Feasibility and Effectiveness of Home-based Telerehabilitation Program for Recovery of Upper Limb Functions in Incomplete Spinal Cord Injury
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-MS-21-0114 
IRB APPROVAL DATE: 03/15/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Feasibility and Effectiveness of Home-based Telerehabilitation Program for Recovery of 
Upper Limb Functions in Incomplete Spinal Cord Injury 
 
NCT04977037 
 
Version Date: 03/15/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRB NUMBER: HSC-MS-21-0114 
IRB APPROVAL DATE: 03/15/2022 
 
 
Project Title: Feasibility and Effectiveness of Home-based Telerehabilitation 
Program for Recovery of Upper Limb Functions in Incomplete Spinal Cord Injury 
 
Lead Principal Investigator: Nuray Yozbatiran, PhD, Department of Physical Medicine and 
Rehabilitation, McGovern Medical School, UTHealth 
 
Co-Investigators: Xu Zhang, PhD, Department of Internal Medicine, McGovern Medical 
School, UTHealth 
 
Population: Male and female adults (>18 years of age) with cervical spinal cord injury 
 
Study Site: UTHealth, Department of Physical Medicine and Rehabilitation NeuroRecovery 
Research Center at TIRR Memorial Hermann 
 
Study Duration: 2 years 
 
Subject Duration: Approximately 2-months per subject 
 
 
1. 
Purpose: 
The overall purpose of this project is to evaluate a telerehabilitation project that uses remotely 
supervised, home-based therapeutic program to improve upper-limb voluntary movement in 
adults with tetraplegia caused by incomplete spinal cord injury (iSCI). 
 
2. 
Background 
Spinal Cord Injury affects 2.5 million individuals worldwide and often leads to severe disability 
duo to functional limitations in the sensory and motor systems. In 2020, number of new cases 
are reported as 17,810 each year and total number of individuals living with SCI were ranging 
between 250,000-368,000 (Center 2020) For those that survive the injury, the damaging effects 
not only impact the individual but there is also significant burden to family members. Many 
people with cervical SCI have limited mobility in lower and upper limb functions and require 
assistance in feeding, grooming, bathing, dressing and toileting (Kloosterman, Snoek et al. 
2009, Rudhe and van Hedel 2009). Rehabilitation programs aims to improve patients physically, 
cognitively, emotionally and in terms of social wellbeing. However, many patients are inactive 
and access to rehabilitation services are often limited due to lack of energy, reduced mobility, 
transportation costs, service costs and/or restricted availability (Cowan, Nash et al. 2013, 
Chamberlain, Meier et al. 2015, Hamilton, Driver et al. 2017, Maher, McMillan et al. 2017, Borg, 
Foster et al. 2020). 
With growing financial constraints on healthcare systems, alternative cost-effective and efficient 
methods of rehabilitation are needed. In the past decade, development of new technologies has 
paved the way for their use for clinical purposes, especially to enhance patient’s access to 
specialized treatment services. In this context, telerehabilitation has emerged to be an 
alternative to in-clinic services. Telerehabilitation is the delivery of rehabilitation services via 
communication technologies, and has the potential to manage multiple components of health 
including functional independence, self-care, and self-management (Brennan, Mawson et al. 
2009, Dorsey and Topol 2016, Richmond, Peterson et al. 2017). The use of telerehabilitation in 
spinal cord injury is emerging, however there is still lack of information on feasibility and 
effectiveness of specialized rehabilitation programs aiming to improve upper-limb motor 
functions in adults with tetraplegia. 

IRB NUMBER: HSC-MS-21-0114 
IRB APPROVAL DATE: 03/15/2022 
 
Currently there is no cure for people with SCI. Moreover, for many years SCI has been 
considered irreversible. 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). Recruitment of motor 
descending pathways via non-invasive stimulation of motor cortex might reinforce neuroplastic 
mechanisms (Martin 2016) and enhance motor recovery (Bunday and Perez 2012). In this 
context, transcranial direct current stimulation of cortical neurons may be a promising non- 
invasive technique to facilitate motor recovery. Our preliminary findings and literature has 
shown that is safe and effective as an add-on intervention to standard rehabilitation protocols in 
recovery of upper limb motor functions ((Yozbatiran, Keser et al. 2016, Cortes, Medeiros et al. 
2017, Yozbatiran, Keser et al. 2017, de Araujo, Ribeiro et al. 2020) 
 
