner. Because you will not be physically restrained in the scanner, you could even pull 
yourself out if necessary; however, we ask that you instead use the intercom or squeeze bulb to 
tell us to remove you. 
The bore of the magnet is a small space and some people may feel claustrophobic. Most 
participants rapidly grow accustomed to the space, but please let us know if you feel 
uncomfortable, and remember that you can always choose to leave the scanner at any time. 
Although there is no known or anticipated risk to a fetus, you will not be allowed to participate 
in the study if there is any possibility you are pregnant. Beyond the risks described above, there 
are no known long-term physical risks associated with fMRI studies. 
The head coil, which we will place around over your face when we put you in the scanner, uses 
pulses of radio waves to scan your brain. This is completely safe. However, if the head coil is 
touching your face it is possible that the heat of the coil may cause mild burns. There is no risk 
of burns if the head coil is not touching your face. When we place you in the scanner, we will 
make sure that your face is not touching the head coil. If, however, you move in the scanner 
and the head coil does touch your face please let us know immediately over the intercom or by 
using the squeeze bulb. 
If in the course of this research scanning protocol we observe an anomaly in one or more of the 
MRI images, you will be informed of the observation. An anomaly does not necessarily indicate 
the presence of any disorder. Because our MRI scans are for research purposes only, they may 
be inadequate for the purpose of clinical diagnosis. Additionally, as researchers, we are not 
trained to clinically interpret MRI data. However, we feel it is important to inform you of any 
observations, as we cannot rule out the possibility that this anomaly may require medical 
advice. All information collected as part of this study will be made available to you for further 
examination by a medical professional. If you prefer not to be informed of anomalous findings, 
you must choose not to participate in the study. 

 
 
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TMS sessions: Seizure is a theoretical risk with TMS. TMS procedures are associated with a very 
low risk of seizures. Out of over 10,000 people given various forms of TMS over the last two 
decades 16 people (~ 0.1%) have been reported to have had a seizure. Eight occurred before 
safety parameters were established in 1997. Of the other eight reports, six occurred either 
when the safe rTMS parameters were exceeded or other safety guidelines ignored, and the 
actual occurrence of a seizure has been questioned in the other two (i.e., convulsive syncope or 
pseudoseizure may have occurred). 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 
rTMS consensus safety guidelines, including recommended stimulation parameters and contra-
indications (Wasserman, 1998), and these consensus guidelines have been recently updated 
(Rossi et al., 2009). Widespread adherence to the 1996 guidelines has resulted in the virtual 
elimination of inadvertent seizures in rTMS studies (Rossi et al., 2009). 
This study will only use levels of TMS that are within current safety guidelines, which have been 
formulated after careful review of thousands of participants/patients receiving TMS. Levels of 
TMS that fall within the safety guidelines have not been associated with seizure in appropriately 
screened individuals. No seizures have occurred in normal volunteers with the dosage of TMS 
used in this study. To minimize this risk, you will be medically screened for any of the known 
characteristics that could lead to seizure. For example, persons with epilepsy cannot participate 
in this study. You will be visually monitored during the TMS for any signs of seizure or 
unexpected muscle twitching. 
In spite of these precautions, there is a chance that you will experience a seizure. Should this 
occur, emergency facilities are available. If you have a seizure, you may require hospital 
admission and follow-up neurological evaluation. Having had a convulsion may make it difficult 
for you to obtain medical insurance, future employment, and to drive. It is not known whether 
having had one convulsion will make a person more prone to have future seizures. Should you 
have a seizure caused by TMS in this protocol, we will provide you with a letter documenting 
that the seizure was experimentally induced. 
While only experienced by a minority of participants, the most commonly reported side effect 
of TMS is a "muscle-tension" type headache. If a headache occurs, it usually starts during or 
immediately after the TMS and lasts from minutes to hours after TMS. The headache usually 
goes away with standard over-the-counter pain medications (e.g., Advil). Neck or scalp pain 
may also occur. You may also experience some discomfort on your head where the coil is held. 
This is due to contraction of scalp muscles. Numbness of the face lasting for a short time has 
also been reported in rare instances that may last for several weeks after receiving the 
procedure. 
The click noises produced by the TMS procedure are loud enough to be damaging to your ears. 
You will therefore be required to wear earplugs, which will be provided by the experimenter to 
minimize this risk. 

