Effects of Single-session Transcranial Direct Current Stimulation in Children With Cerebral Palsy
Phase: NA
Conditions: Cerebral Palsy, Perinatal Stroke, Periventricular Leukomalacia
Sponsor: University of Minnesota

PROTOCOL TITLE: Effects of single-session tDCS in children with cerebral palsy 
VERSION DATE: 04/30/2018 
 
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Protocol Title 
Effects of single-session transcranial direct current stimulation in 
children with cerebral palsy 
Principal 
Investigator/Faculty 
Advisor 
Name: Bernadette Gillick, PhD, MSPT, PT 
Department: Rehabilitation Medicine 
Telephone Number: 612-626-3121 
Email Address: gillick@umn.edu 
Student 
Investigator 
Name: Samuel Nemanich, PhD 
Current Academic Status (Student, Fellow, Resident): 
 Post-doctoral Fellow 
Department: Rehabilitation Medicine 
Telephone Number: 612-625-2822 
Institutional Email Address: nemanich@umn.edu 
Scientific 
Assessment 
Nationally based non-federal funding organizations 
IND/IDE # (if 
applicable) 
K060847, K143531, K170291 
IND/IDE Holder 
Magstim Corp, Soterix Medical, Inc 
Investigational Drug 
Services # (if 
applicable) 
N/A 
Version 
Number/Date: 
Version 1, 02/20/2018 
 

PROTOCOL TITLE: Effects of single-session tDCS in children with cerebral palsy 
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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Effects of single-session tDCS in children with cerebral palsy 
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Table of Contents 
 
1.0 
Objectives ................................................................................................................ 5 
2.0 
Background .............................................................................................................. 5 
3.0 
Study Endpoints/Events/Outcomes .......................................................................... 8 
4.0 
Study Intervention(s)/Investigational Agent(s)........................................................ 8 
5.0 
Procedures Involved............................................................................................... 10 
6.0 
Data and Specimen Banking .................................................................................. 14 
7.0 
Sharing of Results with Participants ...................................................................... 14 
8.0 
Study Population .................................................................................................... 14 
9.0 
Vulnerable Populations .......................................................................................... 15 
10.0 Local Number of Participants ................................................................................ 17 
11.0 Local Recruitment Methods ................................................................................... 17 
12.0 Withdrawal of Participants .................................................................................... 19 
13.0 Risks to Participants ............................................................................................... 20 
14.0 Potential Benefits to Participants ........................................................................... 23 
15.0 Data Management .................................................................................................. 23 
16.0 Confidentiality ....................................................................................................... 24 
17.0 Provisions to Monitor the Data to Ensure the Safety of Participants .................... 25 
18.0 Provisions to Protect the Privacy Interests of Participants .................................... 29 
19.0 Compensation for Research-Related Injury ........................................................... 30 
20.0 Consent Process ..................................................................................................... 30 
21.0 Setting .................................................................................................................... 31 
22.0 Multi-Site Research ............................................................................................... 31 
23.0 Resources Available............................................................................................... 31 
24.0 References .............................................................................................................. 33 
 

PROTOCOL TITLE: Effects of single-session tDCS in children with cerebral palsy 
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ABBREVIATIONS/DEFINITIONS 
 
AE 
 
Adverse Event 
AHA  
Assisting Hand Assessment 
ANOVA 
Analysis of Variance 
ANCOVA 
Analysis of Covariance 
BOLD  
Blood Oxygen-Dependent Level 
CIMT  
Constraint-induced Movement Therapy 
CMRR  
Center for Magnetic Resonance Research 
CNBD  
Center for Neurobehavioral Development 
CRF 
 
Case Report Form 
CTD  
Children with Typical Development 
CTSI  
Clinical and Translational Science Institute 
EMG  
Electromyography 
FLASH 
Fast Low Angle Shot 
GMFCS 
Gross Motor Function Classification Scale Score 
IHI 
 
Interhemispheric Inhibition 
iSP 
 
Ipsilateral Silent Period 
JTTHF  
Jebsen Taylor Test of Hand Function 
M1 
 
Primary Motor Cortex 
MP-RAGE 
Magnetization Prepared Rapid Acquisition Gradient Echo 
MACS  
Manual Abilities Classification Scale 
MB 
 
Multi-band 
MEP  
Motor Evoked Potential 
MRI 
 
Magnetic Resonance Imaging 
MT 
 
Motor Threshold 
NNL  
Non-invasive Neuromoduluation Laboratory 
SO 
 
Supraorbital Prominence 
NIBS  
Non-invasive Brain Stimulation 
PP 
 
Paired-pulse 
SAE 
 
Serious Adverse Event 
SimNIBS 
Simulation of Non-invasive Brain Stimulation 
rTMS  
Repetitive Transcranial Magnetic Stimulation 
tDCS  
Transcranial Direct Current Stimulation 
TMS  
Transcranial Magnetic Stimulation 
TR 
 
Time to Recovery 
UCP  
Unilateral Cerebral Palsy 
 
 

PROTOCOL TITLE: Effects of single-session tDCS in children with cerebral palsy 
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1.0 
Objectives 
1.1 Purpose: To characterize motor cortex neurophysiology and to understand 
how one form of non-invasive brain stimulation (NIBS) called transcranial 
direct current stimulation (tDCS) changes brain excitability and behavior in 
children diagnosed with cerebral palsy, as compared to children with typical 
development (CTD). 
Aim 1: Using transcranial magnetic stimulation (TMS), characterize brain 
excitability, specifically interhemispheric inhibition, in children with CP and 
CTD. 
Aim 2: Evaluate the immediate effect of tDCS on brain excitability and 
motor performance in children with UCP and CTD. 
Aim 3: Compare the responses to tDCS in each with individual estimated 
electric field intensity from computational modeling. 
2.0 
Background 
2.1 Significance of Research Question/Purpose: Hemiparesis, or weakness on 
one side of the body, is common following stroke early in life. The broader 
clinical diagnosis for this type of childhood movement impairment is 
unilateral cerebral palsy (UCP). Cerebral palsy effects about 3 out of every 
1000 live births in the Unites States1, and produces lifelong motor, sensory, 
and cognitive disability.  
Neurorehabilitation has primarily focused on intensive motor training to 
encourage use of the affected extremities in an effort to produce use-
dependent neuroplasticity in the brain. Such interventions are effective, but 
require a burdensome amount of time, 60-90 hours per week, for both the 
child and therapist. Furthermore, some children do not respond at all to such 
training. 
Neuromodulation is a relatively new field that aims to influence the brain’s 
neuronal activity through direct application of magnetic (TMS) or electric 
(tDCS) energy. It is thought the combination of neuromodulation and motor 
training may reduce the dosage of training needed, and would promote 
recovery to a greater extent for more individuals. Indeed, previous work in 
adult stroke demonstrate a benefit of combining repetitive TMS (rTMS) and 
tDCS with motor training, compared to training alone.2, 3 These types of 
synergistic interventions are just beginning to be used in children with UCP, 
with some preliminary data showing potential benefit. 
One of the many questions surrounding neuromodulatory interventions like 
tDCS is how to reliably predict changes in neuronal activity. The currently 
hypothesized effects of tDCS are polarity-specific: anodal tDCS depolarizes 
membranes resulting in increased in neuronal excitability; cathodal tDCS 
hyperpolarizes tDCS resulting in decreased neuronal excitability. 
Furthermore, these effects scale with the intensity of stimulation: the larger 

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the direct current delivered, the greater the change in excitability. This 
framework has been used to guide almost all studies using tDCS to produce 
a change in brain function and resulting behavior.  
More recently, the field is beginning to appreciate that this framework may 
be overly simplistic. For example, when a cognitive task is performed 
concurrently with tDCS, there are reported non-linear effects related to 
current intensity and direction of change in excitability.4 Such work has a 
significant impact on the use of tDCS in rehabilitation, which advocates for 
the pairing of stimulation with on-going activity. 
One common approach to using tDCS in individuals with stroke is to target 
the non-lesioned hemisphere. Following stroke, there is an imbalance of 
communication between brain hemispheres. This communication, known as 
interhemispheric inhibition (IHI), is a normal control process whereby the 
activated motor cortex sends an inhibitory command to the opposite motor 
cortex to momentarily interrupt its activity, allowing for the execution of 
controlled unilateral movements. IHI is exaggerated in the non-lesioned 
hemisphere after stroke, resulting in increased inhibition on the lesioned 
hemisphere.5, 6 Applying inhibitory current to the non-lesioned hemisphere 
may disinhibit this side and allow for recovery in the lesioned hemisphere. 
IHI is mediated through fibers passing through the corpus callosum and can 
be examined non-invasively using TMS. First and foremost, IHI has been 
shown to exist in children and young adults7, 8, indicating that this 
mechanism is not exclusively a feature of the developed adult nervous 
system. The effect of NIBS to modulated IHI has been demonstrated in 
adults with stroke, but less clearly in children. One reason for this is a lack 
of data characterizing IHI in children after perinatal brain injury. It is 
feasible, through ongoing adaptive and maladaptive neuroplasticity, that IHI 
is weakly present (or not at all) in these children as compared to adults. As 
studies continue to focus on NIBS interventions targeting the non-lesioned 
hemisphere, a more comprehensive understanding of the motor control 
mechanisms present in children with UCP is needed to guide these 
interventions. Therefore, one objective of this study is to characterize IHI of 
both brain hemispheres in children with UCP.  
At the moment, it is unclear what the acute effects of a single session tDCS 
are, when paired with motor training, on brain excitability or motor 
performance in children with and without UCP. This leads us to designing 
the proposed study, which will offer insight into the mechanisms of tDCS 
and lead the field toward a better understanding of how tDCS be 
implemented in a neurorehabilitation setting for both children and 
potentially adults.  

