Impact of Combining tsDCS and Robotic Exoskeleton Gait Training on Spinal Excitability and Gait Function in Individuals With SCI
Phase: NA
Conditions: Spinal Cord Injury
Sponsor: The University of Texas Health Science Center, Houston

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Impact of Combining Transcutaneous Spinal Direct Current Stimulation (tsDCS) and Robotic 
Exoskeleton Gait Training on Spinal Excitability and Gait Function in Individuals with Spinal 
Cord Injury 
 
NCT02862080 
 
Version Date: 06/24/2016 
 
 

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Adapted from NIH protocol template and ICH Guidelines 
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Protocol Title: 
Impact of Combining Transcutaneous Spinal Direct Current Stimulation 
(tsDCS) and Robotic Exoskeleton Gait Training on Spinal Excitability and 
Gait Function in Individuals with Spinal Cord Injury 
Principal Investigator: 
Marcie Kern, PT, MS 
Co-Investigator: 
Shuo-Hsiu Chang, Ph.D. 
Population: 
Human subjects (male and female), age 18 years or older, who have a 
confirmed diagnosis of chronic (>6 months post injury) motor incomplete 
spinal cord injury. 
Number of Sites: 
1. TIRR Memorial Hermann 
Study Duration: 
2 years 
Subject Duration: 
5 weeks 
 
 
 
 
GENERAL INFORMATION 
Spinal cord injuries lead to a host of primary and secondary physical impairments that 
can interfere with an individual’s health and participation in life activities. Even with intensive 
rehabilitation many persons affected by spinal cord injury (SCI) will lead sedentary lifestyles. 
Individuals with SCI face a multitude of challenges due to physical difficulties that impact their 
health, independence, and satisfaction with life. With the integration of modern technology 
into rehabilitation, multiple techniques have been developed that combine our knowledge of 
walking with robotic technology. Further, emerging research indicates that application of 
electrical stimulation directly to the spinal cord can result in active motor recruitment below 
the level of injury for individuals with complete SCI.1-2   Non-invasive electrical stimulation, 
transcutaneous spinal direct current stimulation (tsDCS), has the ability to alter spinal reflexes 
and modulate  spinal cord excitability in healthy subjects and individuals with SCI.3-17 
Therefore, tsDCS has the potential to modulate and induce spinal cord excitability and 
neuroplasticity that leads to recovery after SCI.  The purpose of this study is to determine 
whether tsDCS is safe for individuals with SCI.  In specific Aim 1, we will determine whether 
tsDCS is safe for patients with SCI. In specific aim 2, we will investigate the potential 
neurophysiological changes and functional improvements in gait for individuals with SCI after 
combined application of tsDCS and exoskeleton assisted gait training. We hypothesize that 
when subjects are receiving the tsDCS in combination with exoskeleton training they will 
demonstrate an increased magnitude in spinal reflex which will correlate with improvement in 
gait speed, as compared to when subjects are receiving exoskeleton training without tsDCS. 
 
 
 
BACKGROUND INFORMATION 
As of 2014, there were an estimated 276,000 persons in the United States living with a 
SCI, and an additional 12,500 new cases added each year. Of those injured, approximately 66% 

