Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury (ABI)
Phase: NA
Conditions: Acquired Brain Injury
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
 
 
 
 
Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired 
Brain Injury 
 
NCT03100370 
 
Version Date: 12/21/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
UNIVERSITY OF TEXAS – HOUSTON MEDICAL SCHOOL PROTOCOL 
 
PROTOCOL TITLE: Effects of Combined Spinal Direct Current Stimulation on Upper Limb 
Recovery in Acquired Brain Injury (IRB Number: HSC-MS-16-0237) 
 
2. 
BACKGROUND and SIGNIFICANCE 
Acquired brain injury (ABI) is the leading cause of neurological disability in the United States (Wolf et 
al.1999) and accounts for the poor physical health and the social dysfunction evident in survivors 
(Hankey et al. 1989). Hemiparesis due to acquired brain injury is the primary cause of disability (Bonita 
et al. 1988). Arm paresis is perceived as the primary cause of disability by individuals who have 
suffered ABI because of the limitations it creates in performing activities of daily living (ADL) (Broeks et 
al. 1999). Rehabilitation of the impaired limb is essential for improving motor function after ABI (Liepert 
1998 and 2008), yet only 31% of ABI survivors receive outpatient rehabilitation (CDC 2007). 
Therefore, effective therapy for upper-limb paresis must be addressed. Approximately 80% of all ABI 
survivors suffer from upper limb paresis and only 18% of these individuals gain full motor recovery with 
conventional treatments in the year following ABI (Wing et al. 2008). 
 
Rationale for using non-invasive spine stimulation as an add-on therapy modality for 
rehabilitation of upper-limb motor functions in ABI: Currently there is no cure for people with ABI 
having persistent arm and hand weakness. Particularly therapeutic approaches aiming to 
increase hand-movement dexterity should include the corticospinal tract (CST) as damage to 
the CST causes severe deficit in hand movements (Isa et al., 2014; Anderson et al., 2004). In 
this context, non-invasive central nervous system stimulation is a powerful method to modulate 
human brain function. It has a potential to be used as an add-on intervention to standard 
rehabilitation protocols, and have shown promising results in improving arm and hand function 
following stroke (Hesse et al., 2007; Edwards et al., 2009; Bolognini et al., 2011). Stimulation of 
primary motor cortex with high frequency repetitive transcranial magnetic stimulation (rTMS), 
another form of non-invasive brain stimulation, produced improvement in arm and hand 
functions after 5 days of treatment (Kuppuswamy et al.,2011; Belci et al.,2000). Researchers 
have hypothesized that increasing excitability of the primary motor cortex would modify 
descending corticospinal influences and increase inhibitory input, thus leading to more 
coordinated and skilled movements (Duque et al., 2003) with reduced spasticity. Moreover 
consecutive facilitation of components of the motor system at spinal level (spinal tract axons 
and spinal reflex pathways above injury) may have a potential to further augment therapeutic 
effects when combined with peripheral repetitive training. 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
Rationale for exoskeleton-assisted training of arm and wrist movements: There is evidence that 
treatment intensity has a profound effect on motor recovery and the use of robotic exoskeleton 
devices has potential to automate labor-intensive therapy procedures (Backhus et al., 2010; 
Sanchez et al., 2006). In this context, rehabilitative robotic exoskeleton devices can deliver high- 
dosage, high-intensity repetitive training of single joint movements or functional tasks by 
coordinated multi joint movements and can provide immediate feedback about performance. 
Our research team at NeuroRecovery Research Center at TIRR /Memorial Hermann, 
demonstrated that robotic exoskeleton- assisted training can provide positive gains in arm and 
hand functions in neural recovery (Yozbatiran et al., 2011; Kadivar et al., 2011). These 
observations have been supported by others (Zarrifa et al., 2011; Cortes et al., 2013). 
 