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2.2 Preliminary Data: Data from our 
previous study using TMS 
demonstrates the potential effect 
of cathodal tDCS to decrease 
cortical excitability. In a subset 
of 10 children, five of who 
received real stimulation and 
five received sham stimulation, 
we observed a decrease in motor 
evoked potential (MEP) 
amplitude following the two-
week intervention period (Figure 
1). These results indicate a 
potential neurophysiologic effect 
on the non-lesioned hemisphere 
using a small dose (0.7 mA) of 
tDCS. No effects on the excitability 
of the lesioned hemisphere were 
noted.  
2.3 Existing Literature: In one study of children with UCP, Kirton et al. used 
repetitive TMS to down-regulate the non-lesioned hemisphere, thereby 
decreasing IHI, in an effort to improve function of the more-affected upper 
limb.9 They found increases in grip strength in a small sample after the real 
intervention compared to a sham intervention. The same group also explored 
IHI in CTD, showing that IHI decreased with age and was correlated with 
unimanual performance.  
The proposed study will, at the moment, be the first to offer comprehensive 
data specifically on interhemispheric inhibitory control mechanisms in 
children with UCP. We predict that children with intact functional 
connections from the lesioned hemisphere will show IHI, while those with 
only connections from the non-lesioned hemisphere will not.  
The neurophysiologic effects of tDCS have not been widely reported in 
children with UCP. One study showed an increase in lesioned hemisphere 
excitability following anodal tDCS following 10 sessions of combined 
motor training and tDCS.10  
The proposed study is novel in that we will measure physiologic responses 
immediately following stimulation to capture the acute effect of the 
intervention and to potentially target its neural mechanisms. Immediate 
effects of tDCS are thoroughly described in healthy adult populations4, 11 but 
are less described in people with neurologic conditions. Furthermore, 
comparing physiologic and behavioral responses with computational 
modeling of electric fields produced by tDCS is a novel approach toward 
predicting responsiveness to brain stimulation interventions. The results 
from this study will help guide future usage of combined tDCS and motor 
training interventions in larger clinical trials.  
Figure 1. Change in brain excitability 
following tDCS. Children receiving 
cathodal tDCS (red line) showed a decrease 
in excitability compared to those in the 
sham group (black line). 

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3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: The primary outcome is magnitude of 
brain excitability as measured by motor evoked potentials from TMS. The 
primary behavioral outcome is time to complete a novel movement task. 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): The secondary 
neurophysiological outcomes are interhemispheric inhibition as measured 
by ipsilateral silent period (iSP) and paired pulse (PP) TMS (see 5.2 Study 
Procedures). The secondary behavioral outcomes are the Box and Blocks 
Test and Grip Strength. Safety and tolerability of the study, as measured 
through our participant-report of symptoms questionnaires, are also 
secondary outcomes.  
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 Description: Non-invasive brain stimulation has been recently investigated 
for benefits in recovery of motor function in adults2 and more recently in 
children.12, 13  One form, Transcranial Magnetic Stimulation (TMS), can be 
used in specific protocols either to test cortical excitability or as an 
intervention to attempt to influence cortical excitability. In this study we are 
using TMS only as a test to assess cortical excitability in the area of the 
brain known as the motor cortex or M1. Recent evidence suggests that 
1.0mA and 2.0mA is well-tolerated and results in motor learning both for 
children with typical development14 and 1.0 mA in children with 
hemiparesis.15 Safety of tDCS is further demonstrated in a recent evidence 
based update with no reports of major adverse events following tDCS.16 
Transcranial Direct Current Stimulation (tDCS) will be used as an 
intervention, applying stimulation continuously over a period of 20 minutes. 
 
Testing cortical excitability: Transcranial Magnetic Stimulation (TMS): We 
will use a Magstim Rapid2 TMS stimulator (Magstim Corp, Dyfed, UK) 
with a flat 70 mm figure-of-eight coil. TMS is a non-invasive method for 
assessing the excitability of the brain. The TMS stimulator is a non- 
significant risk device. The technique involves placing a special electrode on 
the head. 
 
We will use a flat figure-of-eight coil with a 70-mm diameter for each loop 
of the figure-of-eight. The center of the coil is hand held on the scalp over 
the desired region to be stimulated. An electrical current is pulsed through 
the electrode, which creates a magnetic field. This magnetic field, in turn, 
creates an electric field in the surrounding area, including inside the skull, 
which induces an ionic current to flow on the surface of the brain. 
Depending on the parameters of the stimulation and the excitability of the 
underlying cortex, the stimulation may or may not depolarize the nerve 
membrane to threshold. If it does depolarize, an action potential is generated 
and conducted to spinal motor neurons, which, depending on their own 
excitability, may transmit an action potential to muscle. Ultimately, the 

PROTOCOL TITLE: Effects of single-session tDCS in children with cerebral palsy 
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response is recorded MEP with electromyography (EMG) electrodes located 
over the target muscle. 
 
Intervention: Transcranial Direct Current Stimulation (tDCS): One of two 
potential tDCS devices will be used. The first is a Soterix Medical 1x1 
stimulator (Soterix Medical, New York, NY). This device is intended for the 
noninvasive stimulation of the cortex via transcranial current stimulation. 
The device is capable of direct current stimulation up to 1.5 mA and has a 
built-in sham condition setting. This sham stimulation feature allows for 
consistent application of the sham setting with ramp-up, extinguish and 
ramp-down modulation. As an added measure of safety, we will be using the 
Limited Total Energy (LTE) device which provides built-in adaptation to 
resistance and current. These devices are for investigational research only in 
the United States.  
 
An instructional video from the Harvard Berenson- Allen Center for 
Noninvasive Brain Stimulation describes the use of Soterix tDCS in detail.  
 
All investigational devices used in this study will have the following label 
statement: CAUTION – Investigational Device. Limited by Federal law to 
investigational use. 
 
Stereotactic Neuronavigation: In order to verify our exact location over the 
motor cortex we will be using a computerized method of location called 
Stereotactic Neuronavigation (SNN-Brainsight Stereotactic 
Neuronavigation, Rogue Research, Montreal, Canada). Through the use of a 
locator situated atop the TMS device and a comparative subject- specific 
magnetic resonance imaging (MRI) image on a computer screen which 
shows the locator position, we will be able to specify the TMS hotspot 
location and placement of the tDCS electrodes.  
Three-tesla (3T) Magnets for MRI will be used through the Center for 
Magnetic Resonance Research (CMRR). These devices pose a non-
significant risk and have a claim of an abbreviated IDE. 
4.2 Drug/Device Handling: All tDCS stimulators, electrodes, and related 
supplies will be stored in a locked closet inside the Gillick laboratory space, 
which requires keypad access. For each study, the research team will 
transport the device to the testing facility (Neuromodulation Lab, 717 
Delaware Bldg.) for the day. The devices will be returned to the Gillick lab 
at the end of data collection. 
IND/IDE:  
Device 
510(k) Number(s) 
Applicant 
TMS 
K060847, K143531 
Magstim Corp US, LLC Woburn, MA 

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IRB Approval
Recruitment
Medical 
Record 
Review
Enrollment
Begin Study
Interest?
Not 
Eligible
Ask to be 
contacted for 
future studies
Eligible
Baseline
Assessments
• MRI
• TMS (A-D)
• Behavioral 
Intervention
Sham or 
Real
tDCS+Motor
Task
Post-intervention
t=0
t=15min
t=30min
t=60min
Randomized
Immediate
Time After tDCS
Test
Test
Test
Test
tDCS 
K170291 
Soterix Medical Inc., New York, NY 
 
