Efficacy of Non-Invasive Brain Stimulation on Dual-Task Walking After Stroke: A Repetitive Transcranial Magnetic Stimulation (rTMS) Study
Phase: NA
Conditions: Stroke
Sponsor: Texas Woman's University

If applicable, agency approval letters must be submitted to the IRB upon receipt prior to any data 
collection at that agency.  A copy of the approved consent form with the IRB approval stamp is 
enclosed. Please use the consent form with the most recent approval date stamp when obtaining 
consent from your participants. A copy of the signed consent forms must be submitted with the 
request to close the study file at the completion of the study. 
Any modifications to this study must be submitted for review to the IRB using the Modification 
Request Form. Additionally, the IRB must be notified immediately of any adverse events or 
unanticipated problems. All forms are located on the IRB website. If you have any questions, please 
contact the TWU IRB.
The above referenced study has been reviewed and approved by the Dallas IRB (operating under 
FWA00000178)  on 10/18/2016 using an expedited review procedure. This approval is valid for one 
year and expires on 10/18/2017. The IRB will send an email notification 45 days prior to the 
expiration date with instructions to extend or close the study. It is your responsibility to request an 
extension for the study if it is not yet complete, to close the protocol file when the study is complete, 
and to make certain that the study is not conducted beyond the expiration date.
Approval for Efficacy of Non-Invasive Brain Stimulation on Dual-Task Walking After Stroke: A 
rTMS Study (Protocol #: 19219)
Re:
Institutional Review Board
Office of Research and Sponsored Programs
P.O. Box 425619, Denton, TX 76204-5619
940-898-3378
email: IRB@twu.edu
http://www.twu.edu/irb.html
October 19, 2016
Physical Therapy - Dallas
Dr. Hui-Ting Goh
Institutional Review Board (IRB) - Dallas
DATE:
TO:
FROM:
Dr. Mary Thompson, Physical Therapy - Dallas
cc.

June 2015 (revised Nov 2015) 
 
1 
Texas Woman's University Institutional Review Board 
 
Application for Expedited and Full Review 
 
 
Name of Principal Investigator (PI): 
Hui-Ting Goh, PhD 
Phone: 
214-689-7723 
Status:  
 faculty  
 student  
 staff  
 other :       
E-mail: 
hgoh1@twu.edu 
Department: 
School of Physical Therapy  
Colleague ID# (this is the 7-digit # on your ID):  
0598520  
Title of Study: Efficacy of non-invasive brain stimulation on dual-task walking after stroke: a rTMS study 
If the PI is a student, provide the following information for the faculty advisor: 
Name of advisor: 
      
E-mail: 
      
 
TWU Department: 
      
 
 
Estimated beginning date of study: 
10/1/2016 
Estimated duration of study 
2 years 
Campus (Denton, Dallas, or Houston) 
Dallas 
Level of review:  
 expedited 
 full 
Type of Project : 
 thesis 
 professional paper  
 dissertation  
 class project 
(check all that apply) 
 faculty research 
 pilot 
 other          
Has project has been submitted for funding (internal or external)?  
 yes 
 no    
          If yes, funding source:        
 
Signatures: 
 
Principal Investigator (PI): Signature certifies that the investigator has primary responsibility for all aspects of the 
research project. 
____________________________________________________________ 
 
________________ 
Principal Investigator 
 
     Date 
 
Faculty Research Advisor (for student research only): Signature certifies that the faculty member has read, 
reviewed, and approved the content of the application and is responsible for the supervision of this research study.   
____________________________________________________________ 
 
________________ 
Faculty Research Advisor  
 
     Date 
 
Academic Administrator: Signature certifies that the administrator has read, reviewed, and approved the content of the 
application.  
____________________________________________________________ 
 
________________ 
Academic Administrator (Department Chair, Program Director, or Associate Dean) 
 
     Date 
For office use only: 
 
Protocol #: __________ 

June 2015 (revised Nov 2015) 
 
2 
METHODOLOGY 
 
Please refer to instructions when completing this form. The application must be typed using a font 
no smaller than 11-point. 
 
1. Describe the purpose of study, including research questions and/or hypotheses. 
 
 
Purpose: The purpose of this pilot study is to examine the feasibility and efficacy of a non-
invasive brain stimulation technique, repetitive transcranial magnetic stimulation (rTMS) in 
dual-task walking in individuals post-stroke. Our long-term objective is to use the technique as 
an adjunct rehabilitative tool to enhance gait recovery after stroke.  
 
