Neural Basis of Sensory and Motor Learning: Functional Connections
Phase: NA
Conditions: Basic Science
Sponsor: Indiana University

Neural Basis of Sensory and Motor Learning: Functional Connections 
NCT05124301 
Study Protocol 
June 18, 2024 

Research Design 
 
Study purpose 
When interacting with objects in the environment, the brain routinely adapts perceptual and 
movement planning processes to compensate for changes in the environment. The neural basis is 
poorly understood, even in the healthy brain. The purpose of this study is to assess changes in 
resting state connectivity that accompany multisensory perceptual learning.  
 
Scientific background 
Human perception of hand position is multisensory. The brain can estimate it visually, from an 
image on the retina, and proprioceptively, from receptors in the joints and muscles. The sensory 
inputs determining these percepts are subject to changes in environmental factors (e.g., lighting) 
and internal factors (e.g., movement history). Multisensory integration of visual and proprioceptive 
estimates gives us flexibility to cope with such changes. For example, washing dishes with the 
hands immersed in water creates a spatial misalignment between vision and proprioception, as 
water refracts light. The brain resolves this conflict by realigning visual and/or proprioceptive 
estimates of hand position. The neural basis of these adaptive processes is poorly understood. The 
purpose of this study is to find out if multisensory changes are accompanied by changes in resting 
state connectivity between sensory regions of the brain and other areas.  
 
Describe the research interactions or interventions and data collection methods for the 
study. Include the frequency and duration of each procedure or activity. 
The study takes place in the Imaging Research Facility (IRF) in the psychology building. The first 
session is a familiarization session for functional magnetic resonance imaging (fMRI) and the 
behavioral task, and is expected to last 40-60 minutes. Subjects will first fill out screening forms to 
confirm the answers they gave during the initial screening, and the Edinburgh handedness 
inventory to quantify their handedness. If subjects are still eligible, they will lie in a mock scanner 
and perform the functional task: Subjects will have their left index finger taped to a wooden stick, 
and an experimenter from the team will manipulate the finger with the stick outside of the scanner. 
Subjects will respond to the different movements by pressing buttons with their right hand. 
Subjects will also be introduced to the behavioral task, which is performed at an apparatus in the 
room next to the scanner: Subjects sit in front of a touchscreen and point to targets they see in a 
mirror. If subjects are interested in moving on to the main session at this point, the main session 
will be scheduled. In the Main session, subjects will first fill out the MR safety screening form. They 
will then perform some practice trials of the behavioral task to remind the subject of the task. This 
will be followed by a short DWI scan (3 minutes), the first resting state scan of the baseline 
condition (12 min), the 20-30 minute baseline block of the behavioral task (control, no learning), a 
second resting state scan (12 min), a second 20-30 minute learning block of the behavioral task 
(Visuo-proprioceptive realignment, perceptual learning), and a third resting state scan (12 min). 
Finally, the subject will do the functional task in the scanner (same as familiarization session, 12 
min. total), an anatomical scan (~6 minutes), and a final DWI scan (3 minutes). The session will 
conclude with some questions about the subject’s subjective experience of the procedures. 
Including transition time in and out of the scanner, the Main session is expected to take up to 2.5 
hours. 
 
Will ongoing safety review be conducted by an independent group of individuals often called 
a data safety monitoring board (DSMB) or committee (DSMC/DMC)? 
No 

 
Describe the plan for conducting ongoing review of study-wide data to ensure the safety of 
subjects. Consider the following: 
• 
Who will review data 
• 
What data will be reviewed, at minimum adverse event data 
• 
How often data will be reviewed. 
The PI will be responsible for data and safety monitoring. The familiarization session is intended to 
weed out any subjects who might find laying in the scanner uncomfortable, but it is possible 
subjects who find the procedures acceptable during the familiarization will change their mind 
during the main session and withdraw before completing the session. If so, we would report this in 
annual reviews. The study team will meet at least monthly to review the study data, determine 
whether any events need to be reported, and discuss whether the familiarization session is 
sufficiently familiarizing subjects, or whether any additional risks can be identified. 
 
Research Settings 
 
Select all of the settings where the research interactions or interventions will take place. 
IU campus 
 
Confidentiality & Privacy 
 
Describe the procedures that will be used to ensure confidentiality of written/paper records 
that contain subjects’ identifiable data. 
Printed identifying information consists of the signed consent form and screening forms. The MR 
safety screening forms will be kept in locked cabinets in the IRF. The rest will be kept in the 
subject's folder in a locked file cabinet in our lab (PH 079), which is also locked when we're not in 
there. 
 