5.0 
Procedures Involved 
5.1 Study Design: This is a randomized, sham-controlled, double-blinded study. 
The intervention consists of a single, 20 minute session of tDCS paired with 
motor training (see Figure 2). Participants will be randomized to either real 
or sham tDCS. The participants and the members of the research team 
involved in assessments and testing will be blinded to intervention group 
(real or sham tDCS), but the other research staff/PI/Co-Is will be unblinded.  
5.2 Study Procedures:  
Pre-study 
 
 
Participant Screening and Enrollment 
Participants will be initially screened for inclusion and exclusion criteria 
during a phone interview (Appendix A). Initial consent will be obtained 
over the phone to allow the caregiver to disclose protected health 
information (PHI) about his/her child. If the family is interested following 
this phone screen, we will obtain HIPAA consent to perform a medical 
record review (Appendix B and C). A review is then completed by the study 
medical director for review of inclusion/exclusion by history and MRI/CT 
radiographic reports of the brain (Appendix D). Eligibility will be verified 
by the principal investigator after this review. Eligibility is then discussed 
with the legal guardian and a formal schedule is established. A pre-study 
letter will then be sent (Appendix E). Informed consent/assent will be 
completed before on the day of the MRI acquisition. 
Figure 2. Pre-study timeline and study design. 

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The research team will utilize the CMRR Center’s screening tools and 
adhere to the screening SOP during enrollment of all research participants in 
this protocol. The CMRR Center’s screening tools and SOP are IRB 
approved under the CMRR Center Grant (HSC# 1406M51205) and 
information regarding screening procedures is publically available on the 
CMRR website.  
Randomization 
Participants will be randomly assigned to receive real or sham tDCS. 
Children with presence of a lesioned hemisphere MEP response may receive 
1) ipsilesional anodal; 2) contralesional cathodal tDCS or 3) sham tDCS. 
Children without a lesioned hemisphere MEP may receive 1) contralesional 
anodal or 2) sham tDCS. Participants and their families will be blinded to 
group assignment. Participants will be unblinded after completing the study.  
Magnetic Resonance Imaging (MRI) Acquisition 
Location: Center for Magnetic Resonance Research (CMRR) 
Time: 1 hour (including preparatory time) 
MRIs will be performed at the CMRR on the University of Minnesota 
campus. We will obtain a structural image of brain anatomy to be used for 
stereotactic neuronavigation and individual brain modeling described below 
(Pre-Test Assessment: TMS and Computational Modeling).  
Children and their caregivers will be screened using pre-approved CMRR 
safety screening forms. Children will change into scrubs and be given a 
“tour” of the scanning facility room. In our experience, this can alleviate 
anxiety related to MRI scanning in children. Caregivers will be allowed to 
watch through the control room window. 
When ready, children will lie on the scanner bed comfortably with 
cushioning, pillows, etc.  A movie of their choice will be projected behind 
them to watch during the scan. Scanning will consist of a localizer sequence 
(< 1min), and a T1-weighted magnetization prepared rapid acquisition 
gradient echo (MP-RAGE)  sequence (spatial resolution 1 mm isotropic, < 
6min), T2-weighted fast low-angle shot (FLASH) sequence (spatial 
resolution 0.7x0.7x4.0 mm, < 6min), a pair of diffusion scans (spatial 
resolution 1.5 mm3), a task fMRI blood oxygen-dependent level (BOLD) 
scan and a resting-state fMRI BOLD scan (spatial resolution 2mm3, TR = 
0.8s, MB = 8). If image quality is not deemed acceptable, we will repeat the 
T1-sequence as needed. Children will be able to talk to the scan operator at 
any time.  
Day of Study  
Location: Non-invasive Neuromodulation Lab—Clinical and Translational 
Science Institute (CTSI) or Pediatric Brain Stimulation Lab—Center for 
Neurobehavioral Development (CNBD) 
Time: 3 hours 

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Pre-Test Assessment: TMS 
All procedures will be performed on the non-lesioned, then lesioned 
hemisphere unless noted otherwise.   
A. Motor threshold (MT): To find the motor threshold, we will begin 
testing at the estimated location of the hand region of motor cortex as 
identified on the reconstructed brain image in the stereotactic 
neuronavigation system. We will test at 50% MSO. The motor threshold, 
is defined as the lowest stimulator output that produces MEPs of at least 
50 µV on 50% (i.e. 5 of 10) trials. The location associated with the 
motor threshold is denoted as the motor hotspot. We will test up 100% 
MSO if tolerated by the participant to determine a motor threshold. 
B. MEP Amplitude: Twenty pulses will be delivered at the motor hotspot 
using a testing intensity equivalent to 120% of the MT.  
C. Cortical Silent Periods: Twenty pulses will be delivered at the motor 
hotspot using a testing intensity equivalent to 120% of the MT with the 
target hand muscle activated. 
D. Paired-Pulse Assessment: Using two TMS coils, a conditioning stimulus 
will be delivered to one hemisphere at an intensity equivalent to 100% 
MT. Simultaneously, a test stimulus will be delivered to the opposite 
hemisphere at an intensity equivalent to 120% RMT. A total of 20 pairs 
of stimuli will be used (10 with interstimulus interval = 10 ms, ten with 
interstimulus interval = 0 ms), delivered in a pseudorandom order. 
Pre-Test Assessment: Behavioral 
We will use the Gross Motor Function Classification Scale Score (GMFCS), 
and the Manual Ability Classification System (MACS) as clinical 
characterization of each participant. Members of the research team will 
assess hand function using the following measures: Assisting Hand 
Assessment (AHA), Box and Blocks Test, Grip Strength Dynamometry, and 
Jebsen Taylor Test of Hand Function (JTTHF). A novel motor performance 
task will also be employed to assess motor performance and potential effects 
of tDCS on motor learning.  
Intervention  
The intervention will last a total of 30 minutes, including preparatory time. 
Before stimulation, the area of skin underneath the electrode will be 
inspected for abrasions/lesions and then cleaned with an alcohol swab. We 
will use an M1-SO electrode montage, where one tDCS electrode is placed 
on the motor hotspot (M1) as determined by TMS testing, and the other 
electrode is placed on the supraorbital prominence (SO) of the opposite side. 
Sanitized rubber electrodes housed in single-use, sterile 3 cm x 5 cm 
sponges moistened with saline will be placed on the stimulation sites and 
held in place by elastic bands. To ensure adequate electrical conductance, 
care is taken to maintain firm contact of the sponge to the scalp. The static 

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impedance measurement is checked and stimulation does not proceed unless 
levels are within limits recommended by the tDCS device manufacturer. 
Children in the sham group will receive the same procedures as the active 
tDCS group, yet the device will be set to an integrated sham setting which 
extinguishes the current after a 30 second to 1 minute ramp-up phase and 
gradually reintroduces the ramp-down at the end of the 20 minute session.  
After the first 2 minutes of stimulation, the participant is questioned about 
pain at the electrode sites. If the stimulation is painful, a small amount of 
additional saline (2-4 mL) is added to the sponge, taking care to avoid 
wetting adjacent hair and thereby increasing the electrode area, and the 
tightness and placement of the band are checked. If pain persists, the 
stimulation intensity is decreased, and symptoms re-assessed.  If pain still 
persists, stimulation is stopped and the electrode sites are checked. This 
procedure is repeated twice (every 5 minutes during tDCS) with saline 
solution (2-4 mL) added as needed. 
Participants will receive a total of 20 minutes of active or sham tDCS. 
During stimulation, participants will practice the novel reaching task 
described above at a comfortable pace. No conversations between 
participant and researchers or caregivers will be allowed, except those that 
pertain to safety. 
Post-intervention Assessments 
Immediately following the intervention, TMS and Behavioral assessments 
will be performed at 0, 15, 30, and 60 minutes following the intervention 
(see Figure 2). 
Other Procedures 
Computational Modeling 
Computational modeling of electric fields produced by tDCS will be 
performed using SimNIBS (Simulation of Non-invasive Brain Stimulation). 
Using T1-anatomical images, individual skull and brain anatomy will be 
reconstructed, and electric fields computed using a finite element method. 
The primary outcome is the estimated peak electric field strength for the 
M1-SO montage.  
Safety Monitoring 
We will use questionnaires (Appendix F) to document symptoms associated 
with non-invasive brain stimulation before and after the intervention and 
testing session. This tool asks participants about the presence and severity of 
symptoms such as tingling, itchiness, and headache. We will also measure 
heart rate and blood pressure before and after the procedures.  
Follow-Up: A member of the research team will contact each participant 
and their caregivers within one week of completing the study to check for 
any adverse events. There is no long-term follow-up data collection planned. 