3. 
PURPOSE OF THE STUDY: 
 
The purposes of this project are: a) to evaluate if adults with chronic acquired brain injury can 
improve their upper-limb voluntary movement by participating in a therapeutic program that 
combines non-invasive spine stimulation with exoskeleton-assisted training (E-A training) to 
investigate neuroanatomical and neurophysiological mechanisms of therapeutic improvement. 
Our preliminary data and the literature support the model that augmentation of activity in spared 
corticospinal tract (CST) axons is a critical mechanism of motor improvement, and furthermore 
that CST activity can be increased by repetitive motor training and by electrical stimulation of 
the cervical spinal cord. Therefore, our project will address the goals of providing a direct, 
beneficial impact to persons with acquired brain injury while, at the same time, investigating the 
mechanisms that result in improved function. 
 
4. 
DESCRIPTION OF STUDY: 
 
Fifteen patients with weakness on one side of the body due to stroke ABI will receive ten 
sessions combined treatment of 20 minutes of 2.5 mA anodal, cathodal, and sham tsDCS over 
cervical spine combined with high intensity exoskeleton-assisted arm training, five days a week, 
for 2 consecutive weeks. 
 
The study will use cross-over, randomized, sham controlled, double-blinded design in which 15 
participants with subacute or chronic ABI will be assigned to receive either active anodal spinal 
stimulation, cathodal spinal stimulation, and sham spinal stimulation experiments for the same 
duration in a random order. In all the experiments participants will receive exoskeleton-assisted 
training for duration of 1.5 hours. The first 20 minutes of training will be coupled with spinal 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
stimulation. Treatment will be administered at an intensity of 5 sessions per week for 2 weeks 
(Please see study HSC-MS-15-0269 PI: Dr. Yozbatiran). 
Pre-screening Procedures: During the pre-screening process, potential subjects with ABI will be 
contacted by phone from research personnel. The aim and details of the study will be explained 
in details (reading from a phone script) and information such as demographics, medical history, 
medications being used, etc. will be gathered. Also ABI subjects will be screened for tsDCS and 
transcranial magnetic stimulation (TMS) contraindications (attachment 1, attachment 2) and a 
subgroup of patients (n=5) will be screened for MRI contraindications (attachment 3). The pre- 
screening will last about 30 minutes and will be performed in a private area. Once this 
information is collected, the coordinator will consult with the Drs. Francisco (PI) and Dr. 
Yozbatiran and they will give final approval for the subject to come to The Institute for 
Rehabilitation and Research Memorial Hermann for the screening procedure. 
Screening (Visit 1, duration: One hour): After subject arrives at TIRR a research personnel will 
meet him/her at the Motor Recovery Laboratory. The details of the study-specific procedures will 
be reviewed with the subject together. Subject will be screened for inclusion and exclusion 
criteria. Signed and dated informed consent will be obtained. Demographics, medical history, list 
of medications will be recorded. If the subject is female in child bearing ages, a urine pregnancy 
test will be requested. A medication diary will be given to the subject and asked to document all 
changes in type and dosage of the medication he/she has been using throughout the study. 
This will allow us to differentiate a potential effect of a change in dosage or type of medication 
on movement recovery. After subject meets all Inclusion an Exclusion Criteria he/she will be 
randomly assigned to active, cathodal or sham tsDCS group. 
 
Baseline Assessment (Visit 2, duration: three to four hours): The baseline assessment can be 
on the same visit as screening and will be performed in the Motor Recovery Laboratory by an 
evaluator blinded to subject’s group assignment. Subjects will be evaluated for upper extremity 
motor functions. Primary clinical outcome measure is Fugl-Meyer Assessment (FMA). 
Secondary clinical outcome measures will be Jebsen Taylor Hand Function Test (JTHFT), box 
and block test Modified Ashworth Scale (MAS by Bohannon &Smith 1987), Motor Activity Log 
(MAL), and neurophysiologic testing for spinal conductivity (SSEP), spinal reflexes and 
exoskeleton measurements for movement quality. Patients who are eligible also will undergo 
neurophysiological and neuroimaging testing with transcranial magnetic stimulation and one- 
hour MRI scan. 
 