 
Background: Control of human movements requires sophisticated coordination between 
motor system and cognitive system. In able-bodied, the interaction between the two systems 
is often faultless and allows automatic execution of well-learned motor skills, such as walking. 
However, such coordinated interaction is often disrupted after brain insults (e.g. stroke). 
Numerous studies have shown that patients with stroke have difficulty in dual-task 
performance, for instance talking while walking1-4. Therefore, dual-tasking has been deemed 
as an important outcome to determine the effectiveness of gait rehabilitation5. To date, there is 
very limited research on how to enhance dual-task gait in stroke6-9.  
 
 
 
Non-invasive brain stimulation, such as rTMS, has been found to be an effective adjunct 
tool to traditional behavioral training to improve recovery of arm-hand function after stroke10. 
rTMS can be used to up-regulate or down-regulate the excitability of the targeted neural 
network and subsequently affect the behaviors supported by that neural network. For 
example, in a previous research we applied 5Hz rTMS on the primary motor cortex (M1) in 
young healthy adults and found that it significantly increased M1 excitability11. Similarly, we 
demonstrated that application of 1Hz rTMS on the dorsal premotor cortex (dPM) significantly 
decreased corticospinal excitability and interfered with participant’s ability to learn the motor 
task under dual-task conditions12. Although the efficacy of rTMS has been well-demonstrated 
in recovery of upper extremity motor function after stroke, its usefulness for gait recovery is 
understudied13,14.  
 
 
 
There have been attempts to use non-invasive brain stimulation to improve dual-task 
walking in humans15-17, including neurological involved population17,18. To date, there is no 
study that examines the efficacy of non-invasive brain stimulation in dual-task walking in 
individuals post-stroke. In addition, previous research has primarily focused on stimulating left 
dorsal lateral prefrontal cortex (DLPFC). Most studies found that up-regulating excitability of 
the left DLPFC improved dual-task cost but had little effect on gait performance18. One 
possible explanation is that the DLPFC does not play an important role in governing gait 
performance during dual-tasking even though it has significant impact on task switching19. 
Therefore, other neural networks, such as the supplementary motor area (SMA) that has been 
found to be associated with gait recovery15,20-22 may also play an important role in modulating 
dual-task gait. The purpose of this pilot project is to examine the efficacy of rTMS applied to 
different neural loci in improving dual-task gait in individuals post-stroke.  
 
Research question: Would rTMS applied to different neural loci result in different dual-task 
gait performance in patients with stroke? 
 
 
 
 

June 2015 (revised Nov 2015) 
 
3 
2. Participant Information: 
 
 
a. 
Description of participants in study:    
 
Ten men and women with a diagnosis of left hemisphere stroke and age >18 years will be 
recruited to participate in this pilot project.  
 
 
b. 
Approximate number of participants:   10 
 
 
c. 
Vulnerable populations as participants (check all that apply): 
 
 
 
Prisoners ................................................. 
 
 
 
Pregnant women..................................... 
 
 
 
Fetuses / neonates ................................. 
 
 
 
Minors ..................................................... 
 
 
 
 
NOTE: Researchers must comply with the federal mandate to report child abuse. See instructions for 
details.  
 
 
d. 
Age (or age range) of participants: > 18 years 
 
 
 
Provide the rationale for inclusion/exclusion on the basis of age:  
1. This study will not include individuals age below 18 years for a few reasons. Stroke is relatively 
uncommon in persons younger than 18 years. Further, rTMS safety data in children and 
adolescents are less well-established. We exclude individuals younger than 18 years for both 
scientific merit and safety concern.   
 
 
e. 
Sex of participants .................................................................................. 
Male 
 Female 
 Both  
 
 
 
 
Provide the rationale for inclusion/exclusion on the basis of sex:  
 
      
 
 
f. 
Participants will be excluded based on ethnicity: .............................................................. 
Yes 
 No 
 
 
 
If yes, provide a description of the exclusion criteria and the rationale for using these criteria: 
 
      
 
 
 
g. 
List and provide rationale for any other inclusion/exclusion criteria:  
 
Inclusion criteria: 
1. Age above 18 years  
2.Stroke is very unlikely in individuals age below 18 years. Further, there are limited 
data to support the safety of rTMS in individuals younger than 18 years.  
 
2. Diagnosis of Left hemispheric stroke at least 6 months ago 
2.Left dorsolateral prefrontal cortex has been shown to play an important role in human 
dual-task performance. We therefore specifically target those with left hemispheric 
lesion since they demonstrate greater deficits in dual-tasking. We exclude acute and 
subacute (< 6 months) stroke because spontaneous recovery is very likely to occur 

June 2015 (revised Nov 2015) 
 
4 
during acute and subacute phases. This will lead to difficulty in result interpretation with 
the current single group design.   
 