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5.3 Study Duration: Each participant will complete the study in either one day 
(MRI and intervention, four hours total) or on two separate days (one hour 
MRI, and three hours intervention). If done on two days, the MRI and 
intervention will be separated by no longer than a two week (14 day) period. 
We expect to enroll all participants, both CTD and children with UCP, in a 
24-month time period after the approval of the study.  
All study procedures and data analysis will be completed within 36 months 
from the approval of the study. 
 
5.4 Individually Identifiable Health Information: Protected Health Information 
will be obtained from participants in this study.  A HIPAA authorization 
release form will be signed by the participant (if older than 18) or the 
parent/legal guardian of the participant (if younger than 18) to allow the 
researchers to use this information for research purposes.  
 
5.5 Use of Radiation: N/A 
 
5.6 Use of Center for Magnetic Resonance Research: This research will involve 
the Center for Magnetic Resonance Research (CMRR) facilities. See 
attached Pre-IRB approval from the CMRR.  
6.0 
Data and Specimen Banking 
6.1 Storage and Access: Urine specimens will be obtained for pregnancy testing 
(Icon 25HCG One-Step, Beckman Coulter, Brea, CA) of all pubescent 
females and immediately used for assessment of pregnancy status. 
Specimens are discarded at the CTSI through specimen procedures. 
6.2 Data: No data elements will be collected and banked 
6.3 Release/Sharing: The results of pregnancy tests, if positive, will not be 
shared with the participant or his/her caregiver. Instead, they will be 
informed that they no longer meet the inclusion/exclusion criteria to 
continue in the study. 
7.0 
Sharing of Results with Participants 
7.1 This study is not designed to produce a direct benefit to the participant. We 
will not share specific individual results with participants and families. At 
the time of publication of any manuscripts associated with this study, we 
will send a lay summary and a copy of the article to each participant and 
their family. 
8.0 
Study Population 
8.1 Inclusion Criteria: Participants with UCP must have a clinical diagnosis of 
cerebral palsy with confirmed radiologic evidence of hemispheric stroke or 
periventricular leukomalacia. 

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All participants (UCP and CTD) will be eligible if they meet all of the 
following criteria: 
1. Aged between 7 years 0 days and 21 years, 355 days (see 10.2 
Vulnerable Populations) 
2. Able to give informed assent (if under 18 years of age) 
3. Able to follow 2-step commands 
4. Presence of an MEP in the less affected (UCP) or non-dominant (CTD) 
hand when stimulating the non-lesioned hemisphere 
8.2 Exclusion Criteria: Participants will be excluded if they meet any of the 
following criteria: 
1. Evidence of a seizure within the past two years  
2. Other neurological or metabolic conditions/diagnoses  
3. Treatment with injectable agents (e.g. Botox) for spasticity management  
4. Is pregnant (females only) 
5. Presence of indwelling metal in the head (e.g. aneurysm clip) or medical 
device. Dental braces are allowable if approved by the CMRR safety 
monitor and PI. 
8.3 Screening: Participants will be rigorously screened against 
inclusion/exclusion criteria to ensure that their participation is safe. This 
screening begins at the initial discussion in the phone screen, continues with 
review of the medical record by the PI and Medical Director, and is again 
repeated in-person by reviewing the medical record (Appendix D). All 
pubescent (verification of menstrual cycle from caregiver/parent) female 
participants will need to take a urine pregnancy test. If the test is positive, 
the participant will be excluded from the study as the safety of use of tDCS 
and TMS during pregnancy has not been established.  
 
The research team will utilize the CMRR Center’s screening tools and 
adhere to the screening SOP during enrollment of all research participants in 
this protocol. The CMRR Center’s screening tools and SOP are IRB 
approved under the CMRR Center Grant (HSC# 1406M51205) and 
information regarding screening procedures is publically available on the 
CMRR website. 
 
9.0 
Vulnerable Populations 
9.1 Vulnerable Populations:  
☒ Children 
☐ Pregnant women/Fetuses/Neonates 
☐ Prisoners 

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☐ Adults lacking capacity to consent and/or adults with diminished 
capacity to consent, including, but not limited to, those with acute 
medical conditions, psychiatric disorders, neurologic disorders, 
developmental disorders, and behavioral disorders 
☐ Approached for participation in research during a stressful situation such 
as emergency room setting, childbirth (labor), etc. 
☐ Disadvantaged in the distribution of social goods and services such as 
income, housing, or healthcare 
☐ Serious health condition for which there are no satisfactory standard 
treatments 
☐ Fear of negative consequences for not participating in the research (e.g. 
institutionalization, deportation, disclosure of stigmatizing behavior) 
☐ Any other circumstance/dynamic that could increase vulnerability to 
coercion or exploitation that might influence consent to research or 
decision to continue in research 
☐ Undervalued or disenfranchised social group 
☐ Members of the military 
☒ Non-English speakers 
☐ Those unable to read (illiterate) 
☐ Employees of the researcher 
☐ Students of the researcher 
☐ None of the above 
9.2 Additional Safeguards: We are studying children and young adults aged 7-
21 with a specific diagnosis of cerebral palsy. As we are a pediatric 
laboratory with experienced pediatric researchers, clinicians and trainees, 
comprehensive efforts have been made to ensure that our procedures are 
developmentally appropriate to both child and family. Recruitment 
materials, study information, and conversations are tailored to a pediatric 
population. Participant-specific study materials are provided before 
participation in interventions and testing sessions, and age-appropriate 
adaptations for each procedure/test are used. Our team has created videos 
that help explain the research and procedures to families. These videos can 
be viewed at any time before enrolling or participating in the study. (Gillick 
Lab Video; TMS Video). We also have a network of past participant 
families who have offered to share their experiences in our research studies 
with potential participants.  
 
For MRI testing, we introduce children to the MRI environment with a 
mock scanner, consisting of a “tunnel” in which children can lie. This 
provides an indication of the dimensions of the actual scanner. We will 
provide audio files of scanner sounds to familiarize children with MRI 
sounds. During the actual scan, children can watch a movie or listen to 
music. Although the caregivers will have the ability to see their child in the 
scanner from the control room, if necessary, a caregiver may stay with the 

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child in the scanner room (assuming the caregiver meets all MRI safety 
criteria). Children and families will be given the opportunity to tour the 
TMS testing intervention rooms to ask questions about the equipment and 
technology.   
 
During the intervention and testing session, behavioral and environmental 
strategies will be implemented for all children to optimize tolerance and 
completion of each session. These may include but are not limited to: 
predictable routines, visual timer, distraction techniques, child-friendly 
descriptive language, and positioning.  
 
Our team is trained to be attentive to the child’s mood and comfort, which 
are important factors when asking children to engage in long testing 
sessions. Throughout their participation, the research team will continually 
check in with the participants for real-time verbal feedback on their 
experience. We recognize the value and importance of feedback from 
children and families about their experience during the study, and have 
developed surveys to collect this type of information (Appendix G). We will 
continue to adapt study procedures based upon this feedback. We will 
provide drinks and snacks throughout the child’s participation in the study 
and provide breaks as necessary.  
For non-English speaking participants, we will work with the IRB and other 
community groups to provide all information in the participant’s native 
language. 
10.0 Local Number of Participants 
10.1 Local Number of Participants to be Consented: Based on recruitment in 
previous studies in this population performed by our lab, we expect that 
about 75% of our sample of children with UCP will reside in the state of 
Minnesota. The remaining 4 participants will be recruited from the greater 
Midwestern and Western regions. We expect to enroll all CTD from the 
greater Twin Cities Metropolitan area. The maximum number of enrolled 
participants is 40 children with UCP and 10 CTD.   
11.0 Local Recruitment Methods 
11.1 Recruitment Process: Recruitment will take place immediately after 
approval and continue, at the latest, through the 24th month of the study. We 
expect most participants will be recruited from the state of Minnesota. 
Based on our previous recruitment data, approximately 25% will reside in 
other states.  
We will use established databases from our previous work, totaling nearly 
400 children with UCP who, barring changes in medical status, meet the 
proposed study criteria. In addition, we will recruit using the following 
sources/methods: other existing databases, newspaper advertisements, 
television/radio programs, webpages (the Children’s Hemiplegia and Stroke 
Association (chasa.org), HemiKids website (http://www.hemikids.org/), 