Neurophysiological testing: Transcranial Magnetic Stimulation (TMS) uses electromagnetic 
induction to induce weak electric currents using a rapidly changing magnetic field. Single pulse 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
TMS causes neurons in the cortex under stimulation site to depolarize and discharge an action 
potential. In the current study we will use single pulse TMS for recording neurophysiological 
changes of corticospinal tract after treatment in comparison to baseline and at follow-up visits. 
Single pulse TMS will be applied over corresponding motor cortex and motor threshold (MT) will 
be determined. Single pulse TMS has been reported as safe. However subjects may 
experience; headache or neck pain which may occur due to extra muscle tension and from the 
straight posture of the head and neck during the application of TMS and ringing in the ear and 
due to loud clicking sound. In order to mitigate the aforementioned side effects, people will be 
asked to wear earplugs and will be offered acetaminophen or aspirin for pain. Recording motor 
evoked potentials: In order to record the muscle activity caused by the stimulation of movement 
related brain tissue, small surface electrodes will be placed on hand and forearm. 
Somatosensory evoked potentials (SSEP): to assess the conduction in the somatosensory 
pathway electrical stimulation will be applied over arm median nerve. Procedure will follow per 
clinical protocol. 
Spinal reflexes: Spinal reflexes (H-reflex, M-wave and F-wave): the responses are initiated by 
passing an electrical current through a mixed nerve that includes both muscle spindle afferents 
and motor efferents of the test muscle. To elicit this response in an arm muscle, the electrical 
stimulus will be passed through the median nerve (or radial, ulnar nerve). For this procedure 
surface electrodes will be used, and stimulating and recording electrodes will be placed over the 
forearm. 
Electrophysiological testing: Electroencephalography (EEG) will be recorded to measure the 
electrical activity in the brain and to examine changes in cortical dynamics during tDCS 
combined with exoskeleton-assisted arm training. It allows for better understanding of the 
effects of electrical activity generated in different areas of the brain associated with tDCS and 
combined motor training. EEG only measures brain activity and does not induce electrical 
current in the brain. It is non-invasive and has been used extensively in clinical practice for 
diagnosis or neurological conditions such as epilepsy. There are no risks associated with EEG 
other than a mild discomfort caused by the tightness of the cap. The investigator will adjust the 
cap to allow for the comfort of the subject. 
Neuroimaging: For persons who qualify for undergoing neuroimaging, structural and functional 
MRI is performed to understand the reorganization of cortical areas associated with motor 
recovery. Morphological changes (structural plasticity) will be measured with structural MRI by 
using diffusion tendon imaging techniques. MRI is noninvasive and has been used extensively 
in clinical studies. In order to eliminate the risks associated with magnetic field, subjects will be 
scanned for MRI safety. 
Functional near-infrared spectroscopy (fNIRS) device will be used to measure and record to 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
relative changes in oxygenated and deoxygenated hemoglobin from the motor cortex of the 
brain. This in turn will help examine and understand the effects of a combined 
tsDCS/exoskeleton- assisted arm training treatment upon motor-related brain activity. FNIRS 
emits near-infrared light (740nm/850nm) into the head and acquires the amount of light 
returning using a detector positioned 3cm from the light source. It is a portable, non-invasive 
device similar to EEG and has been used in multiple research studies investigating brain 
function under various task-oriented settings. One major risk the fNIRS device poses is potential 
eye damage if the infrared light-emitting diodes (IR LEDs) are shined into an individual’s eyes 
for an extended amount of time. This will be mitigated however by ensuring that the investigator 
leaves the device powered off before placing it on the user’s head. An additional minor risk 
includes a mild discomfort caused by the tightness of the headband and straps. The investigator 
will adjust the device to provide optimal comfort to the subject. 
 