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presented with incomplete spinal lesions.18 While individuals with motor incomplete lesions 
may regain some ability to ambulate over ground, ambulation in the community and household 
may be limited or impossible secondary to the physical demands encountered during gait. This 
contributes to an extremely limited number of steps taken per day, and often leads to a 
sedentary lifestyle.19 It is well appreciated that a sedentary lifestyle from paralysis contributes 
to many secondary medical problems such as diabetes, obesity, osteoporosis/osteopenia, 
urinary, pulmonary and cardiovascular disease.20-23 Walking, therefore, is not only an important 
activity of daily living but also helps to reduce secondary complications. Most importantly, 
recovery of walking ability is one of the single most predictors of quality of life after spinal cord 
injury.24, 25 
Historically therapy was limited to teaching compensatory strategies, as little was known 
about neuroplasticity of the spinal cord. Evidence is now growing to support the ability of the 
spinal cord to adapt after injury.26  Emerging research indicates that intentional massed practice 
of activity-based training may promote neural plasticity and cortical reorganization and 
subsequent recovery of walking ability after neurological injury, including SCI.27-32 Moreover, 
studies have shown that placing the body in a load bearing position and moving the lower limbs 
in a repetitive stepping pattern leads to improved locomotor recovery.33-35   One example, 
locomotor training, using body weight supported treadmill training (BWSTT), drives changes in 
spinal cord pathways by increasing the excitability of the spinal cord leading to recovery of 
movements controlled below the level of injury.36, 37   In BWSTT, a body weight support system 
allows for unweighting of the body while using a treadmill to provide repetitive stepping. An 
alternative method for achieving load bearing, repetitive stepping in an overground 
environment with less cost and energy to clinicians is use of lower extremity robotic 
exoskeletons for gait training. 
In spite of the fact that the spinal cord has shown great potential for neuroplasticity, no 
one intervention has proven successful at inducing changes in the cord and return of full pre- 
injury function prior to SCI.  It is important to make available in the clinic interventions that 
combine neuroplasticity principles and focus on restoring function after neurological injury. 
Electrical stimulation is currently readily available and utilized in the clinic for spasticity, pain, 
muscle strengthening and neurological recovery. Electrical stimulation can be applied at the 
muscle, nerve or spinal level. Exciting new research is demonstrating that application of 
electrical stimulation directly to the spinal cord can result in active motor recruitment below 
the level of injury for individuals with complete SCI.1-2 However, this technology is only available 
in research phase and requires invasive surgery. 
An alternative non-invasive method for stimulating the spinal cord is through the use of 
transcutaneous spinal direct current stimulation (tsDCS).  tsDCS applies electrical current to the 
spinal cord via surface electrodes placed on the skin. It has been demonstrated in animal 
models and healthy human subjects that tsDCS has the ability to alter spinal reflexes and has an 
effect on spinal cord excitability.3-16 The use of tsDCS has been evaluated in healthy individuals, 
however there is only one research study to date that investigates the use of tsDCS on 
individuals with SCI.17 Hubli found that individuals with complete SCI demonstrated changes in 
spinal reflexes after application of tsDCS.17  This means tsDCS has the potential to alter spinal 
cord excitability below the level of lesion. 

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Although this technology has been around for decades and tsDCS has been shown to 
modulate the excitability of the spinal cord, limited research has investigated its use in the SCI 
population. Before this technology could promote recovery after SCI, further research is needed 
to evaluate the safety and efficacy of this intervention. Therefore, the purpose of this pilot 
study is to determine whether tsDCS is safe for individuals with SCI.  It is hypothesized that use 
of tsDCS will lead to measurable changes in spinal excitability (measured by H-reflex in soleus 
muscles) in individuals with SCI. We further hypothesize that this potential neurophysiological 
change could lead to gait improvements. To answer our questions, we will use exoskeleton 
assisted gait training as a standard gait training intervention in combination with tsDCS. 
 
OBJECTIVES 
The purpose of this study is to determine whether tsDCS is safe for individuals with SCI. 
Specific Aim 1: To determine whether tsDCS is safe for patients with SCI.  There is one 
study that has utilized tsDCS in 17 individuals SCI17.  No adverse events were noted in this study, 
therefore we hypothesize that all subjects will tolerate the use of tsDCS without adverse 
reactions. 
Specific Aim 2: To investigate the potential neurophysiological changes and functional 
improvements in gait for individuals with SCI after combined application of tsDCS and 
exoskeleton assisted gait training. It has been demonstrated that use of tsDCS has an impact on 
spinal excitability, however there has been no investigation on the potential impact changes in 
spinal excitability may have on functional mobility. We hypothesize that when subjects are 
receiving the tsDCS in combination with exoskeleton training they will demonstrate an 
increased magnitude in spinal reflex which will correlate with improvement in gait speed, as 
compared to when subjects are receiving exoskeleton training without tsDCS. 
 
STUDY DESIGN 
 
A single case series design (baseline, intervention, and combined intervention) is used in this 
pilot study. The study schematic diagram is presented in Figure 1. 
 
STUDY POPULATION 
We plan to enroll 4 human subjects (male and/or female), age 18 years or older, with a 
confirmed diagnosis of chronic motor incomplete SCI, classified by the American Spinal Injury 
Association Impairment Scale (AIS) grades C or D. 
Potential subjects will be recruited from TIRR Memorial Hermann outpatient clinics and 
therapy services. Subjects will be excluded if they lack sufficient range of motion at lower 
extremity preventing achievement of normal stepping kinematics, are unable to physically fit 
within the exoskeleton, have evidence of an unstable spine, presence of lower extremity or 
pelvic fractures or other conditions limiting weight bearing into legs, history of severe 
neurological disorder other than SCI, known peripheral neuropathy or any pathology that could 
influence reflex excitability, difficulty completing forms written in English or following verbal 
instructions provided in English, use of mechanical ventilation for respiratory support. Final 
exclusion criteria include conditions in which use of electrical stimulation is contraindicated: 
presence of cardiac pacemaker, deep brain stimulator, or evidence of cancerous (malignant) 

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tissue, and presence of metal in thoracic spine and region of electrode placement.  See chart 
for all inclusion and exclusion criteria. 
 