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ResearchMatch.com), social media, and clinician contact postings We have 
experienced exceptional participation (increase in overall enrollment in our 
studies from 9% to 14% over the last 5 years), retention (100% in 3 studies 
of 50 total children), and adherence (99.8%) in our trials of over 539 total 
visits. 
Source of Participants: With IRB approval, we will screen children for 
research recruitment through physician-based referrals. This has been our 
most effective recruitment tool to date (>57% of referrals) and will allow 
expansion of our current database. Additional sources are the local, state, 
and national communities that respond to advertisements and postings on 
websites described in Section 12.1  
11.2 Identification of Potential Participants: All interested caregivers/participants 
will be screened on the telephone by the study coordinator or an authorized 
member of the research team to determine if the child meets the 
inclusion/exclusion criteria using IRB-approved pre-screening forms 
(Appendix A). Following telephone screen, we will send the 
caregiver/participant a medical record release form that grants release of 
their child’s medical records to further determine eligibility (Appendix B 
and C). When we receive this signed form, we will submit it to the 
appropriate hospital/clinic. The medical director will review the medical 
records for appropriate inclusion.  
11.3 Recruitment Materials: We will use emails (Appendix H) and printed flyers 
(Appendix I) to advertise this study.  
11.4 Payment: Participants will be paid $50 in the form of a debit card after 
completing the study. The Greenphire ClinCard will be used for payments.  
Payment will be made using a pre-paid debit card called Greenphire 
ClinCard. It works like a bank debit card. We will give you a debit card and 
each time you receive a payment for participation in this study, the money 
will be added to the card after each completed visit. 
 
You may use this card at any store that accepts MasterCard or you can use a 
bank machine to remove cash. However, there may be fees drawn against 
the balance of the card for cash withdrawals (ATM use) and inactivity (no 
use for 3 months). We will give you the ClinCard Frequently Asked 
Questions information sheet that answers common questions about the debit 
card. You will also receive letters with additional information on how you 
can use this card and who to call if you have any questions. Be sure to read 
these letters, including the cardholder agreement, for details about fees.  
 
The debit card system is administered by an outside company. The 
company, Greenphire, will be given your name. They will use this 
information only as part of the payment system. Your information will not 
be used for any other purposes and will not be given or sold to any other 
company. Greenphire will not receive any information about your health 
status or the study in which you are participating. 

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Any demographic information collected and provided to Greenphire is 
stored in a secure fashion and will be kept confidential, except as required 
by law. 
 
Payment you receive as compensation for participation in research is 
considered taxable income. If payment to an individual exceeds $600 in any 
one calendar year, the University of Minnesota is required to report this 
information to the Internal Revenue Service (IRS). Research payments to 
study participants exceeding $600.00 during any calendar year will result in 
a FORM 1099 (Miscellaneous Income) being issued to you and a copy sent 
to the IRS. 
 
At the end of the study, you will be provided with information regarding 
how your hand movements changed before and after the intervention. This 
information is not intended to have clinical significance. 
12.0 Withdrawal of Participants 
12.1 Withdrawal Circumstances: Participants will be withdrawn from the study 
under any of the following scenarios: 
Death: Study stopped for both individual and entire trial. Full investigation 
of event explored by entire study team. Medical monitor to review all 
details. Report of event will be distributed to all governing and monitoring 
committees. 
Seizure—Individual: If at any time during the study procedures a participant 
experiences a seizure, testing will be immediately suspended for that 
individual and the study team will follow seizure management guidelines. 
Refer to comprehensive seizure management outline (Appendix J) and the 
complete seizure observation documentation form (Appendix K). A letter 
from the Study Physician will be sent to the participant. (Appendix L). The 
medical director will recommend further evaluation of the child by pediatric 
neurologist or pediatrician routinely involved in the child’s care.  
 
An identification of causality and re-evaluation of treatment design will be 
performed by study researchers, including consultants, medical monitor and 
physicians in order to proceed. All procedures will be assessed for strict 
adherence to all intervention steps listed in the protocol. If deviation is 
found, the error will be corrected.  
 
Seizure—Multiple: If more than one individual experiences a seizure during 
the participation in the study, the entire study will be stopped and a thorough 
review performed by the research team and medical monitor. If a change in 
protocol is deemed necessary for the safety of participants, an amendment 
will be submitted to the IRB. 
 

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12.2 Withdrawal Procedures: If a participant voluntarily withdraws, we will ask 
the participant if we can continue to use information collected from any data 
collected up until that point. They will have the option to re-enroll at a later 
time if desired. 
12.3 Termination Procedures: If a participant is removed from the study by one 
of the investigators, any data collected up until the point of termination will 
be used after termination.  
13.0 Risks to Participants 
All research procedures will be performed by experienced personnel who 
have completed required training, including human participants, HIPAA, 
and CMRR training.  
13.1 Foreseeable Risks: The tables below outline the anticipated risks associated 
with tDCS, TMS, and MRI, our plan to mitigate each risk, and the 
probability of each risk (Improbable--No reported cases, unlikely (few 
reported cases), likely (many reported cases). Most risks are reversible with 
proper medical care/treatment, however there is less information on this 
aspect of risk mitigation.  
Risks Associated with Transcranial Direct Current Stimulation (tDCS) 
Anticipated Risks 
Risk Mitigation 
Probability of Risk 
Burn- Electrolysis 
Ensure proper electrode contact 
with skin 
Unlikely 
Stimulation in 
participants with 
reduced sensation 
Assess sensation, avoid placing 
electrodes over areas of 
decreased sensation 
Unlikely 
Stimulation over 
broken skin, reduced 
resistance 
Assess skin integrity, avoid 
placement of electrodes over 
recent shaving, skin defects 
Unlikely 
Stimulation over 
conductive implants 
Screen appropriately for 
exclusion criteria of implants 
Improbable 
Stimulation over a 
tumor which may 
alter metabolic 
activity 
Screen appropriately for 
exclusion criteria of neoplasm. 
Improbable 
Threshold altering 
pharmacologic agent 
Physician review of each medical 
record for determination of 
appropriateness for study 
inclusion. 
Improbable/Unknown 
Itching, Tingling, 
Burning Sensation 
Ensure proper contact of surface 
electrodes with skin. Maintain 
Likely 

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in the area of the 
electrodes 
current dosage within low-range 
of researched dosages. Ensure 
that electrode sponges are 
properly sanitized and that saline 
solution is appropriately 
employed. 
Headache 
Ensure that headband securing 
electrodes is in proper 
placement, yet not to the level of 
impingement of scalp area. 
Maintain current dosage within 
low range of delivery. 
Likely 
Pain- Neck, Scalp 
Ensure that electrodes are in 
proper contact with skin and 
adjust head position as needed 
for comfort. 
Unlikely 
Skin Redness 
Ensure proper electrode position 
and proper level of moisture to 
even stimulation across the 
electrode 
Likely 
Fatigue, Sleepiness 
Screen for continuous effect at 
follow-up visit.  
Unlikely 
Concentration or 
Mood Changes 
Evaluate cognitive status through 
physician examination and 
psychometric testing at three 
time points. 
Unlikely 
 
Risks Associated with Transcranial Magnetic Stimulation (TMS) 
Anticipated Risks 
Risk Mitigation 
Probability of Risk 
Stimulation over a 
tumor which may 
alter metabolic 
activity 
Screen appropriately for 
exclusion criteria of neoplasm. 
Improbable 
Threshold altering 
pharmacologic agent 
Physician review of 
each medical record for 
determination of 
appropriateness for 
study inclusion. 
Improbable 
Headache 
Screen for continuous effect 
throughout session through 
Likely 

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planned and spontaneous inquiry 
as well as invitation to report 
discomfort at any time. 
Fatigue, Sleepiness 
Screen for continuous effect 
throughout session through 
planned and spontaneous inquiry 
as well as invitation to report 
discomfort at any time. 
Likely 
Temporary mild 
hearing loss due to 
noise level of 
equipment 
Ear plugs will be inserted 
before commencement of 
TMS application. 
Unlikely 
 
We will use IRB-approved screening forms provided by the CMRR to 
screen both participants and caregivers accompanying participants. This 
screening will occur immediately prior to scanning.  
Risks Associated with Magnetic Resonance Imaging (MRI) 
Anticipated Risks 
Risk Mitigation 
Probability of Risk 
Claustrophobia 
Screening for history of fear of 
small spaces, introduction of 
MRI environment before 
scanning 
Likely 
Metal projectiles 
Thorough participant 
and caregiver screening 
before scan, high-
quality safety practices 
of research team 
Unlikely 
Interruption of 
implanted medical 
devices or dislodging 
of indwelling metal 
Review of medical records, 
thorough participant and 
caregiver screening before scan  
Improbable 
Other physiologic 
responses (nausea, 
headache, muscle 
stiffness) 
Emphasize hydration and 
ensuring rest before scanning 
Unlikely 
Effects on unborn 
fetus 
Pregnancy screening of females 
Improbable 
Dizziness following 
scan (orthostatic 
response to lying 
down) 
Moving from a supine to sitting 
position after completion for 1-2 
minutes, accompanying child out 
of the scanner room  
Likely 
Temporary mild 
Use of foam ear plugs to 
Unlikely 