Intervention Period (Visit 3-12, duration: one and a half hours per visit): Within one-week 
following the baseline visit, subjects will receive; 1) active, 2) cathodal or 3) sham tsDCS along 
with exoskeleton arm training daily (Monday-Friday) for weekdays for over two-weeks. 
Stimulation will last a total of 20 minutes along with exoskeleton-training will continue for 
another 75 minutes. 
For spinal stimulation direct current will be delivered by a battery-driven direct current stimulator 
(Soterix Medical, Model 0707-A) connected to a pair of saline-soaked sponge electrodes 
(7x5cm, 35cm²). 
tsDCS: tsDCS active electrode will be placed on the midline of the posterior part of the cervico- 
thoracal vertebraes, and the neutral electrode will be placed over the shoulder. The stimulus 
intensity will be set at 2.5 mA and applied over a 20 min period (Cogiamanian et al., 2008; 
Winkler et al., 2010; Lamy et al., 2012) resulting in a current density of 0.071 mA/cm2 and a 
delivered total charge of 64 mC/ cm2. The current will be ramped up to 2.5 mA over a -30 s 
period and similarly ramped down at the end of stimulation. 
Exoskeleton-assisted training: The side being trained (right vs left arm) will be weaker side of 
the body. Treatment will be provided by Dr.Yozbatiran, in a dedicated therapy area in the 
UTHealth Motor Recovery Lab at TIRR-Memorial Hermann. Subjects will individually perform 
upper-extremity therapy exercises that are supported by the exoskeleton device. Activities that 
the subjects will be asked to perform will be selected based on the subject’s upper-extremity 
motor function, including elbow flexion-extension, forearm pronation-supination, wrist flexion- 
extension, and radial-ulnar deviation. The tasks will be repeated multiple times per session for 
improved performance. Graphic feedback about performance will be given after each attempt in 
order to maintain motivation. Rest breaks will be given in order to avoid fatigue. 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
fNIRS: to measure brain activity over the treatment duration at the beginning of each session 
fNIRS system will be placed over the head of the subject. Brain activity will be recorded during 
rest (no active movement with the hand) and during movement (performing a motor task with 
hand). 
 
Safety Assessment: 
Questionnaire: At the end of each therapy session, tsDCS side effects questionnaire will be 
used to monitor any adverse events and study adherence (attachment 3). At the end of each 
session, the subject will describe any sensations they felt during stimulation and if they feel 
anything unexpected happened during the study visit. In addition the subject will be asked to 
rate his/her level of fatigue, pain, and satisfaction with the activities during the session. 
Tolerability Assessment: Participants will be asked to rate the cervical spine unpleasantness 
and discomfort with a subject scale defining the level from “no discomfort at all” to “unbearable 
discomfort”. 
Post-treatment and Follow-Up Assessment (Visit 13-15, duration: one and a half hours): During 
this period subjects will be asked to come within a-week after they have completed the study, at 
week-1 and month-1. Month-1 assessment will serve as the baseline assessment of the next 
treatment arm. Motor functions tests, exoskeleton measures and neurophysiological 
measurements with SSEP, TMS and fNIRS will be repeated after the treatment, at 1-week and 
at 3- months follow-up visits. MRI scan will be performed before and after treatment only. 
Portion of assessment sessions will be videotaped and/or photographed. Subjects will be asked 
to move or manipulate some objects with the arm while a project staff member will record or 
photograph. Subjects’ consent will be required to perform and photography or videotaping. 
Screening, assessment and treatment sessions will be held at the UTHealth Motor Recovery 
Laboratory at The Institute for Rehabilitation and Research and at UTHealth Medical School, 
MRI Facility. A total of up to 42 visits are required. Each visit will take about one-and-a-half 
hour. Schedule of assessments is shown in Table 1. 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
Table 1. Schedule of assessments for adults with ABI for the first arm of the design. The 
subjects will undergo same study schedule in second and third treatment arms (See figure 1). 
 