There is evidence that treatment intensity has a profound effect on motor recovery. High- 
dosage, high-intensity repetitive training of arm movements or functional tasks can provide 
better functional outcome (Whiteneck, Gassaway et al. 2011, Backus, Gassaway et al. 2013, 
Jones, Evans et al. 2014, Brazg, Fahey et al. 2017, Francisco, Yozbatiran et al. 2017, Wouda, 
Lundgaard et al. 2018) However, many patients do not receive high doses of rehabilitation 
therapy for reasons that include cost, difficulty traveling to the location where the therapy is 
provided, shortage of regional rehabilitation care, and poor adherence with assignments. 
Furthermore, even when patients can access in-clinic rehabilitation therapy, the amount of 
therapy provided is limited, averaging 32 arm movements per session (Lang, Macdonald et al. 
2009). In this regard, through telerehabilitation systems clinicians have the possibility of 
delivering long rehabilitation trainings at patient’s homes. 
 
In summary current options for treatment of upper extremity functions in persons with tetraplegia 
have been limited to in-clinic therapy programs. We suggest that alternative delivery of 
rehabilitation services should be investigated to provide therapy. Therefore, in the proposed 
study we aim to investigate the feasibility and clinical effectiveness of remotely-supervised 
home-based telerehabilitation protocol aiming to improve arm and hand functions in adults with 
tetraplegia. 
 
3. 
Objectives: 
Specific Aim 1: to determine feasibility and adherence of remotely-supervised home-based 
upper-limb telerehabilitation program 
Specific Aim 2: to determine functional activity level in changes of measurements of upper-limb 
motor function, grip strength and health-related quality of life. 
 
4. 
Study Design: 
The proposed study will use parallel-groups, randomized, sham controlled, double-blinded 
design in which 36 participants with motor incomplete SCI (AIS B – D level) will randomly 
assigned to receive tDCS combined with repetitive arm training (RAT) or sham tDCS combined 
with R-A training. During the first 20-minute participants (n=24) in the experimental group will 
receive 20 minutes of anodal tDCS (2 mA) on motor cortex contralateral to their trained side 
followed by RAT for 60 minutes. Participants (n=12) in the control group will receive 20 minutes 
of sham tDCS followed by RAT for 60 minutes. In the sham stimulation 2 mA of anodal current 
will be delivered in a ramp up and down fashion for 30 seconds at the beginning and 30 
seconds at the end of 20 minutes of stimulation. Treatment will be administered at an intensity 
of 5 sessions per week for 2 weeks. 
The randomization schedule will be provided by project statistician (Dr. Xu Zhang). 

IRB NUMBER: HSC-MS-21-0114 
IRB APPROVAL DATE: 03/15/2022 
 
Outcome measure: 
 
Feasibility outcome measure: Adherence with therapy will be measured as; 
(1) the number of treatment sessions attended by each participant, 
(2) number of drop-outs in each group, 
(3) participant’s perceptions of the use of study implementation (using the tDCS and exercise 
equipment, numerical rating scale with ‘not difficult at all’ at 0, and ‘very difficult’ at 10) 
(4) participant’s perceptions of usefulness of the intervention (numerical rating scale with ‘not at 
all useful’ at 0 and ‘very useful’ at 10). 
 
The telerehabilitation intervention will be considered as feasible if at least 80% adherence rate 
is achieved (completed number of sessions ≥ 8 out of 10), if attrition rate is no higher than 10% 
in each study group, if at least 40 minutes of 60 minutes exercise session is completed and if no 
serious adverse events took place (other than expected side effects from tDCS). 
 
Clinical outcome measure: Primary clinical outcome measure is GRASSP prehension 
performance (Kalsi-Ryan et al., 2012). Secondary clinical outcome measures are grip strength 
and Spinal Cord Injury Independence Measure (SCIM III) (Itzkovich, Gelernter et al. 2007). 
Assessments will be repeated immediately after completion of 10 sessions and at 4-weeks 
follow-up. 
 