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hearing loss due to 
scanner noise 
reduce noise intensity before 
scanning 
 
13.2 Reproduction Risks:  Both TMS and MRI have unknown risk on the fetus.  
Therefore, any pregnant women will not be allowed to participate.   
13.3 Risks to Others: For parents/guardians accompanying participants in the 
CMRR, they are subject to some of the risks associated with MRI scanning. 
Therefore, all individuals accompanying the participant will be screened 
using CMRR screening tools.  
14.0 Potential Benefits to Participants 
14.1 Potential Benefits: There may be a short-term benefit in movement function 
from a single-session of tDCS, as described in other studies.17, 18 However, 
this benefit is not expected in our participants with UCP, nor is the objective 
of the study to improve movement function or control.  
There is no direct benefit to CTD from participation in this study. We do not 
expect a single-session of tDCS to significantly alter movement function in 
these children, however improvements in motor learning have been 
demonstrated in CTD following tDCS.14 The safety of tDCS has been 
clearly demonstrated in children ages 7-21 in our previous work19 (and 
Gillick et al. In Review) and other systematic reviews.16, 20, 21 Therefore, we 
justify using CTD in our study as a scientifically-sound comparison group.   
15.0 Data Management 
15.1 Data Analysis Plan: Baseline and demographic information will be 
summarized by descriptive statistics for continuous variables, and the 
number and percentage of participants in each category for categorical 
variables. The primary analysis will compare changes in behavioral and 
neurophysiologic measures between the two intervention groups (real and 
sham tDCS). When possible, we 
will use repeated measures 
ANOVA to account for differences 
between groups. If measures are 
non-normally distributed, we will 
use Wilcoxon signed-ranks tests. 
We will use correlation analysis to 
compare modeled peak electric field 
strength with changes in behavioral 
and neurophysiologic outcomes. 
15.2 Power Analysis: With the data and literature available, we 
completed power calculations for the primary neurophysiological 
outcome, MEP, and the behavioral clinical outcome, the Assisting 
Hand Assessment (AHA) scaled score (Table 2).  These were based 
on the difference between the pre- and post-test measurements 
Summary of power analysis with alpha 
of 0.0125 and N per group of 8 
 
MEP 
Correlation 
Δ 
SD 
Power 
0.3 
0.75 
0.5 
0.71 
0.4 
0.75 
0.5 
0.75 
0.5 
0.75 
0.5 
0.81 
0.6 
0.75 
0.5 
0.87 
0.7 
0.75 
0.5 
0.94 

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adjusting for baseline values, similar to ANCOVA analyses, for 
added precision. These calculations used the sample size formula 
for normally distributed statistics with a Bonferroni corrected type I 
error level of 0.0125 for the four potential primary comparisons 
between the: 1) Anodal Ipsilesional tDCS group versus Shamc 
tDCS, 2) Cathodal Contralesional tDCS versus Shamc tDCS, 3) 
Anodal Ipsilesional tDCS group versus Cathodal Contralesional 
tDCS, and 4) Anodal Contralesional tDCS versus Shami tDCS to 
maintain an overall type I error level of 0.05. Power was computed 
for 8 participants per treatment group across a range of possible 
values for the correlation between pre- and post-treatment 
measurements. These were computed for a change in the MEP of 
0.75 mV. The mean change and standard deviation of the MEP in 
the study population was based on the tDCS/CIMT study. The 
correlation between pre- and post-treatment MEP in the 
tDCS/CIMT study was approximately 0.5. Based on these 
estimates, we will have 81% power to detect a change in the MEP 
of 0.75 mV, which translates into a large effect size (Cohen’s d = 
1.5). 
15.3 Statistical Analysis: Descriptive analyses of baseline characteristics 
and outcomes will include means and standard deviations for 
continuous variables and frequencies for categorical variables. 
Compliance and tolerance of the intervention will also be evaluated. 
Safety analyses will be primarily descriptive reporting the number 
and percentage of any adverse events and will be evaluated and 
monitored throughout the trial. 
This analysis will be conducted based on the intent-to-treat principle 
to compare the mean neurophysiologic change measured using the 
MEP from pre- to post- intervention between each tDCS stimulation 
dose group and sham tDCS adjusted for baseline neurophysiologic 
measures. Confidence intervals and p-values will be based on robust 
variance estimation. Statistical significance will be considered as 
p<0.0125. Supportive analyses may be conducted with consideration 
of adjustment for residual imbalances between treatment groups after 
randomization (e.g., gender).  The primary analysis will evaluate the 
change between pre- and post- measurements. A secondary analysis 
will evaluate the change between pre- and 30 minutes post. 
15.4 Data Integrity: See section 18.1 
16.0 Confidentiality 
16.1 Data security: Information about study subjects will be kept confidential 
and managed according to the requirements of the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA). Those regulations 
require a signed subject authorization informing the subject of the 
following: 

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• What protected health information (PHI) will be collected from subjects 
in this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research subject to revoke their authorization for use of 
their PHI. 
 
In the event that a subject revokes authorization to collect or use PHI, the 
investigator, by regulation, retains the ability to use all information 
collected prior to the revocation of subject authorization. For subjects that 
have revoked authorization to collect or use PHI, attempts should be made 
to obtain permission to collect at least vital status (i.e. that the subject is 
alive) at the end of their scheduled study period. 
 
As disclosure of PHI is an aspect of participation in this study, there is a 
potential risk of unauthorized disclosure of PHI. To prevent this risk, we 
collect and store all PHI in a locked filing cabinet located in our keypad-
controlled laboratory. Electronic PHI will be stored on HIPAA-compliant 
RedCap repositories. Pictures and other collected PHI will be stored on the 
University of Minnesota Box account, which is approved for the storage of 
PHI. No copies of the consent will be associated with the participant’s 
medical or employment record. 
 
17.0 Provisions to Monitor the Data to Ensure the Safety of 
Participants 
 
17.1 Data Integrity Monitoring. 
There will not be a designated data integrity monitor associated with 
this study. Instead, the PI will work with the study coordinator to 
ensure all data is collected, recorded, and maintained properly, and 
that regulatory and compliance procedures are followed accordingly. 
The study case report form (CRF) is the primary data collection 
instrument for the study. All data requested on the CRF must be 
recorded. All missing data must be explained. If a space on the CRF 
is left blank because the procedure was not done or the question was 
not asked, write “N/D”. If the item is not applicable to the individual 
case, write “N/A”. All entries should be printed legibly in black ink. 
If any entry error has been made, to correct such an error, draw a 
single straight line through the incorrect entry and enter the correct 
data above it. All such changes must be initialed and dated. DO NOT 
ERASE OR WHITE OUT ERRORS. For clarification of illegible or 
uncertain entries, print the clarification above the item, then initial 
and date it. 

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A Case Report Form will be completed for each participant enrolled 
into the clinical study. The investigator will review, approve and 
sign/date each completed CRF. The investigator’s signature serves 
as attestation that all clinical and laboratory data entered on the CRF 
are complete, accurate and authentic.  
The CRF shall contain at a minimum the following components: 
1) 
Eligibility documentation, Phone Screen Form 
2) 
HIPAA Form 
3) 
Demographic Medical History Form  
4) 
Individual Data Collection Forms 
5) 
Exit and Survey Forms 
Record Handling: Data for this study will be entered by the research 
investigators and study coordinator immediately into the case report 
form (CRF) for each participant. The data will then be entered into 
aa REDCap database, which uses a MySQL database via a secure 
web interface with data checks used during data entry to ensure data 
quality. REDCap includes a complete suite of features to support 
HIPAA compliance, including a full audit trail, user-based 
privileges, and integration with the institutional LDAP server. The 
MySQL database and the web server will both be housed on secure 
servers operated by the University of Minnesota Academic Health 
Center’s Information Systems group (AHC-IS). The servers are in a 
physically secure location on campus and are backed up nightly, 
with the backups stored in accordance with the AHC-IS retention 
schedule of daily, weekly, and monthly tapes retained for 1 month, 3 
months, and 6 months, respectively. Weekly backup tapes are stored 
offsite. The AHC-IS servers provide a stable, secure, well-
maintained, and high-capacity data storage environment, and both 
REDCap and MySQL are widely-used, powerful, reliable, well-
supported systems. Access to the study's data in REDCap will be 
restricted to the members of the study team by username and 
password. 
Record Keeping: All records and CRFs will be kept in the study 
coordinator’s locked file cabinet in her office until completion of the study. 
Thereafter the PI will maintain all records for 6 years. 
17.2 Data Safety Monitoring. 
Adverse Event 
An adverse event (AE) is any symptom, sign, illness or experience 
that develops or worsens in severity during the course of the study. 
Intercurrent illnesses or injuries will be regarded as adverse events. 