3. First time stroke OR complete gait recovery from prior stroke 
2. Individuals with more than one stroke often have more than one lesion location or 
involve more than one hemisphere. This would potentially complicate the rTMS 
application. We therefore exclude those with multiple strokes such that our sample can 
be more homogenous.  
 
4. Able to walk independently for at least 10 meters with or without walking aids 
2.Participants are required to walk independently for the behavioral testing.  
 
5. Have at least minimal movements (> 5 degree of motion) at the affected ankle 
2.Stroke survivors with big lesions at the motor areas often have difficulty to actively 
control distal segments (hands or ankle) and show very little responses to TMS 
stimulation. In our past experience, we found that resting motor threshold cannot be 
reliably measured in those with very little active movements. 
 
6. Score > 26 on Mini Mental State Exam (MMSE) 
2.Participants are required to score > 26 to rule out any cognitive impairments that 
would interfere with their comprehension of instructions.  
 
7. Ability to participate in the informed consent process 
 
Exclusion criteria: 
1. Diagnosis of other neurological conditions, such as Parkinson Disease, Alzheimer, 
Spinal Cord Injury, Multiple Sclerosis  
2.This is to ensure that our sample is representative of stroke.  
 
2. Other comorbidities which could interfere with gait (i.e. amputation, severe 
osteoarthritis) 
2.This is to ensure that any potential gait deviations observed can only be attributed to 
stroke. 
  
3. Unstable clinical conditions 
2.This is to ensure safety during testing. Individuals with unstable clinical conditions, 
eg. uncontrolled hypertension, will not be included.  
 
4. Non-ambulatory prior to onset of stroke 
2.This is to ensure that any potential gait deviations observed can only be attributed to 
stroke. 
 
5. History of significant head trauma 
2.This is a contraindication of high frequency rTMS.  
 
6. Electrical, magnetic, or mechanical implantation: cardiac pacemakers or intracerebral 
vascular clip 
2.This is a contraindication of TMS.  
 
7. Metal implantation in the oral cavity, head/neck area and lower extremity 
2.This is a contraindication of TMS.  

June 2015 (revised Nov 2015) 
 
5 
 
8. Pregnancy 
2.This is a contraindication of TMS.  
 
9. History of seizures or unexplained loss of consciousness 
2.This is a contraindication of TMS.  
 
10. Immediate family member with epilepsy 
2.This is a contraindication of TMS.  
 
11. Use of seizure threshold lowering medicine 
2.This is a contraindication of TMS.  
 
12. Current abuse of alcohol or drugs 
2.This is a contraindication of TMS.  
 
13. Anticipated inability to complete the study 
2.This is to ensure that participants can complete the study (all 3 visits).  
 
14. History of psychiatric illness requiring medication control  
 
2.This is a contraindication of TMS.  
 
 
 
 
3. Describe the participant recruitment process in detail. Make sure that you attach any 
recruitment materials or scripts in the attachment section. 
 
 
 
Research participants will be recruited through local advertising and word-of-mouth by PI 
and research assistants (advertising flyer attached). The potential participants will contact 
the PI or research assistants via email, phone or face-to-face for a short meeting within 
which the research project will be explained by the PI or the research assistants using the 
Consent Form as a guide. This meeting will take approximately 10-15 minutes. It should be 
noted that if the participant indicates he/she does not wish to participate after the meeting, 
he/she would not be enrolled. The signed consent will be obtained upon the agreement to 
participate. The original consent will be kept in the research file, one copy will be placed with 
the PI and the participant will receive a copy. 
 
 
4. Research Procedures: 
 
a. In the space below, describe in detail the research procedures (do not use an attachment): 
 
 
 
1. Screening and Baseline assessment: Upon the consent, participants will be 
screened for their eligibilty in addition to the criteria. We will use  Mini Mental State 
Exam (MMSE; 3.Appendix 1) and TMS safety-screening questionnaire (3.Appendix 2) 
to ensure that participants do not have any cognitive impairments or contraindications 
for TMS. In addition, they will be asked to perform a 10 meter walk test to ensure they 
are able to walk 10m independently.  
 

June 2015 (revised Nov 2015) 
 
6 
Once the eligibility is determined, each participant will be assessed with the Fugl-
Meyer Motor Assessement (FMA; 3.Appendix 3)23 scale to quantify their motor 
impairment and a Trail-Making Test (TMT; 3.Appendix 4)24 to assess their executive 
function.  
  