Describe the setting where research procedures will occur and how that protects subjects’ 
privacy. Consider recruitment, consent, and study interventions. 
Directions will be given to the subject in order for them to find the IRF, where all research 
procedures except initial screening will take place. Initial screening will be done by e-mail or over 
the phone, at the subject's choosing, using a standardized list of questions. Informed Consent will 
be obtained upon the first visit to the IRF prior to any study procedures taking place. Once the 
subject arrives in the IRF, doors will be closed and only study personnel will have access to the 
subject. 
 
Eligibility and Recruitment 
 
List the criteria that would make people eligible to be included in this study. 
Potential subjects must be between the ages of 18-45 years old and right-handed. Aging has been 
shown to affect the morphology of sensory and motor nerves, conduction velocities of nerves, and 
number of motor neurons in the spinal cord; to avoid these confounding factors we will only 
examine younger-to middle-aged adults. There are differences in cortical function and 
corticospinal projections such that testing the right arm of a right-handed individual is not 

necessarily equivalent to testing the left arm of a left-handed individual. To eliminate this 
confound, we will only test right-handed individuals. Covid has been found to have neurological 
effects in some people, but mostly the effects on sensorimotor control and neurophysiology are 
unknown. So we want to reduce the chances of inadvertently testing subjects who have covid. We 
will therefore only include individuals who report being free of Covid symptoms in week preceding 
testing.  
 
List the criteria that would exclude people from this study. 
Participants will fill out two screening forms: (1) At the familiarization session, they will fill out the 
in-person screening form to confirm the information they gave by e-mail or phone. The 
experimenter will make a preliminary eligibility determination based on this information. (2) At the 
main session, the subject will fill out the IRF's standard MR safety screening form, and a level 2 MR 
personnel will make the final eligibility determination. Both forms are included with this 
submission. The IRF technician will exclude subjects who have metallic, mechanical, or magnetic 
implants; are claustrophobic, or are unable to remain still for long periods of time; or use an intra-
uterine device (IUD) whos MR compatibility has not been established. Women who are pregnant or 
think they might be pregnant will also be excluded, as effects of fMRI on the unborn are not known. 
People who have a BMI over 30 will be excluded as it may be uncomfortable or impossible to lay in 
the MRI scanner and reach the button box. Potential subjects will be excluded if they have any 
neurological disorders, or orthopedic or pain conditions in the upper limbs. We will also exclude 
subjects who do not have normal vision, or corrected-to-normal vision with contacts, or the 
imaging center does not have a pair of MRI compatible glasses that fits their prescription. In 
addition, we will invite subjects to reschedule if they have any of the common Covid symptoms 
within the last week. If they don't believe they can meet these criteria on another date, they will be 
excluded. After giving their consent, participants may be excluded during the study if they are 
unable to perform the tasks or follow instructions.  
 
Will subjects be offered any of the following for their participation in the study? All of these 
are forms of payment. Select all that apply.  
Cash, gift card, or check 
 
Explain why the amount offered is reasonable in relation to the subjects’ involvement in the 
study. 
Subjects will receive a gift card after completing the main experimental session. The value will 
depend on the time spent: $10/hour for the familiarization session, $25/hour for the main session. 
Subjects who came to at least the familiarization session but were then excluded for one of the 
reasons above will receive partial payment. This is consistent with rate of pay for similar studies at 
IU. 
 
Describe your recruitment process, including how subjects will be identified and contacted.  
Main experiment: Potential subjects will initiate contact with the research staff in response to the 
recruitment flyers that will be electronically distributed in IU e-mail lists or electronically posted on 
the IU Classifieds site, or posted in appropriate physical locations around campus. The flyers invite 
potential participants to either visit a Qualtrics survey to receive information about the study and 
answer the eligibility questions, or else to e-mail the lab. If the inquiry is made by e-mail, the 
investigator will respond with the "Initial E-mail and Screening" message, which is included in this 
submission. It provides the same information and directs the person to the Qualtrics survey to 
determine eligibility. If they are interested in participating and meet the inclusion/exclusion criteria, 

then the experimenter will send the "Follow-up to eligible subjects" message to schedule the 
familiarization session and remind them of the elements that may affect their choice of when to 
schedule.  
 
Will any information be kept about individuals who decline participation or are found to be 
ineligible? 
No 
 
If a subject participates in this study, would it stop or prevent them from participating in 
another study? 
No 
 
Consent/Assent/Authorization 
 
Will all or some subjects consent to participate in the research? 
All subjects will consent to participate in the research. 
 