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Abnormal results of laboratory or diagnostic procedures are 
considered to be adverse events if the abnormality: 
• Results in study withdrawal 
• Is associated with a serious adverse event 
• Is associated with clinical signs or symptoms 
• Leads to additional treatment or to further diagnostic tests 
• Is considered by the Investigator to be of clinical significance. 
Serious Adverse Event  
A serious adverse event (SAE) is any adverse event that is: 
• Fatal 
• Life-threatening 
• Requires or prolongs a hospital stay 
• Results in persistent or significant disability or incapacity 
• A congenital anomaly or birth defect 
Important medical events are events that may not be immediately life-
threatening, but are clearly of major clinical significance and may be 
SAEs. They may jeopardize the participant, and may require 
intervention to prevent one or the other serious outcomes noted 
above.  
Individual and Entire Study Stopping Rules 
 
a. Death. Study stopped for both individual and entire trial. Full investigation 
of event explored by entire study team. The PI and Medical Director will 
review all details. An event report will be distributed to all governing and 
monitoring committees. 
b. Transient Functional Decline in Motor and/or Cognitive ability. 
i. Entire Trial: After the first half of participants are enrolled, the PI will 
perform an interim safety analysis to determine if the intervention is 
causing harm. The primary outcome will be performance on the reaching 
task. We will also consider reports of any adverse events during the 
study or that occur after participation during a follow-up phone call with 
the family/participant. If the difference between sham and real tDCS 
groups exceeds 2 standard deviations in favor of sham tDCS, the study 
will be stopped at this interim for review by the PI and medical director.  
If they deem that the protocol has indications for change due to the 
differences between means, the study will be reviewed by the 
investigative team and will be changed and submitted for re-approval by 
the IRB before recommencing the study.  
 
c. Seizure 
i. Individual: Removal of child from the study and from any remaining 
study procedures. Initiation and follow-through of safe and effective 

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seizure management. Refer to comprehensive seizure management 
outline (Appendix J) and the complete seizure observation 
documentation form (Appendix K). Provide Physician letter to 
participant. (Appendix L).  
Study Medical Director Evaluation. Recommend further evaluation to 
the child and legal guardian for evaluation by pediatric neurologist if not 
the pediatrician routinely involved in the child’s care. 
 
If participant and caregiver are willing, we will assess post-seizure status 
and potential change of status.  
 
An identification of causality and re-evaluation of treatment design will 
occur by study researchers, including consultants, medical monitor and 
physicians in order to proceed. All procedures will be assessed for strict 
adherence to all intervention steps listed in the protocol. If deviation is 
found, error will be corrected. Proceed with study. 
 
ii. Entire Study: If another participant incurs a seizure, proceed with steps 
for Individual Stopping Rules for Seizure (18.2.c.i). Study will be 
suspended at this point and thorough review by research team, medical 
director and consultants will occur in order to assess the need for 
amendment of the protocol or full stop/termination of study for future 
safety concerns.  
1. 
All research procedures will be performed by qualified 
personnel who have completed required training, including 
human subjects training. Clinical procedures will be conducted 
only by personnel who are qualified by training and licensure to 
perform the procedures.   
2. 
All personnel will comply with all related regulations and laws, 
included, but not limited to 45CFR parts 60 and 64, and HIPAA 
Privacy Regulations. Study data and information will be kept 
confidential and managed in accordance with requirements of 
HIPAA. All data (CRF) will be stored in locked offices and not 
released without participant permission.  
3. 
Participants will be rigorously screened against 
inclusion/exclusion criteria to ensure that their participation is 
safe. This screening begins at the initial discussion in the phone 
screen, continues with review of the medical record by the PI 
and Medical Director and Pediatric Neurologist on the study and 
is again repeated in-person by reviewing the screening 
documentation. 

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4. 
AEs and SAEs will be assessed and followed throughout the 
study using tools developed by our laboratory (Appendix F). 
Vital sign monitoring will occur before and after the 
information. 
5.  Participants will have contact information to enable them to 
contact study personnel easily and quickly. 
18.0 Provisions to Protect the Privacy Interests of Participants 
18.1 Protecting Privacy: Information about study participants will be kept 
confidential and managed according to the requirements of the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA). Those 
regulations require a signed participant authorization informing the 
participant of the following:  
• 
What protected health information (PHI) will be collected from 
participants in this study 
• 
Who will have access to that information and why 
• 
Who will use or disclose that information 
• 
The rights of a research participant to revoke their authorization for use 
of their PHI.  
In the event that a participant revokes authorization to collect or use PHI, 
the investigator, by regulation, retains the ability to use all information 
collected prior to the revocation of participant authorization. For participants 
that have revoked authorization to collect or use PHI, attempts should be 
made to obtain permission to collect at least vital status (i.e. that the 
participant is alive) at the end of their scheduled study period. 
For participants under the age of 18: All consent/assent procedures will be 
done with at least one parent/legal guardian present. During all study 
procedures, participants will be accompanied by at least one parent/legal 
guardian, or an authorized proxy of the parent/legal guardian (e.g. 
grandparent), which we will refer to as the caregiver. We encourage the 
caregiver to remain with the child participant for the duration of the study. 
At minimum, the caregiver must be in the same building where the study is 
being conducted.  
We will provide ample time to answer questions before enrolling in our 
study. We also will provide resources (Gillick Lab and TMS) that describe 
our study procedures to prepare children and families for their experience. 
Our experience working with children and their families has made us aware 
of the importance of gathering feedback, listening to parent’s 
questions/concerns, and adapting our procedures to best meet these needs.  
18.2 Access to Participants: Participants will be given a HIPAA Authorization 
form authorizes the research team to collect PHI once enrolled in the study. 
This form is optional and enrollment is not contingent on this form being 
completed. We do not anticipate collecting additional medical information 
after enrollment in the study.  

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19.0 Compensation for Research-Related Injury 
19.1 Compensation for Research-Related Injury: There is no compensation for 
any research-related injury. Any injury that does occur will be billed to the 
participant’s health insurance.  
19.2 Contract Language: N/A 
20.0 Consent Process 
20.1 Consent Process: 
Consenting will take place immediately prior to beginning the study 
procedures. Parents/participants will have the opportunity to review the 
consent form beforehand. Consent may also take place over video (e.g. 
FaceTime or Skype) before participating in the study. Both parents and child 
will be present on screen. Written documentation of video-based consent 
processes will be included in the CRF.  
The formal consent/assent of a participant, using the IRB-approved 
consent/assent form, must be obtained before that participant undergoes any 
study procedure. This consent form must be signed by both legal guardians 
and the assent form must be signed by the pediatric participant. The 
authorized member of the research team who obtained consent/assents will 
sign both the forms. The forms will be kept in each participant’s CRF.  
20.2 Waiver or Alteration of Consent Process: N/A 
20.3 Non-English Speaking Participants: 
For non-English speaking participants and families interested in 
participating, we will use an interpreter to orally provide information about 
the study. For the consent process, the written consent document will be 
read by an interpreter to the participant/family in their native language. A 
translated short form will also be provided in their native language.  
We will use an interpreter to accompany the participant/family during the 
study procedures to help with communication. 
20.4 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 
years of age): 
Assent will be obtained using the Assent Script (Appendix M) from all child 
participants deemed capable by the IRB (older than 7 but younger than 18 
years of age) in addition to the Informed Consent of the legal guardian in 
accordance with Federal Regulations and/or the qualifying Institutional 
Review Board (IRB). A copy of the Assent form (Appendix N) signed by 
the child and the authorized research team member obtaining assent will be 
kept in the participant’s CRF. 
Both parents/legal guardians will sign a written consent form (Appendix O) 
describing this study and be provided sufficient information for an informed 

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decision about the participation of their child in this study. The signature of 
a single parent/legal guardian will be permissible in the following situations: 
• The second parent/legal guardian is deemed legally incompetent 
• The second parent/legal guardian does not have legal custody of 
the child 
In these cases, documentation will be provided with the consent 
form.  
 