2. Assessements: Each participant will be tested with a gait assessment, followed by a 
counting task performance and a neurophysiological assessement.  
 
 2a. Gait Assessment: The gait assessment consists of walking at self-selected speed 
on the GaitRite carpet walkway. Gait performance (time taken, gait speed, stride 
cycle, step length) will be recorded by the GaitRite. The assessment will be repeated 3 
times with about a 1 minute break between trials.   
 
The walking test will then be repeated for another 3 trials under a dual-task condition 
in which the participants will perform the walking task in conjunction with a counting 
task. Before the ‘Go’ command, the tester will verbally provide a random number 
ranged from 30 to 100. They are then asked to perform the TUG test and count 
backward by 3 from the given number (e.g. 87, 84, 81, …). During the dual-task TUG 
test, the participants will be asked to priortize the counting task.  
  
       In addition to the GaitRite measurement, the gait assessment will be video-
recorded such that participants’ performance on the counting task can be quantified 
offline (number of correct responses).  
 
  
2b.Counting Task assessment: After the participants finish the gait assessment, the 
counting task will be repeated 3 times while they are seated.  
 
  
2c. Corticospinal excitability assessment: After the 
counting task assessment, participants will go through a 
series of corticospinal excitability assessement using 
single pulse transcranial magnetic stimulation (TMS, 
MagstimR  Company, UK) . Surface electromyography 
(EMG) electrodes will be placed on the right Tibilias 
Anterior muscle with the participants seated on a reclining 
chair and wearing a pair of earplugs. EMG data will be 
sampled at 2000Hz and band-pass-filtered at 15-500Hz 
(Mega 600, Mega Electronics Ltd, Finland). The EMG data 
will be recorded and stored  using MegaWin software 
(Mega Electronics Ltd, Finland) and analyzed offline using 
Matlab program (The Mathowroks, Inc, Natick MA). A 
Magstim 200 stimulator (Magstim Company, UK) will be 
used to deliver the TMS pulse via a double cone coil (Figure 1).  
Figure 1. Double cone coil.  
 
Neuronavigation system Brainsight TM (Rogue Research, Canada) will be used to 
reliably place the TMS coil over the scalp to precisely target the selected area. 
Stimulation will begin at 40% of maximum stimulator output and will be systematically 
increased to yield a motor evoked potential (MEP) from the tibialis anterior. A ‘hot 
spot’of the right tibialis anterior will first to be determined. Hot spot is defined as the 
site at which the largest MEP is obtained at the lowest TMS stimulation intensity. Once 
the hot spot is determined, the resting motor thershold (RMT) will be defined. Resting 
motor threshold is the stimulation intenisty that yield a MEP peak-to-peak amplitude > 
50 μV in 5 out of 10 consecutive trials. Once RMT is decided, the stimulation intensity 

June 2015 (revised Nov 2015) 
 
7 
will be set at 120% RMT  and 10 stimulations will be delivered to the hot-spot such 
that suprathreshold MEP can be recorded. These MEPs measures will be stored and 
analyzed offline to quantify corticospinal excitability.  
 
 
3. rTMS protocols: After the corticospinal excitability assessment, participants will 
receive a high frequency rTMS applied to different areas 
at different visits.  
During each visit, they will receive 5Hz rTMS delivered to 
the target area (hot spot of the right tibialis anterior at the 
M1, left SMA, or left DLPFC). The 5Hz rTMS will be 
delivered in the form of 24 10-second trains with a 30-
second intertrain interval (a total of 1200 pulses) via a air-
filled figure of 8 coil (Figure 2). The stimulation intensity 
will be set at 90% of individual RMT. We have previously 
shown that this protocol was effective to upregulate 
corticospinal excitability11.  
 
 
 
 
 
 
Figure 2. Air-filled coil for rTMS 
 
 
 
 
After the rTMS protocol, corticospinal excitability will be reassessed using single pulse 
TMS again (procedure 2c). Participants will then perform the gait assessment 
(procedure 2a) and the counting task (procedure 2b).  
Each participant will be tested for 3 visits (each visit will be 7±2days apart between two 
successive visits). Each visit will start with the assessment and be followed by a rTMS 
protocol. The target area for the rTMS protocols varies across visits (e.g. visit 1: Left 
SMA, visit 2: Left M1, and visit 3: Left DLPFC). The order will be pseudo-randomized 
and counterbalanced within each group.  
 