Assessment 
Screening 
Baseline 
Assessment 
Intervention period 
Post-treatment 
Assessment 
Follow-Up 
Assessment 
at 1- week 
Follow-Up 
Assessment 
at 1- Months 
Day7- to 
Day1 
Day 1 
Day 4(±3) to Day 15(±3) 
Day 19(±3) 
Day 26 (±4) 
Day 45 (±5) 
Visit 1 
Visit 2 
Visit 3-12 
Visit 13 
Visit 14 
Visit 15 
ICF 
X 
I/E Criteria 
X 
X 
Randomization 
X 
Demographics 
X 
X 
Medical History 
X 
X 
ASIA (motor and sensory 
score) 
X 
X 
X 
X 
Modified Ashworth Scale 
X 
X 
X 
X 
NHPT 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Motor Activity Log 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Grip Strength 
X 
X 
X 
X 
Pinch Strength 
X 
X 
X 
X 
JTHFT 
X 
X 
X 
X 
FMA 
X 
X 
X 
X 
Exoskeleton 
Measurement 
X 
X 
X 
X 
tsDCS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
tsDCS related side 
effects 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
MRI Scan 
X 
X 
TMS 
X 
X 
X 
X 
SSEP 
X 
X 
X 
X 
EEG 
X 
X 
X 
X 
Spinal reflex 
X 
X 
X 
X 
fNRIS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
 
 
 
Figure 1. The cross-over design of the study is illustrated. Abbreviations: Post-tx=Post- 
treatment assessment, EAAT= Exoskeleton -assisted arm training, tsDCS=transcutaneous 
spinal direct current stimulation, 1 w f/u= 1 week follow-up after the study intervention, 1 m f/u=1 
month follow-up assessment after the study intervention. 
 
Specimens to be collected, including frequency and size/amount: 
None. 
 
5. 
SUBJECT POPULATION: 
Fifteen adults with acquired brain injury (ABI) will be recruited from TIRR Memorial Hermann, 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
TIRR Outpatient Rehabilitation at Kirby Glen and from the Houston area. 
 
Inclusion Criteria: 
1. Providing written informed consent prior to any study related procedures; 
2. Age above 18; 
3. Diagnosis of acquired brain injury at least for 6 month 
4. No neuropsychiatric comorbidities 
5. Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 
months; 
6. No planned alteration in upper-extremity therapy or medication for muscle tone during the 
course of the study; 
7. Eligibility for standard upper-extremity rehabilitation at the time of enrollment (i.e., absence 
medical comorbidities that would prevent standard rehabilitation); 
8. No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid 
administration of the measures or with interpreting motor testing; 
9. No contraindications to tsDCS: 
- 
metal in the head between stimulation area 
- 
metal in the spine between stimulation area 
- 
implanted brain medical devices 
10. No pregnancy; 
11. No contraindications for TMS and MRI based on TMS and MRI screening forms 
 
Exclusion Criteria: Subjects will be excluded if they have: 
1. Uncontrolled epilepsy; 
2. Any joint contracture or severe spasticity in the affected upper extremity, as measured by a 
Modified Ashworth Score > than 3 out of 4; 
3. History of substance abuse; 
4. Subject who cannot provide self-transportation to the study location. 
 
 
 
 
6. 
SUBJECT ENROLLMENT: 
 
Potential subjects will be identified by the following sources: 
 