Does your study require any research procedures to occur prior to discussing study 
participation with subjects? 
No 
 
Describe your typical consent process for this study. 
After a subject has contacted us, had the study explained, and answered the screening questions, 
but prior to doing anything else related to the study, a time will be arranged for the familiarization 
session. The principal investigator or other key personnel will explain the study again in person and 
the subject will complete in-person screening form ("first visit" version) to ensure the information 
obtained during the initial screening has not changed. Then the consent process will begin. No one 
will be in the room with the subject except the investigator(s). The experimenter will review each 
section of the ICS with the subject in person, in the IRF, at the beginning of the first session. The 
subject will then have time to read the informed consent to themselves. The investigator will wait 
till the subject finishes reading, and then ask if they have any questions before inviting them to sign 
the ICS. This process will last about 15 minutes and will take place in the IRF with the doors closed.  
 
Describe how you will protect against, or minimize, each of the risks listed in the consent 
document(s). 
The only potential risk connected to the reaching task is fatigue or boredom. Subjects will be told to 
go at their own pace and ask for a break if they need it. MRI 1) This MRI scan is not a medical test. It 
is designed to address research questions and it is not a complete scan for any clinical purpose. If 
there is an abnormality, the scan, the MRI technician, or the researcher may not detect it. If the 
technician or researcher suspects a possible abnormality, the scan will be sent without any 
participant identifiers to a neuroradiologist for further review. If the neuroradiologist recommends 
further action, the subject will be notified. 2) Because of the strong magnetic fields used for MR 
imagers, persons who have magnetic life-support devices (e.g., pacemakers and aneurysm clips), 
metal prostheses or other metallic objects (e.g. cochlear implants, steel pins implanted to help 
repair and strengthen broken bones, metal fragments from previous injuries) cannot participate in 
this research. Anyone who does not pass the MRI screening checklist will not be permitted to 
participate in the study. 3)The MRI environment may be confining to some individuals 
(claustrophobia). Anyone who wants to be removed from the MRI will be removed immediately. 

4)There is potential risk of loss of confidentiality. The potential risk of loss of confidentiality will be 
minimized, as outlined below. 5)During MRI imaging it can be loud. Noise levels are below FDA 
limits and ear protection is provided to further reduce noise. 6)In extremely rare cases (about one 
in a million), the radiofrequency energy used in MRI has produced burns (most of them minor). It is 
indicated in the consent form for participants to inform staff immediately if they feel any type of 
burning sensation. They would be removed immediately. 7) Having to stay still during MRI scan may 
be uncomfortable. The magnet bed will be equipped with extensive padding. 8) Risks of MRI scans 
to pregnant women are not known. Pregnant or possibly pregnant women will not be permitted to 
participate in this study. 9) Some people may be uncomfortable filling out the MRI screening form 
because there are questions about tattoos, piercings, and birth control methods. Only the MRI 
technician goes over the MRI screening form with the subject and the forms are kept in a secure 
location. 10) While there is no evidence of increased risk with multiple scans, the risks associated 
with multiple scans are not known. The IUB imaging center is adopting an arbitrary maximum of 40 
hours of scanning time per individual per year and the time involved in the present study is well 
below that limit. Confidentiality The risk of loss of confidentiality will be minimized by storing 
identifying information only in two places, both secured to the best of our ability: (1) Printed 
identifying information consists of the signed consent form and screening forms. The MR safety 
screening forms will be kept in locked cabinets in the IRF. The rest will be kept in the subject's 
folder in a locked file cabinet in our lab (PH 079), which is also locked when we're not in there. (2) 
Electronic identifying information exists in a password-protected spreadsheet of subject names 
and contact information, with the numerical code that will be associated with the experimental 
data. The spreadsheet is kept on a secure network drive on the IU Teams server, accessible only to 
the investigators. If subjects respond to the initial screening questions over e-mail, we will delete 
this e-mail after determining eligibility. The text of the initial screening e-mail tells the subject we 
are happy to ask the screening questions by phone, so they know they have the option of not writing 
personal information in an e-mail. All the information we ask in the initial screening is replicated on 
the in-person screening form, which subjects fill out when they come to the lab, and this form is 
used to officially determine eligibility, so there is no need to retain the initial e-mail. To protect the 
subject's confidentiality, we will only e-mail the subject from an IU e-mail account (ending in 
indiana.edu or iu.edu). There will be no other electronic or paper identifying information, as all 
experimental data we collect (through software or a paper data sheet during the experiment) will 
only have the numerical code assigned to the subject.  
 
For those subjects who will consent to participate, choose whether the consent and 
authorization process will be documented by a signature from subjects. 
All consented subjects will provide a signature as documentation of consent and, if applicable, 
authorization. 
 
Will subjects participate in any study activity prior to signing a consent document? 
No 
 
Statistical analysis plan 
Primary outcome variables include resting state functional connectivity between each unique pair 
of ROIs and weighting of vision vs. proprioception. Multiple regression will determine whether 
functional connectivity is related to participants’ weighting. Priority ROIs are ventral premotor 
cortex (PMv) and primary motor cortex (M1).