 
 
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Additional side effects considered to be rare in TMS are dizziness, memory impairment, trouble 
concentrating, and acute mood changes. If these occur, these effects do not last long and 
should resolve without need for treatment. 
It is possible that if you are not properly fed and hydrated before taking part in the experiment 
that you may experience lightheadedness. If this occur, these effects do not last long and 
should resolve after eating food and drinking water, which we have available in the lab. 
 
There may be other risks that are currently unknown. There are no known long-term effects of 
TMS at this time. 
Data privacy: There is also a risk of potential loss of confidentiality. Every effort will be made to 
keep your information confidential; however, this cannot be guaranteed.  
Although we have tried to avoid risks, you may feel that some questions [or procedures] we ask 
you to do may be stressful or upsetting. If this occurs, you can stop participating immediately. 
 
You will not receive any benefit from taking part in this study. 
 
Will I be paid for participating in the study or experience any costs? 
You will be paid $20/hour for each session. Compensation for participation in a research study 
is considered taxable income for you. If your compensation for this research study or a 
combination of research studies is $600 or more in a calendar year (January to December), you 
will receive an IRS Form 1099 to report on your taxes.  Please note, if you are an employee of 
UArizona, any compensation from a research study is considerable taxable income. 
 
For any compensation or reimbursement you receive, we are required to obtain identifiable 
information such as your name, address, and Social Security number for financial compliance 
purposes. 
 
Will my study-related information be kept confidential? 
The information that you provide in the study will be handled confidentially. However, there 
may be circumstances where this information must be released or shared as required by law. In 
particular, your records may be reviewed by the following groups: 
• The University of Arizona Institutional Review Board or Office of Responsible Research 
Practices; 
• 
Other federal, state, or international regulatory agencies; 
• 
The sponsor of the study, if any, may review the research records for monitoring 
purposes 
 
Researchers will view your anonymous experimental data for coding and analytic purposes, but 
they won’t link the experimental data to your identity for any purposes. 
 

 
 
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This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information, documents, or 
samples that may identify you in any action or suit unless you say it is okay. They also cannot 
provide them as evidence unless you have agreed.  This protection includes federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings. An example would be a 
court subpoena. 
 
There are some important things that you need to know.  The Certificate DOES NOT stop 
reporting that federal, state or local laws require. Some examples are laws that require 
reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or 
others.  The Certificate CANNOT BE USED to stop a sponsoring United States federal or state 
government agency from checking records or evaluating programs. The Certificate DOES NOT 
stop disclosures required by the federal Food and Drug Administration (FDA).  The Certificate 
also DOES NOT prevent your information from being used for other research if allowed by 
federal regulations. 
 
Researchers may release information about you when you say it is okay. For example, you may 
give them permission to release information to insurers, medical providers or any other 
persons not connected with the research.  The Certificate of Confidentiality does not stop you 
from willingly releasing information about your involvement in this research. It also does not 
prevent you from having access to your own information.  
 
 
Will my study-related information be used for future research?  
Results will be kept to allow us to investigate new questions related to the purpose of this 
research. Once identifiers have been removed from your data, the information could be 
distributed to another investigator, or publicly archived, for future research. Re-consent will not 
be obtained from you if test records and results are used for future research. Consent forms will 
be stored in the Psychology Building for six years.  
 
There may be an opportunity to participate in other research conducted by our and/or our 
collaborator’s group. In some studies, invitation for other studies may depend on scores in 
neuropsychological testing.  
 
Please check this box if you want to be contacted to participate in future research conducted 
by our or our collaborator’s team. 
      Please check this box if you do NOT want to be contacted to participate in future research. 
Who can answer my questions about the study? 
For questions, concerns, or complaints about the study you may contact Robert Wilson at 
bob@email.arizona.edu. 
 
For questions about your rights as a participant in this study or to discuss other study-related 
concerns or complaints with someone who is not part of the research team, you may contact 

 
 
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the Human Subjects Protection Program Director at 520-626-8630 or online at 
https://research.arizona.edu/compliance/human-subjects-protection-program. 
 
If you are injured as a result of participating in this study or for questions about a study-related 
injury, you may contact Robert Wilson at bob@email.arizona.edu. 
 
Signing the consent form 
I have read (or someone has read to me) this form, and I am aware that I am being asked to 
participate in a research study.  I have had the opportunity to ask questions and have had them 
answered to my satisfaction.  I voluntarily agree to participate in this study.  
 
I am not giving up any legal rights by signing this form.  I will be given a copy of this form. 
 
 
 
 
 
 
Printed name of subject 
 
Signature of subject 
 
Date