Brain motor cortex function: Functional near-infrared spectroscopy (fNIRS) device will be used 
to measure and record to 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 tDCS/robotic 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. fNIRS will be performed at the 
baseline, immediately after completion of 10 sessions treatment and at 4-week follow-up. 
 
5. 
Study Population: 
36 adults with chronic incomplete cervical SCI will be recruited from TIRR/Memorial Hermann, 
local healthcare providers and from support groups in Houston area. 
 
Participants will be included if they have: 
(1) diagnosis of a chronic incomplete cervical lesion as defined by the American Spinal Injury 
Association Impairment scale classification and at least for 6 months post injury; 
(2) upper-extremity weakness associated with tetraplegia with minimal residual thumb and index 
finger movement sufficient to grip small objects such as marble; 
(3) age 18 - 70 years; 
(4) no brain injury; 
(5) no planned alteration in upper-extremity therapy or medication for muscle tone during the 
course of the study; 
(6) no contradiction to tDCS 
(7) access to internet at home. 

IRB NUMBER: HSC-MS-21-0114 
IRB APPROVAL DATE: 03/15/2022 
 
Subjects will be excluded if they have: 
(1) prior history of seizure; 
(2) modifications in chronic use of neuroactive medication (e.g., neurostimulants, 
anticonvulsants, or antidepressants) during study period (between baseline and follow-up); 
(3) any joint contracture or severe spasticity in the affected upper extremity, as measured by a 
Modified Ashworth Score ≥ than 3 out of 4. 
 
6. 
Study Procedures: 
Baseline Assessment (Duration: two to three hours): For both SCI subjects and healthy 
volunteers, 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 (SCI) will be evaluated for upper extremity motor functions. Arm and hand 
functions will be assessed with Graded Redefined Assessment of Strength, Sensibility and 
Prehension (GRASSP), ASIA upper extremity scale (motor and sensory), grasp and release test 
and independence in daily functions will be assessed with SCIM-II. 
Caregiver training: On the day of in-clinic baseline assessment, caregiver/family member who 
will be delivering the therapy at home will be trained on intervention protocol (localization of 
primary motor cortex to deliver the tDCS, operating the tDCS machine, operating the laptop and 
videoconference system, using special exercise equipment). Then they will take the tDCS 
device, exercise equipment and lap top computer home. 
 
Treatment at home (Duration: two hours): Home-treatment sessions will start on the following 
week (Monday through Friday) and continue for two-weeks (total 10 treatment sessions). During 
each treatment session primary motor cortex (C3 or C4 according to international EEG system) 
will be stimulated with anodal tDCS at 2mA for 20 minutes. Electrode sizes are 5x7cm, saline- 
soaked. Active (anodal) electrode) will be placed over the primary motor cortex and reference 
electrode will be placed over contralateral supraorbital area. This single-position headgear 
include clearly labeled sponge markers to eliminate room for user error (see attached brochure 
for tDCS with head gear and sponge electrodes). Participants in the sham stimulation (control) 
group will use same stimulation location, however the duration of stimulation will be set to 30 
seconds at the beginning and end of 20 minutes. This is a reliable method of sham stimulation 
as sensations arising from tDCS treatment occur only at the beginning of application (Gandiga, 
Hummel et al. 2006). Subjects often feel during current ramp up; however the same procedure 
will be adopted for sham stimulation (that will receive active current for 30 seconds only 
(insufficient time to produce meaningful changes) and therefore mimic the initial sensation 
associated with active stimulation. It should be noted that less than 3 minutes of tDCS induces 
no effects on cortical excitability (Nitsche and Paulus 2000) and also using 30 seconds of sham 
is a reliable method of blinding as shown by a randomized controlled study (Gandiga, Hummel 
et al. 2006). 
 
Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and 
finger exercises for 60 minutes. Exercise difficulty will gradually increase and adjusted as 
needed per participants tolerance. All treatment sessions will be supervised in real-time via 
videoconferencing by Dr.Yozbatiran in her office at the NeuroRecovery Research Center at 
TIRR/Memorial Hermann. 
The tDCS device in this study (Soterix 1x1 tdCS mini-CT stimulator, see attachment), is 
specifically designed and developed for home-use. The intensity and duration of stimulation will 
be pre-programmed by Dr.Yozbatiran. After pre-programming device, it won’t allow 
patient/caregiver to make changes. All session will be monitored remotely by Dr.Yozbatiran. 
After home-therapy ends, study participant will bring the FitMi and Music Glove devices, and the 
laptop back to the research lab. 