1- Flyers will be posted in the TIRR Memorial Hermann outpatient clinic, TIRR Memorial 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
Herman Adult and Pediatric Outpatient Rehabilitation Kirby Glen, MHH Rehabilitation Centers. 
Attending physicians and therapists may refer their acquired brain injury outpatients to the 
study. In order to reach out to individuals with ABI; flyers will be distributed through an e-mail 
distribution, through social media such as Facebook and LinkedIn and twitter. 
2- After subjects are identified by their treating physicians and therapists, they will be referred to 
the co-investigator. During this first contact, the researcher will briefly explain the study content 
and request their phone number and e-mail address to contact them later for a pre-screening. 
During a phone call, a brief pre-screening procedure will be applied. Demographics and medical 
information such as surgery implants, medications, psychiatric, drug and alcohol history as 
inclusion and exclusion criteria will be gathered. Drs. Francisco and Yozbatiran will review the 
information gathered during phone screening and may request more information about the 
surgery such as type of surgical implants, previous MRI notes, etc. In our experience with 
previous projects, we always needed to collect information from patients’ medical record before 
the person could be enrolled into the study. For example if a surgery had been performed an 
approval from surgeon’s office was requested to confirm the compatibility of surgical 
instruments with 3Tesla MRI. In some circumstances we further confirmed the surgical implants’ 
compatibility with the manufacturing company. After all information are gathered Drs.Francisco 
and Yozbatiran will agree or decline subject’s enrollment into the study. A copy of consent form 
will be e-mailed to subject. 
3- Potential subjects will be invited to come for a screening visit to Motor Recovery Laboratory 
at TIRR Memorial Hermann. Any information gathered during phone screening will be stored in 
a locked file cabinet and password protected electronic file. During the screening visit, an 
investigator at TIRR will obtain informed consent. The test procedures will be described and the 
testing equipment will be shown to the subject. A co-investigator will clearly explain all the 
procedures and risks of the testing outlined in the consent form. The subject will be given 
sufficient time to consider their decision and will be encouraged to ask questions, both during 
the initial interview and throughout the study. The PI or a co-investigator will answer any 
questions regarding the study at the time consent is given. Once enrolled, the subject may 
pause or terminate his/her participation at any time during the study. 
4- Alternatively any person with ABI who are living in the community and been informed through 
flyers can contact the researchers directly and request more information about the study. 
 
 
7. 
DATA ANALYSIS: 
Data analysis: Analyses will be performed with two-tailed significance tests at the 95% 
confidence level and are planned using parametric methods with continuous variables. 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
However, before performing parametric analyses we will examine the data for evidence of 
assumption violations and, if such violations are serious, we will perform data transformations or 
use non-parametric methods as appropriate. Four comparisons will be made. The primary 
efficacy variable will be the change in hand functions as measured with Jebsen-Taylor Hand 
Function test. Secondary outcome measures include change in strength of selective muscle 
groups, change in movement function and number of subjects who will reach minimally clinical 
significant change (ARAT), and muscle tonus (Modified Ashworth Scale) and change in 
movement smoothness (exoskeleton measurements), and change in the neurophysiological 
responses of central nervous system (TMS, SSEP). Adverse effects will be monitored with a 
Side Effects Questionnaire. 
Within subject comparison of after treatment vs. baseline will be performed, separately for each 
group, using paired t-test. Second, a between groups will examine the effects of treatment by 
using a repeated measures of ANOVA to test for a time x group interaction. Third subjects’ 
ratings of pain and fatigue after each therapy session will be compared the pain and fatigue 
ratings, to determine if there was unacceptable to subjects. 
The level of significance used will be p<0.05. 
Analysis for Neuroimaging scans: Biological correlates of the tsDCS and training will be 
obtained by computing white matter fiber integrity measures of the CST using diffusion tensor 
imaging an analysis in AFNI (Cox, 1996) and DTI Query (Sherbondy et al, 2005). Integrity 
measures will include fiber tract density, strength, and their interaction (Ellmore et al 2011), as 
well as a comparison of parallel and perpendicular diffusivities to investigate changes in axonal 
integrity and myelination, respectively. We specifically predict that tsDCS combined with 
repetitive training will result in increased white matter integrity, including increased fractional 
anisotropy, increased tract density, and changes in axial and radial diffusivities that are 
consistent with improved myelination and axonal coherence. 
 