21.0 Setting 
21.1 Research Sites: Potential participant will be recruited from the following 
sources: 
• Gillick lab databases (previous and interested families) 
• Newspaper and radio/television advertisements 
• CHASA (Children’s Hemiplegic and Stroke Association) 
website 
• ClinicalTrials.gov website 
• Hemikids website  
• ResearchMatch website 
• Social media 
• Clinician referrals 
Research procedures will take place at the following centers/buildings 
on the University of Minnesota Twin Cities campus: Center for 
Magnetic Resonance Imaging (CMRR), the Clinical and Translational 
Science Institute (CTSI), and the Center for Neurobehavioral 
Development (CNBD).  
 
22.0 Multi-Site Research 
N/A 
23.0 Resources Available 
23.1 Resources Available: 
Recruitment Resources 
We are confident in our ability to recruit the intended sample from this study. 
Our current database contains over 400 families and we regularly receive 
inquiries into our current studies. In our most recent study, which completed 
two years ahead of schedule, we enrolled 20 out of 141 interested families. 

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Therefore, we intend to complete this research, once we obtain approval, in two 
years.  
 
Facilities 
The Clinical and Translational Science Institute (CTSI) at the UMN offers 
comprehensive research support for clinical investigators, from concept through 
publication. The mission of CTSI is to accelerate discoveries that will impact 
human health at the level of individuals and populations. 
 
The Non-invasive Neuromodulation Laboratory (NNL) is within the CTSI 
facility and houses our equipment and supplies. The NNL is supported by 
MnDRIVE (Minnesota’s Discovery, Research and InnoVation Economy) 
program which is a landmark partnership between the university and the state of 
Minnesota. The program of Brain Conditions includes non-invasive 
neuromodulation and supports a Non-invasive Neuromodulation Laboratory 
specifically for helping faculty members and staff conduct their 
neuromodulation related experiments. The NNL has a space of 500 square feet 
for experiments and consenting paperwork. Parking is free and easily accessible 
for participants. With equipment and facilities, the NNL is able to conduct all of 
the non-invasive TMS excitability assessment and neuromodulation paradigms 
including cortical excitability assessment (TMS using EMG and stereotactic 
neuronavigation equipment and supplies), neuromodulation interventions 
(tDCS), sensory function evaluation and customized protocol training. The 
CTSI/NNL is located one block from the University of Minnesota Medical 
Center, which offers emergency medical services in the event of an injury or 
serious adverse event during the study. 
 
The Center for Magnetic Resonance Research (CMRR) is a world-renowned, 
interdisciplinary research facility providing state-of-the-art instrumentation, 
interdisciplinary research expertise, and infrastructure to carry out biomedical 
research utilizing the unique capabilities provided by high field MRI. The 
central aim of the research conducted in CMRR is to non-invasively obtain 
functional, physiological, and biochemical information in intact biological 
systems, and use this capability to probe biological processes in health and 
disease. The Center is housed in a freestanding ~34,000 square foot facility and 
is equipped with multiple high-field magnets with field strengths ranging from 3 
to 10.5 Tesla for humans and up to 16.4 for animals. Three private rooms for 
participant screening and consultation are also available. Parking is free and 
easily accessible for participants. The CMRR is conveniently located on campus 
and available for testing 24 hours a day, 7 days a week. 
 
Located one floor above the CTSI, the Center for Neurobehavioral 
Development (CNBD 9000 sq. ft.) is an inter-disciplinary setting for 
psychological, developmental, and cognitive neuroscientists to conduct studies. 
Its mission is to engage in basic and clinical research addressing the underlying 
mechanisms of typical and atypical neurobehavioral development. Currently, 

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the CNBD supports over 35 studies investigating children’s cognitive and 
neurobehavioral functioning. The CNBD provides a family-friendly research 
environment, with free and easily accessible parking, sibling care, a caregiver 
waiting room and child playroom available to families in testing. The PI is a 
faculty member of the CNBD. 
 
 
Study personnel training 
 
 
All research team members will be trained in the Good Clinical Practice of 
conducting research, including HIPAA and Responsible Conduct of Research 
training. In addition, all members will be have completed CMRR safety training 
and lab-specific protocol training as related to TMS and tDCS procedures. For 
each study procedure, there will be present a minimum of two research team 
members.  
 
24.0 References 
 
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CL, Durkin MS et al. Prevalence of cerebral palsy, co-occurring autism 
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2. Bolognini N, Vallar G, Casati C, Latif LA, El-Nazer R, Williams J et al. 
Neurophysiological and behavioral effects of tDCS combined with 
constraint-induced movement therapy in poststroke patients. Neurorehabil 
Neural Repair 2011;25(9):819-29. 
3. Figlewski K, Blicher JU, Mortensen J, Severinsen KE, Nielsen JF, Andersen 
H. Transcranial Direct Current Stimulation Potentiates Improvements in 
Functional Ability in Patients With Chronic Stroke Receiving Constraint-
Induced Movement Therapy. Stroke 2017;48(1):229-32. 
4. Antal A, Terney D, Poreisz C, Paulus W. Towards unravelling task-related 
modulations of neuroplastic changes induced in the human motor cortex. Eur 
J Neurosci 2007;26(9):2687-91. 
5. Duque J, Hummel F, Celnik P, Murase N, Mazzocchio R, Cohen LG. 
Transcallosal inhibition in chronic subcortical stroke. Neuroimage 
2005;28(4):940-6. 
6. Murase N, Duque J, Mazzocchio R, Cohen LG. Influence of interhemispheric 
interactions on motor function in chronic stroke. Ann Neurol 
2004;55(3):400-9. 
7. Buchmann J, Gierow W, Weber S, Hoeppner J, Klauer T, Wittstock M et al. 
Modulation of transcallosally mediated motor inhibition in children with 
attention deficit hyperactivity disorder (ADHD) by medication with 
methylphenidate (MPH). Neurosci Lett 2006;405(1-2):14-8. 

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8. Zewdie E, Damji O, Ciechanski P, Seeger T, Kirton A. Contralesional 
Corticomotor Neurophysiology in Hemiparetic Children With Perinatal 
Stroke. Neurorehabil Neural Repair 2017;31(3):261-71. 
9. Kirton A, Deveber G, Gunraj C, Chen R. Cortical excitability and 
interhemispheric inhibition after subcortical pediatric stroke: plastic 
organization and effects of rTMS. Clin Neurophysiol 2010;121(11):1922-9. 
10. Collange Grecco LA, de Almeida Carvalho Duarte N, Mendonca ME, Galli 
M, Fregni F, Oliveira CS. Effects of anodal transcranial direct current 
stimulation combined with virtual reality for improving gait in children with 
spastic diparetic cerebral palsy: a pilot, randomized, controlled, double-blind, 
clinical trial. Clin Rehabil 2015;29(12):1212-23. 
11. Nitsche MA, Paulus W. Sustained excitability elevations induced by 
transcranial DC motor cortex stimulation in humans. Neurology 
2001;57(10):1899-901. 
12. Gillick BT, Krach LE, Feyma T, Rich TL, Moberg K, Thomas W et al. 
Primed low-frequency repetitive transcranial magnetic stimulation and 
constraint-induced movement therapy in pediatric hemiparesis: a randomized 
controlled trial. Dev Med Child Neurol 2014;56(1):44-52. 
13. Kirton A, Chen R, Friefeld S, Gunraj C, Pontigon AM, Deveber G. 
Contralesional repetitive transcranial magnetic stimulation for chronic 
hemiparesis in subcortical paediatric stroke: a randomised trial. Lancet 
Neurol 2008;7(6):507-13. 
14. Ciechanski P, Kirton A. Transcranial Direct-Current Stimulation Can 
Enhance Motor Learning in Children. Cereb Cortex 2017;27(5):2758-67. 
15. Kirton A, Ciechanski P, Zewdie E, Andersen J, Nettel-Aguirre A, Carlson H 
et al. Transcranial direct current stimulation for children with perinatal stroke 
and hemiparesis. Neurology 2017;88(3):259-67. 
16. Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T et al. 
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 
2016. Brain Stimul 2016;9(5):641-61. 
17. Giacobbe V, Krebs HI, Volpe BT, Pascual-Leone A, Rykman A, Zeiarati G 
et al. Transcranial direct current stimulation (tDCS) and robotic practice in 
chronic stroke: the dimension of timing. NeuroRehabilitation 2013;33(1):49-
56. 
18. Lazzari RD, Politti F, Santos CA, Dumont AJ, Rezende FL, Grecco LA et al. 
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with virtual reality training on the balance of children with cerebral palsy: a 
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20. Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R et al. 
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