 
Inclusion Criteria 
Exclusion Criteria 
 Male or non-pregnant female 
 ≥18 years of age 
 Able to achieve adequate fit within 
exoskeleton 
 Diagnosis of spinal cord injury, T10 
level and above (T11 and 12 may 
participate if no clinical signs of lower 
motor neuron lesion present) 
 Minimum of 6 months post injury 
 Sufficient range of motion to attain 
normal, reciprocal gait pattern, and 
transition from normal sit to stand or 
stand to sit 
 Weight <220 pounds 
 Intact skin on all surfaces in contact 
with device and load bearing surfaces 
 Ability to perform informed consent 
 Pregnancy 
 Spinal instability 
 Unhealed limb or pelvic fractures or any 
condition restricting weight bearing in limbs 
 Presence of peripheral neuropathy or any 
pathology that could influence reflex 
excitability 
 Diagnosis of other neurological injury other 
than SCI such as CVA, MS, ABI, CP 
 Uncontrolled spasticity (≥3 on Modified 
Ashworth Scale) 
 Colostomy 
 Decreased range of motion or contractures 
in legs (>10° at hips, knees or ankles) 
 Uncontrolled autonomic dysreflexia 
 Unresolved deep vein thrombosis 
 Inability to tolerate standing due to 
cardiovascular issues or orthostatic 
hypotension 
 Severe comorbidities: active infections, 
heart, lung, or circulatory conditions 
 Pressure sores, impaired skin integrity 
 Use of mechanical ventilation for respiratory 
support 
 Presence of any of the following 
contraindications to electrical stimulation: 
cardiac pacemaker, deep brain stimulator, 
or evidence of cancerous (malignant) tissue 
 Presence of metal in thoracic spine or region 
of electrode placement 
 
Procedures 
The proposed investigation is a single case series design (baseline, intervention, 
combined intervention). The study schematic diagram is presented in Figure 1. 
Subjects will be asked to attend a screening visit, 2 baseline visits and 15 training 
sessions.  The screening visit will take 30 – 45 minutes and assessment of range of motion, 
flexibility, spasticity, mobility, and measurements will be performed to ensure individual will fit 
inside the robotic exoskeleton. Baseline visits will be scheduled for 1 hour and will include 
spinal reflex testing using the Soleus Hoffman Reflex (H-Reflex) and a 10 Meter Walk Test 

UT Houston Protocol Template 
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IRB NUMBPEaRge: H6SoCf-1M2S-16-0329 
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(10MWT).  Subjects will participate in two types of training visits; exoskeleton training and 
exoskeleton training plus tsDCS.  Training visits will be scheduled for 0.5-1.5 hours depending 
on the intervention condition (exoskeleton training or exoskeleton training and tsDCS 
intervention). There will be a 1 week wash out period between intervention conditions. See 
Table 1 and 2 for timeline. 
 
Table 1: Timeline for subjects 1 and 3: A-BC-C-BC design 
Sub 1 (cathode) and Sub 3 (anode) 
A-BC-C-BC 
A = Baseline, B = tsDCS, C = Ekso 
5 weeks, 17 visits, 17.5 hours 
Visit 
1/A 
2/A 
3/ 
BC 
4/ 
BC 
5/ 
BC 
6/ 
BC 
7/ 
BC 
Wash out 
8/C 
9/C 
10/C 
11/C 
12/C 
Wash out 
13/ 
BC 
14/ 
BC 
15/ 
BC 
16/ 
BC 
17/ 
BC 
Day 
1 
5 
8 
9 
10 
11 
12 
22 
23 
24 
25 
26 
36 
37 
38 
39 
40 
Time 
1 
hr 
1 
hr 
1.5 
hr 
1 
hr 
1 
hr 
1 
hr 
1.5 
hr 
1 
hr 
.5 
hr 
.5 hr 
.5 hr 
1 hr 
1.5 
hr 
1 
hr 
1 
hr 
1 
hr 
1.5 
hr 
H- 
Reflex 
X 
X 
X 
X 
X 
X 
X 
X 
10MWT 
X 
X 
X 
X 
X 
X 
X 
X 
Ekso 
X 
X 
X 
X 
X 
Ekso + 
tsDCS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Table 2: Timeline for Subjects 2 and 4: A-C-BC-C design 
Sub 2 (cathode) and Sub 4 (anode) 
A-C-BC-C 
A = Baseline, B = tsDCS, C = Ekso 
5 weeks, 17 visits, 15 hours 
Visit 
1/A 
2/A 
3/ 
C 
4/ 
C 
5/ 
C 
6/ 
C 
7/ 
C 
Wash out 
8/ 
BC 
9/ 
BC 
10/ 
BC 
11/ 
BC 
12/ 
BC 
Wash out 
13/ 
C 
14/ 
C 
15/ 
C 
16/ 
C 
17/ 
C 
Day 
1 
5 
8 
9 
10 
11 
12 
22 
23 
24 
25 
26 
36 
37 
38 
39 
40 
Time 
1 
hr 
1 
hr 
1 
hr 
.5 
hr 
.5 
hr 
.5 
hr 
1 
hr 
1.5 
hr 
1 
hr 
1 
hr 
1 
hr 
1.5 
hr 
1 
hr 
.5 
hr 
.5 
hr 
.5 
hr 
1 
hr 
H- 
Reflex 
X 
X 
X 
X 
X 
X 
X 
X 
10MWT 
X 
X 
X 
X 
X 
X 
X 
X 
Ekso 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Ekso + 
tsDCS 
X 
X 
X 
X 
X 
 