Cortical activity assessment with electroencephalogram (EEG): EEG activity will be assessed in 
all participants using standardized procedures during baseline, during each training session, 
and after training in the follow-up sessions. EEG will be sampled with up to 64 electrodes using 
an electrode cap, which places the electrodes in the standard 10-20 international placement 
system (Electro-Cap International, Inc). Ground electrode is built into the cap and will be at site 
AFZ. In this context, neuroplastic changes in oscillatory cortical dynamics were shown to outlast 
motor cortical tDCS for up to 25 minutes, particularly in a fronto-parietal network 
(Venkatakrishnan et al., 2011). Therefore, in order to characterize and track neuroplasticity 
associated with tDCS combined exoskeleton training, here changes in cortical network 
properties (E.g., functional connectivity estimated using granger causality etc.) will be 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
investigated using a data-driven approaches (e.g., graph theoretical approaches) and 
contrasted/compared with hypothesis-driven methods (Chen et al., 2011, Venkatakrishnan & 
Sandrini, 2012). 
 
8. 
POTENTIAL RISKS/DISCOMFORTS: 
 
tsDCS: Transcutaneous Spinal Direct Current Stimulation (tsDCS) is a noninvasive procedure 
in which a device sends a small Direct Current (DC) across the skin to modulate spinal function. 
The use of tDCS in therapeutic protocols to date has not resulted in severe adverse effects. In 
addition our protocol of 2.5mA has been used by other researchers with no signficant adverse 
events (Meyer-Friessem et al., 2015; Bocci et al., 2014). 
Transcranial Magnetic Stimulation (TMS): According to published studies, single pulse and 
paired-pulse TMS is both safe and useful for investigating the neurophysiological aspects of 
human health and disease. Although rare with single pulse TMS compared to repetitive TMS, 
discomfort or pain from the stimulation of the scalp and associated nerves and muscles on the 
overlying skin may occur. In addition TMS coil produces a loud clicking sound that increases 
with the stimulation intensity. We will use earplugs to reduce the sound from the coil. If subject 
presents any contraindication to TMS application, he/she will not be exposed to TMS. 
Magnetic Resonance Imaging (MRI): The structural MRI is performed to measure the 
structural connectivity of the corticospinal tract. MRI is noninvasive and has been used 
extensively in clinical studies. In order to eliminate the risks associated with magnetic field, only 
subjects from each group with no contraindication to MRI will be scanned, and only subjects 
who pass MRI screening will be invited to undergo MRI. All scanning sessions will be 
supervised by Dr.Yozbatiran. 
Electromyography (EMG): The EMG, involves testing of the muscle activity through electrical 
signals. In the current project, it will allow to record motor evoked potentials. It is non-invasive 
and non-painful to the subject and has been used widely in clinical or research settings. The 
risks associated with surface EMG is some skin irritation. 
SSEP: Somatosensory evoked potential is recording electrical signals of sensation going from 
body to brain. Recording electrodes are attached to the scalp and arm. The stimulus will last 
about 2 minutes at a time and may cause some twitching and tingling sensation in the target 
area. However it is painless and carries no significant risk. 
Spinal reflexes measurement: Stimuli above the action threshold of peripheral nerves will be 
administered through skin. This might cause some discomfort that is anticipated to be mild and 
easily tolerated by the subjects. Also skin irritation might occur due to electrode attachment to 
the skin. 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
 
EEG: An electroencephalogram (EEG) is a test that detects electrical activity in the brain using 
small, flat metal discs (electrodes) attached to your scalp. This activity shows up as wavy lines 
on an EEG recording. Like in EMG, the main risk associated with it is skin irritation. 
 