IRB NUMBER: HSC-MS-21-0114 
IRB APPROVAL DATE: 03/15/2022 
 
 
Schedule of activities 
Event 
Baseline 
(Day -6 to 0) 
Treatment 
Sessions (1-10) 
Post-treatment 
(Day 5±3) 
Follow-up 1 
(Day 35±5) 
Informed Consent 
X 
Inclusion/Exclusion Criteria 
X 
Demographics 
X 
Medical and Social History 
X 
Medication Checklist 
X 
X 
X 
ASIA-Impairment Scale 
X 
X 
X 
GRASSP 
X 
X 
X 
Grip Strength 
NHPT 
X 
X 
X 
SCIM-II 
X 
X 
X 
tDCS 
X 
Music Glove and FitMi arm 
training 
1-10 
tDCS-Side Effects Questionnaire 
1-10 
Pain and Fatigue 
1-10 
Participant-tDCS &Arm Exercise 
Survey 
1,6,10 
Participant- Usefulness of 
Intervention Survey 
X 
X 
Caregiver tDCS&Arm Exercise 
Survey 
1,6,10 
Caregiver-Usefulness of 
Intervention Survey 
X 
X 
 
Post-treatment and Follow-Up Assessment (Duration: two-hours ): During this period subjects 
will be asked to come within a-week after they have completed the study and at week 4 for 
follow-up. GRASSP, Grip Strength, SCIM-II and fNIRS measurements will be repeated at post- 
treatment visit and at 4-week follow-up visit. 
 
7. 
Potential Risks/Discomforts 
tDCS: Transcranial direct current stimulation (tDCS) is a technique that poses a non-significant 
risk to subjects. The safety of this technique has been addressed and tested by multiple 
researchers (e.g., Hummel, et al., (Hummel and Cohen, 2005); Fregni, et. al., (Fregni et al., 
2006a, Iyer et al., 2005); Nitsche, et al., (Nitsche et al., 2003c, Nitsche et al., 2003b, Nitsche et 
al., 2003a), (Nitsche et al., 2004); Priori, et al., (Priori, 2003)). Researchers have concluded that 
tDCS, as applied in a manner similar to our proposed protocol, induces only temporary mood, 
cognitive / motor effects, and no negative side effects. No undesirable or long-lasting effects 
have been reported, nor have any subjects reportedly abandoned a study due to discomfort. 
The most common side effects according to a recent consensus are: headache, dizziness, 
nausea, itchy sensation as well as irritation under the area of the electrodes (Nitsche et al., 
2008). Researchers at the National Institute of Neurological Disorders and Stroke (NINDS), Iyer 
et al., (2005) (Iyer et al., 2005) conducted a safety study on tDCS, investigating 20-minute 
sessions of 1 mA and 2 mA current stimulation with healthy controls (n=103). No negative 
effects were identified. Nitsche and colleagues (2004) found no measurable structural changes 
in brain tissue due to tDCS (Nitsche et al., 2004). Finally, two recent studies showed that 

IRB NUMBER: HSC-MS-21-0114 
IRB APPROVAL DATE: 03/15/2022 
 
several sessions of tDCS are safe to be used in chronic pain syndromes such as fibromyalgia 
and spinal cord injury (Fregni et al., 2006c), (Fregni et al., 2006a). Thus, a growing body of 
research from different laboratories has shown that tDCS is a safe, noninvasive and painless 
technique for modulating neural excitability, with measurable but only transient effects. 
The current protocol uses stimulation level of 2mA and a duration of 20minutes which fells 
within safety limits published by numerous clinical studies applying tDCS with human subjects. 
In our lab at NeuroreRecovery Research Center at TIRR, we completed several tDCS studies 
(HSC-MS-12-0868, HSC-MS-15-0269, HSC-MS-14-0354) and did not observe any serious side 
effects that required termination of subject’s treatment program. As expected, tingling was the 
most common transient symptom followed by skin redness. Both are physiological responses to 
direct current stimulation and require no medical action. 
 