 
 
4. Outcomes and data analysis: The primary outcome of this project is participant 
performance on the TUG test under single and dual-task conditions. The time taken to 
complete the TUG test under the two conditions will be used to derive dual-task cost 
(TUGdual – TUGsingle/TUGsingle). The dual-task cost will be compared across three rTMS 
protocols using repeated measure ANOVA.  
The secondary outcomes of the projects include gait parameters obtained from the 
GaitRite, MEPs measured under procedure 2c. These measures will be analyzed 
using repeated measure ANOVA as well.  
 
 
b. Is video recording a part of the study? 
 
Yes 
 No 
 
 
              With sound  
 
Without sound  
  
 
c. Is audio recording a part of the study?.............. ............................................................... 
Yes 
 No 
 

June 2015 (revised Nov 2015) 
 
8 
  
If you answered “yes” to question #4b or 4c, describe the  
  
purpose of the recording and who will have access to these recordings. 
 
 
 
The video recording will be used to quantify the number of corrected responses 
participants made on the counting task. 
 
d. Is internet / email a part of the study? ............... ............................................................... 
Yes 
 No 
 
 If you answered “yes” to question #4d, describe how the internet and/or email 
will be used. 
 
 
 
      
 
 
5. What is the time commitment for the participants? Include the number of sessions, 
maximum time commitment per session, and the maximum cumulative time 
commitment. 
 
 
Each participant will be tested over 3 sessions (7 ± 2 days between two successive sessions). 
Thus, the whole experiment will take place over ~ 3 weeks. Each session is estimated to take 
about 2.5 hour. Thus, the maximum cumulative time commitment for each participant is 
approximately 7.5 hours.  
 
 
6.  Site / location of the study. 
 
 
a. 
Will participants be affiliated with a specific non-TWU agency, institution, or organization? ........  
 Yes 
 No  
 
 
 
If yes: 
 
 
 
Name of the site(s)?  
 
 
 
      
 
 
 
Affiliation of the principal investigator to this site(s)?  
 
 
 
      
 
 
 
Affiliation of the participants to this site(s)?  
 
 
 
      
 
 
 
 
Agency approval letters are required by the IRB before data can be collected at a site. If you answered 
“yes” to 6a, attach the signed agency approval letter on letterhead from each agency. If agency 
approval cannot be obtained prior to submitting the IRB application, explain here. 
 
 
 
      
 
 
b. 
Describe the setting of the study (i.e. physical location, surroundings, privacy aspects, etc.) 
 

June 2015 (revised Nov 2015) 
 
9 
 
 
The study will take place at the TWU – Dallas Campus.  Participants will undergo TMS 
procedure on the 1st floor in the Human Neurophysiology Lab. The gait assessment will 
take place on the 1st floor in the Motor Skill Lab. 
 
 
 
 
POTENTIAL RISKS AND PROTECTION OF PARTICIPANTS 
 
7. 
Explain the potential risks to the human participants involved in this research. All risks 
must be identified and listed on the consent form (if applicable). 
 
 
RISK 
STEPS TO MINIMIZE RISK 
Loss of confidentiality 
The investigators will attempt to maintain 
confidentiality to the extent that is allowed by 
law. The study will take place at Texas 
Woman’s University, School of Physical 
Therapy – Dallas Campus. Codes, rather than 
names, will be used in the data analysis and 
in the final report. The data will be stored in a 
locked file cabinet. The data recorded on 
papers will be stored for approximately 5 
years and then will be shredded.  The data 
recorded on disks will be stored for 5 years 
and then will be deleted.  It is anticipated that 
data will be published in books and/or 
journals. However, names or other identifying 
information will not be included in any 
publication. 
4.Loss of time 
The study requires 3 sessions and each 
session lasts 2 to 2.5 hours. The loss of time 
could potentially impact participants’ life.  
 
To minimize the impact of loss of time, all visits 
will be scheduled based on participant’s 
convenience. For example, on the same day 
that they come to Dallas Stroke Center for 
speech therapy appointments or during 
weekends.  
Loss of balance 
The gait assessment involves walking and 
turning in which participants may experience 
loss of balance.  
To minimize this potential risk, the tester will 
walk alongside the participants during testing.  
All testers are trained to detect and assist loss 
of balance during gait.  
5.Fatigue 
The study requires 3 sessions and each 
session lasts 2 to 2.5 hours. The length of the 
testing is necessary to obtain data needed. 
However, this might potentially result in fatigue 
due to the lengthy testing.   
 