fNIRS: Prototypes analogous to the Axem Home prototype to be used in the present study have 
been utilized in four previous REB-approved studies (Dalhousie REB# 2017-4267, National 
Research Council REB# 2018-107, Dalhousie REB# 2019-4762, Veritas IRB# 16439- 
11:51:2730-09-2019), with no reported adverse events. fNIRS is generally regarded as a non- 
invasive method of brain activity measurement given that the risks associated with it are minor. 
fNIRS involves the emission of non-ionizing radiation (light at 740 and 850nm respectively) into 
the skull. The amount of radiation being emitted from the Axem Home prototype is within the 
exempt risk category for skin exposure according to IEC 62471 (Photobiological safety of lamps 
and lamp systems) section 4.3.8, and thus does not impose any risk. However, the participant 
will be told that they should report any discomfort on their head, whether it is from feelings of 
warmth, or discomfort with the fit of the prototype on their head. However, given that the light 
output from the Axem Home prototype is not in the exempt risk category for retinal exposure 
(IEC 62471 section 4.3.7), in the present study the device will only be powered on once it is 
secured on the head, with the chin strap in place; and moreover, the device will be powered off 
prior to its removal by the experimenter. 
Moreover, the electrical architecture of the device is such that firmware on the device’s 
microcontroller directly controls the current (and thereby the power output) supplied to the 
LEDs. Further safeguards are in place on the circuit board itself, as resistors on the board 
physically limit the potential maximum current (and thereby power output) supplied to the LEDs. 
And finally, the system overall is equipped with a resettable fuse that stops it from drawing more 
current than it is intended to and utilizes a certified battery pack as well as protection circuitry 
prevent any damage from occurring to the battery. 
All materials used in this experiment will comply with biocompatibility standards (ISO 10993), 
and both the surface model and the Axem Home prototype will be wiped with alcohol pads 
following each use. 
 
Exoskeleton-training: Patients with acquired brain injury sometimes develop pain or 
discomfort in the shoulders and arm. In an ongoing study in our laboratory with subjects who are 
undergoing robotic-exoskeleton exoskeleton training for three- hours per session and three- 
sessions per week for four weeks, didn’t show any significant fatigue, discomfort or pain lasting 
longer than 24 hours after training (Yozbatiran et al, 2012). If there is evidence that pain or 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
fatigue is worsened by the therapy, the sessions will be reduced or discontinued. All therapy 
sessions will be supervised by a project staff member. Assessment/Questionnaires: All 
assessments will be performed in a designated room inside Motor Recovery Laboratory. None of 
these tests are either painful or uncomfortable to perform. In order to prevent potential 
embarrassment during the testing the test will be done individually and in private. If subjects feel 
uncomfortable in answering any of the questions they may stop the study at any time. 
 
9. 
POTENTIAL BENEFITS: 
As with any study focusing on basic research, the subjects will derive no direct benefit. The 
results of these studies may benefit subsequent future subjects if combined spinal stimulation 
with repetitive training via a exoskeleton device proves to be effective when compared to 
cortical stimulation with repetitive training. We envision that in the near future the information 
obtained from the proposed research will provide a better understanding for treatment options of 
upper extremity motor function in acquired brain injury. 

IRB NUMBER: HSC-MS-16-0237 
IRB APPROVAL DATE: 12/21/2021 
 
The benefits of participating in this study may be improved arm and hand movement. However, 
there may be no benefit from participating in this study. 
 
10. 
RISK-BENEFIT RATIO: 
The potential improvement of arm and hand movement outweighs the risk of non-invasive spine 
stimulation, fatigue, pain and discomfort. 
 
11. 
CONSENT PROCEDURES: 
Informed consent will be obtained from the subject at Motor Recovery Laboratory at The 
Institute for Rehabilitation and Research. After the patient is identified by the PI and her 
research team study criteria and he/she is interested in participating, informed, written consent 
will be obtained by a member of the research team. 
In addition a photography/videotaping consent will be obtained from the subject, if he/she 
agrees to be photographed / videotaped during the assessments or treatment sessions. 
 
12. 
CONFIDENTIALITY PROCEDURE: 
All data will be coded with identification number, database will be in a password –protected 
computer and kept in a locked file cabinet. 
 
13. 
COSTS 
The subject will not be expected to pay any costs. 
 
14. 
PAYMENTS: 
Subjects who travel to the study appointments will be reimbursed $20 for per screening, 
assessment and treatment visit in order to pay for parking and travel. Subjects who will undergo 
MRI scan will receive additional $50 for reimbursement upon completion of all scans. 
 
 
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