Screening 
After informed consent is provided, the subject will undergo a screening evaluation to 
assess skin integrity, hip, knee, and ankle range of motion, and spasticity. We will also perform 
assessments of functional mobility and measurements to ensure the individual will safely fit 
inside the robotic exoskeletons. 
 
Baseline Visits 
Subjects will participate in two baseline visits, 4 days apart. The visit will last 1 hour and 
will include assessment of soleus H-Reflex and 10 meter walk test on arrival and 40 minutes 
after initial assessment. Subjects will be asked to minimize their activity between assessments 
by either sitting in a chair or lying on a mat. 
 
Training Visits 
Each training visit will involve either an exoskeleton intervention or a combined 
exoskeleton and tsDCS intervention. Subjects will participate in a total of 15 training visits. 

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Exoskeleton Intervention: Each exoskeleton intervention will last 20 minutes. During 
the exoskeleton training session, subjects will wear Ekso®, a lower extremity exoskeleton 
robotic walking device. Initial training will focus on static and dynamic standing balance and 
weight shift training with the exoskeleton and progress to more difficult activities such as 
transitioning form sit-to-stand and stand-to-sit, walking, and turning. There will always be at 
least one trainer present during the training sessions to provide varying levels of assistance. As 
a subject's skill with the powered exoskeleton improves, the need for trainer assistance will be 
proportionately reduced. At the conclusion of 20 minutes of exoskeleton gait training, the 
subject will perform a 10 Meter Walk Test. 
Safety: There will always be at least one trainer present during the training sessions to 
provide varying levels of assistance. A 2nd staff will stand and walk with the subject if needed to 
ensure safety and prevent falls. Subjects will wear a safety harness attached to an overhead 
body weight support system to prevent falls if necessary. 
 
tsDCS Intervention: tsDCS interventions will last 20 minutes.  Subjects will be assigned 
to receive anode or cathode stimulation.  Direct current stimulation will be delivered using 
Soterix Medical 2x1s Transcutaneous Spinal Direct Current Stimulator.  Stimulation will be 
provided following published tsDCS protocol7, 17. One electrode (50 cm2) will be placed along 
center of spine centered over the spinous processes of T10. The reference electrode will be 
placed over the R shoulder. Direct current intensity will be applied at 2.5 mA (0.05 mA/cm2) 
with a total charge of 60 mC/cm2 for 20 minutes. These stimulation parameters are below the 
known threshold for possible tissue damage38. 
Subjects will participate in individualized training sessions at UT Health Motor Recovery 
Laboratory at the NeuroRecovery Research Center at TIRR Memorial Hermann. 
 