To minimize this potential risk, we will schedule 
sufficient resting time between tests. In 
addition, participants may withdraw anytime if 
they are too fatigued to continue.  
RISK 
STEPS TO MINIMIZE RISK 

June 2015 (revised Nov 2015) 
 
10 
Headaches 
It has been shown that with repetitive 
stimulation on the scalp (in rTMS protocols), a 
small number of participants (< 28% cases) 
would develop transient headaches. The 
developed headaches usually resolved within 
3-4 hours and respond well to over-the-
counter pain medicine, such as 6.Tylenol. 
To minimize this potential risk, we will exclude 
participants who are prone to develop 
headaches (e.g. history of migraine). We will 
use subthreshold intensity for rTMS protocols 
that will reduce the likelihood of developing 
headaches.  
In addition, the tester will stop the testing 
when they develop headaches during the test. 
6.If participants do develop headaches and 
require pain medication, we will ask them to 
take the pain medication that has been 
approved by their primary care physicians.  
  
RISK 
STEPS TO MINIMIZE RISK 
Changes in auditory threshold 
There is a risk of alteration in auditory 
threshold after TMS protocols as TMS 
produces loud click when it is charged. The 
changes in auditory threshold are transient 
(lasts about 1 day) and not different from 
going to a music concert.  
 
To minimize the risk, we will provide earplugs 
during TMS testing. 
RISK 
STEPS TO MINIMIZE RISK 
Seizure 
Risk of seizure is associated with high 
frequency rTMS and is higher in those who 
have history of seizure, on medication that are 
known to reduce seizure threshold. Risk of 
seizure is also higher when the rTMS 
parameters are set outside of the safety limits.  
We will use a safety-screening questionnaire 
adapted from the recommendation of the 
international committee25,26. This 
questionnaire will help us to identify those at 
high risk of developing seizure and they will 
be excluded from participation.  
The rTMS protocols adopted in this project are 
within recommended safety limits25,26 and we 
have previously conducted rTMS experiments 
using the same protocols without any adverse 
events11,12.  
(Use continuation pages if necessary) 
 
 
8. 
Will participants be told about the intent of the study prior to participating?  .. 
 Yes 
 No 
 
If “no,” provide an explanation of why deception is necessary and the debriefing method to be used to 
fully inform the participants of the study's intent. 
 
      
 
 
9. 
Explain when and how the participants will be given the opportunity to ask questions. 
 

June 2015 (revised Nov 2015) 
 
11 
 
Participants will have the opportunity to ask questions anytime during the initial meeting with 
researchers or throughout the duration of the study. 
 
 
 
10. Identifiable Data 
 
 
 Outline the steps to ensure the confidentiality of identifiable data. Identifiable data 
includes documents, audio and video recordings, electronic data, and blood or other 
human specimens. 
 
 
a. 
Explain what identifiable data, if any, will be collected. 
 
Name, date of birth, gender, self and family medical history 
 
 
 
b. 
Where will identifiable data be stored? (Specify precise location, preferably in a locked file cabinet 
with limited access.) 
 
 
Identifiable data will be stored in a locked file cabinet in the School of Physical Therapy, 
Dallas Campus research lab room 8811. Access will be limited to the researchers.   
 
 
 
 
c. 
Give the date that identifiable data will be destroyed (mm/dd/yy). If identifiable data will be stored for 
an indefinite period of time, please explain. 
 
The identifiable data will be destroyed by 12/31/2020 by shredding all paper documents.  
Electronic data will be destroyed by 12/31/2020 by deleting all files containing identifiable 
data from any and all electronic devices including computers and portable storage 
devices. 
 
 
 
 
d. 
Identify specific ways that identifiable data will be destroyed at the end of this period of time.  
 
The identifiable data will be destroyed by 12/31/2020 by shredding all paper documents.  
Electronic data will be destroyed by 12/31/2020 by deleting all files containing identifiable 
data from any and all electronic devices including computers and portable storage 
devices. 
 
 
 
e. 
Because the academic component of TWU is classified as a non-covered HIPAA entity, identifiable 
health or health-related data cannot be transmitted electronically. You must be able to answer “no” to 
at least one of the following questions in order for your study to be approved. 
 
 
 
Does this research involve health or health-related data?  ........................................... 
 Yes 
 No 
 
 
If yes, are the data identifiable?  ..................................................................................... 
 Yes 
 No 
 
 
If yes, will data be transmitted electronically?  ............................................................... 
 Yes 
 No 
 

June 2015 (revised Nov 2015) 
 
12 
 
BENEFITS/REMUNERATION 
 
11. What will the participant receive for taking part in the study (i.e., financial remuneration, free 
services, access to information, and access to an intervention)? If there are none, state below that there 
are no direct benefits to the participant. 
 