The safety of tDCS in the pediatric and pregnant population has not been assessed. Therefore 
female subjects will be questioned for pregnancy at the screening, and pregnant women will be 
excluded. If a subject becomes pregnant during the course of the study, they will be withdrawn 
from the study. 
 
Arm Exercise- Training: Patients with spinal cord injury sometimes develop pain or discomfort 
in the shoulders and arm. Subjects will be questioned for fatigue or discomfort during training 
sessions, and frequent breaks will be given to mitigate muscle fatigue. If any discomfort related 
to prolonged sitting happens, the training will be paused and participant will be encouraged to 
change his/her sitting position (weight shifting). 
If there is evidence that pain or fatigue is worsened by the therapy, the sessions will be reduced 
or discontinued. All therapy sessions will be supervised and monitored by Dr.Yozbatiran. 
 
Assessment/Questionnaires: All assessments will be performed in a designated room inside 
NeuroRecovery Research Center at TIRR Memorial Hermann. 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. 
 
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. The use of fNIRS is recently approved 
by UThealth IRB for the study #HSC-MS-16-0237 in patients with stroke. 
 
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 

IRB NUMBER: HSC-MS-21-0114 
IRB APPROVAL DATE: 03/15/2022 
 
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. 
 
8. 
Data and Safety Monitoring 
There is no DSMB assigned for this study. 
 
9. 
Data analysis. 
Data for feasibility and adherence will be analyzed using descriptive statistics. For effectiveness, 
difference in GRASSP score in active arm and between active vs sham arm (immediately after 
treatment - baseline) will be analyzed with paired t test (if the normality is satisfactory with 
Kolmogrov-Smirnov test).  If the K-S test suggests skewed distribution, we will conduct 
Wilcoxon signed rank test and Wilcoxon rank sum test for these two analyses. 
In multivariable analysis, we will fit a mixed model for data collected at baseline and ten 
sessions and at 30-days follow-up in both study arms. Patient will be included as random effect 
of the mixed model. The fixed effects include treatment arm (active, sham) and time (0 for 
baseline, 1-10 for ten sessions). First, we will consider time levels as nominal and test 
interaction between treatment and time. The interaction will be added if it will be significant. 
Second, we hope to parametrically model time. The mean trajectory plot will guide us on the 
parametric form of time. Our emphasis will be linear time and 3rd-order polynomial time. We tend 
to favor the 3rd-order polynomial time as we believe that the GRASSP score will increase greatly 
for the first few sessions and then become stable. 
In mixed model analysis, besides incorporating patient random effect, we will also test if there 
exists stronger correlation among measurements with shorter time intervals. We will specify a 
few serial correlation patterns including exponential, Toeplitz and banded Toeplitz. The random 
effect specification will be extended to incorporate random time slope. We will fit all these 
models and report AIC values to guide our decision on covariance pattern. 
 
10. 
Potential Benefits 
The results of these studies may benefit subsequent future subjects if remotely supervised, 
home-based combined tDCS and repetitive arm training proves to be effective when compared 
to repetitive arm training only. 
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. 
 
11. 
Risk-Benefit Ratio: 
The potential improvement of arm and hand movement outweighs the risk of non-invasive brain 
stimulation, fatigue, pain and discomfort. 
 
12. 
Consent Procedures: 
Informed consent will be obtained from the subject at NeuroRecovery Research Center at The 
Institute for Rehabilitation and Research (TIRR)/ Memorial Hermann. After the patient is 
identified as eligible participant, Dr.Yozbatiran or her research team will obtain a written 
informed consent form. 
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. 

IRB NUMBER: HSC-MS-21-0114 
IRB APPROVAL DATE: 03/15/2022 
 
13. 
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. There will be no online data transfer, however, to 
ensure confidentiality and cybersecurity during remote supervision, Dr.Yozbatiran will work with 
UThealth IT department. 
 
14. 
Costs: 
The subject will not be expected to pay any costs. 
 
15. 
Payments: 
Subjects who travel to the study appointments will be reimbursed $20 per screening and 
assessment visit. Subjects who complete all study procedures and assessment visits will be 
reimbursed with additional $20. Total compensation per subject will not exceed $100. 
 
 
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