Each participant will receive a gift-card worth USD 150 upon the completion of the experiment (3 
visits). In addition, they will have access to their own information (gait, neurophysiological data).  
 
12. What are the generalizable benefits of this study? (e.g., contribution to knowledge in 
field). 
 
This study will expand the knowledge in the field of neuroscience. In particular, it will identify 
important neural circuitry that supports human dual-task motor performance.  
 
 
13. Explain when and how the participants will be provided with the results of the study. 
 
Upon the completion of the study, the participants will receive a summary of the results (abstract 
format) upon their request.  
 
INFORMED CONSENT PROCEDURES 
 
 
14. Written Informed Consent 
 
 
a. 
Explain the PROCESS you will use to obtain informed consent. 
 
 
 
Prospective participants will have the opportunity to read a written informed consent form describing 
this study and ask questions regarding this study with research study personnel.  Each participant will 
sign the informed consent form in order to participate in this study after Institutional Review Board 
approval. 
 
 
b. 
Unless there are unusual circumstances, investigators are required to document informed consent by 
obtaining the participant’s signature (or the signature of their parent or guardian) on a written consent 
form. Explain when and how that signature will be obtained. Explain where the signed consent forms 
will be stored (specify precise location, preferably in a locked file cabinet with limited access), how 
long the signed consent forms will be kept, and identify specific ways that the signed consent forms 
will be destroyed at the end of this period of time. Note that a copy of the signed consent forms will 
need to be placed on file with the IRB when the study file is closed. 
 
 
 
The signature will be obtained after the prospective participant has read the written informed consent 
and agreed to participate. The signed consent forms will be stored in a locked file cabinet in the School 
of Physical Therapy, Dallas Campus research lab room 881l where only the researchers have access 
to it. The signed consent forms will be kept until 12/31/2020 and then be destroyed using a paper 
shredder. A copy of the signed consent form will be placed on file with the IRB when the study file is 
closed (estimated closing date  May 2018).  
 
 
c.  If you will not use a written consent form, provide a detailed rationale and explain how informed 
consent will be obtained 
 

June 2015 (revised Nov 2015) 
 
13 
 
 
N/A 
 
 
RESEARCH TEAM MEMBERS 
 
15. Provide a list of all research team members other than the investigator and faculty advisor.  
 
 
A current human subjects training certificate (less than 3 years old) must be on file for the 
investigator, advisor, and all research team members before an approval letter will be sent. These 
training certificates may be sent directly to the IRB separately or attached to this application in 
the attachment section. If a current training certificate is already on file with the IRB, there is no 
need to attach another copy. 
Name 
Delaina WalkerBatson 
TWU 7-digit Colleague ID # (if applicable) 
0066102 
Email Address: 
DWalkerBatson@mail.twu.edu 
TWU Department or Name of Other Institution 
Communication Sciences& Disorders, Stroke Center-
Dallas 
Role on Project 
Co-Investigator 
 
 
Name 
Alex Newton 
TWU 7-digit Colleague ID # (if applicable) 
1071827 
Email Address: 
mnewton4@twu.edu 
TWU Department or Name of Other Institution 
School of Physical Therapy 
Role on Project 
Research Assistant 
 
Name 
Isheanesu Nyangani 
TWU 7-digit Colleague ID # (if applicable) 
0996599 
Email Address: 
inyangani@twu.edu> 
TWU Department or Name of Other Institution 
School of Physical Therapy 
Role on Project 
Research Assistant 
 
Name 
Renee Vanasse 
TWU 7-digit Colleague ID # (if applicable) 
1107511 
Email Address: 
rvanasse@twu.edu 
TWU Department or Name of Other Institution 
School of Physical Therapy 
Role on Project 
Research Assistant 
 
Name 
Kevin Palm 
TWU 7-digit Colleague ID # (if applicable) 
1106859 
Email Address: 
kpalm@twu.edu 
TWU Department or Name of Other Institution 
School of Physical Therapy 
Role on Project 
Research Assistant 
 
 
(Attach additional sheets if necessary) 
 
 
 
 
 
ATTACHMENTS 

June 2015 (revised Nov 2015) 
 
14 
 
16. List and describe all attachments  (Include forms, scripts, flyers, consent forms, agency approval 
letters, human subjects training certificates, signed confidentiality agreement forms, referral lists, 
surveys, questionnaires, or any other instrument used in the study.) Attachments should be listed 
below in the same order in which they are attached. 
 
Advertising flyer 
TMS safety questionnaire  
         3.Mini Mental State Exam, Fugl-Meyer, Trail-Making Test 
IRB training certificates for each research personnel (6 copies) 
 
 
 
SUBMISSION INSTRUCTIONS 
 
The application should be submitted to the appropriate campus IRB. 
 
Denton and Dallas 
 
Mail the signed original to the address below. If electronic submission is preferred, combine all 
parts of application into single .pdf document and email to irb@twu.edu. If the application is 
submitted electronically as a fully signed .pdf, the original copy is not required. 
 
 
TWU’s Office of Research & Sponsored Programs 
 
Institutional Review Board 
 
PO Box 425619 
 
Denton, TX 76204-5619 
 
Applications may also be hand delivered to the Denton campus ACT 7th floor or the Dallas campus 
Office of Research IHSD 8th floor. 
 
Houston 
 
All parts of the application (including the signed cover page and appendices in order) should be 
combined into one single .pdf or Word document and emailed to irb-houston@twu.edu. The 
original copy is not required. If you have any difficulty with preparing a .pdf file, please contact the 
Houston Office of Research via email for assistance. 
 
 
RESPONSE TIMES 
Upon receipt of the application, the investigator will receive an email notifying them that the 
application has been received, the level of review that the application has been assigned, and the 
protocol number that has been assigned. Applicants can expect to receive a response from the 
IRB regarding the review within three weeks for an expedited application and within two weeks 
from the date of the meeting for a full review application. Note that these times are estimates and 
additional time may be required during certain times of the academic calendar such as summer, 
semester breaks, and Holidays. 
References:  
 

June 2015 (revised Nov 2015) 
 
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talking while walking on velocity and balance following a stroke. Age Ageing. 
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2. 
Choi JH, Kim BR, Han EY, Kim SM. The effect of dual-task training on balance and 
cognition in patients with subacute post-stroke. Ann Rehabil Med. 2015;39(1):81-90. 
3. 
Plummer-D'Amato P, Altmann LJ. Relationships between motor function and gait-related 
dual-task interference after stroke: a pilot study. Gait Posture. 2012;35(1):170-172. 
4. 
Yang YR, Chen YC, Lee CS, Cheng SJ, Wang RY. Dual-task-related gait changes in 
individuals with stroke. Gait Posture. 2007;25(2):185-190. 
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Plummer-D'Amato P, Altmann LJ, Saracino D, Fox E, Behrman AL, Marsiske M. 
Interactions between cognitive tasks and gait after stroke: a dual task study. Gait 
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techniques on corticospinal excitability in persons with chronic stroke: a pilot study. J 
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learning: a repetitive transcranial magnetic stimulation study. Eur J Neurosci. 
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Kakuda W, Abo M, Watanabe S, et al. High-frequency rTMS applied over bilateral leg 
motor areas combined with mobility training for gait disturbance after stroke: a 
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oriented training to improve symmetry of interhemispheric corticomotor excitability and 
gait performance after stroke: a randomized trial. Neurorehabil Neural Repair. 
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15. 
Al-Yahya E, Johansen-Berg H, Kischka U, Zarei M, Cockburn J, Dawes H. Prefrontal 
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Imaging Study. Neurorehabil Neural Repair. 2016;30(6):591-599. 
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Manor B, Zhou J, Jor'dan A, Zhang J, Fang J, Pascual-Leone A. Reduction of Dual-task 
Costs by Noninvasive Modulation of Prefrontal Activity in Healthy Elders. J Cogn 
Neurosci. 2016;28(2):275-281. 
17. 
Schabrun SM, Lamont RM, Brauer SG. Transcranial Direct Current Stimulation to 
Enhance Dual-Task Gait Training in Parkinson's Disease: A Pilot RCT. PLoS One. 
2016;11(6):e0158497. 
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Swank C, Mehta J, Criminger C. Transcranial direct current stimulation lessens dual task 
cost in people with Parkinson's disease. Neurosci Lett. 2016;626:1-5. 

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Wrightson JG, Twomey R, Ross EZ, Smeeton NJ. The effect of transcranial direct 
current stimulation on task processing and prioritisation during dual-task gait. Exp Brain 
Res. 2015;233(5):1575-1583. 
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Miyai I, Yagura H, Hatakenaka M, Oda I, Konishi I, Kubota K. Longitudinal optical 
imaging study for locomotor recovery after stroke. Stroke. 2003;34(12):2866-2870. 
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