Figure 1: Study Schematic Diagram 

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Outcome Measures 
Subjects will participate in a screening, 2 baseline visits and 15 intervention visits. 
Outcome measures that will occur at baseline and during intervention visits and will include 
spinal reflex testing using the Hoffman Reflex (H-Reflex) and 10 Meter Walk Test (10MWT). 
Assessments: 
 Soleus H-reflexes: H-reflex will be elicited by placing the cathode of an electrical 
stimulator in the popliteal fossa and stimulating N. tibialis. Surface electromyography 
electrodes will be placed at the soleus muscle of the testing leg to record the electrical- 
induced muscle activity. At the beginning of the test, stimulus thresholds and maximal 
amplitudes of H-responses (Hmax) and M-responses (Mmax) will be assessed. The 
stimulus intensity applied to elicit H-reflexes will be chosen just below stimulus intensity 
required to elicit Hmax, i.e. 0.9 times. The size of each H-reflex will be measured as the 
peak-to-peak amplitude of the non-rectified EMG trace (Figure 2). H-reflex magnitude 
will be normalized by expressing it as a percentage of the amplitude of Mmax. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2. An illustration of H-reflex and proceeding 
M-wave elicited from a patient with SCI 
 
 
 10 Meter Walk Test (10MWT): The 10MWT will assess subject’s gait speed.  Four marks 
will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 
meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and 
recorded as their gait speed. Subjects will perform a 10MWT without use of 
exoskeleton. 
  Exoskeleton user feedback: A questionnaire will be administered to allow participants 
to provide feedback regarding their experience after completion of treatment sessions. 
 
Treatment sessions: We will track any signs of adverse reaction to the tsDCS intervention such 
as skin irritation, complaints of pain or discomfort continuously throughout subject’s 
participation. 
 
Tentative Timeline The proposed timeline to complete the study is 2 years. 
 
PHOTOGRAPHY and VIDEOTAPING 
We would like to obtain photographs and video during the tsDCS and exoskeleton 
treatment sessions. The goal of the photography and videotaping will be used for educational 

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purposes when presenting results of this study. The photographs will be used to demonstrate 
application of tsDCS and what exoskeleton training looks like. The identity of subjects will not 
be revealed in the photograph. If a photograph or video is used, a black box will be placed in 
front of subject’s face to protect their identity. Any photographs and videos taken during the 
study will be saved on a locked computer in a file labeled with the subject’s research number 
and no other identifying information. These files will be saved for five years after which they 
will be deleted. 
 
DATA and SAFETY MONITORING 
We will use following strategies to prevent some expected events for this study: 
1)   Loss of confidentiality or privacy 
Information obtained for this study will be kept private to the extent allowed by law. However, 
research information may be shared with the University of Texas Health Science Center at 
Houston Institutional Review Board (IRB), the research physician investigator, the research staff 
and others who are responsible for ensuring compliance with laws and regulations related to 
research. 
The study will be performed at UT Health Motor Recovery Laboratory at the TIRR 
NeuroRecovery Research Center. 
Data will be collected on paper forms which will be kept in a locked room in a locked filing 
cabinet in the research office. To allow for data analysis, data will be de-identified and entered 
into an excel spreadsheet. All computers are password protected and therefore, only 
authorized persons have the access to the electronic files saved in computers and will adhere to 
TIRR Memorial Hermann standards. 
2)   Loss of saved electronic data after a computer crash 
All original data will be maintained on paper data collection forms. De-identified data may be 
entered into computer for data analysis.  A standard procedure of electronic file backup is 
established and enforced by the PI. All file backups are routinely performed in the local hard 
drive. 
However, if there are other unanticipated problems which occur during and after data 
collection: the original paper version of the data will be maintained in the locked file cabinet. 
3)   Loss of balance or fall from testing 
One research team member will remain next to the subject as long as the subject is donned in 
the exoskeleton robot to prevent loss of balance or fall whether sitting or standing. If a fall or 
significant loss of balance occurs, one staff physician will be notified immediately. All adverse 
events will be reported per CPHS protocol. 
4)   Possible skin irritation 
Local skin irritation, bruising, swelling, or temporary discomfort following wearing of the 
exoskeleton and/or post tsDCS intervention may occur. Prior to tsDCS application and donning 
the exoskeleton subject’s skin will be inspected by a licensed Physical Therapist for baseline, 
and compared after tsDCS intervention and doffing exoskeleton. Any differences will be 
recorded and followed up with the study physician accordingly.  All adverse events will be 
reported per CPHS protocol. 
5)   Bone Fracture 

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The risk of fracture to the subject is no greater with the use of exoskeleton than conventional 
weight bearing and walking therapy. 
 
 
 
STATISTICS 
Descriptive statistical analysis will be performed to examine the trend of the outcome 
measures at baseline, intervention and combined intervention for each case study series. 
 
ETHICS 
 
 
The study will be performed under the prevue and in accordance with the rules set by 
the Committee for the Protection of Human Subjects (UT IRB). Potential subjects will be 
identified by physiatrists working in the outpatient clinic and/or on the inpatient wards at The 
Institute for Rehabilitation and Research (TIRR) Memorial Hermann. Once identified, the 
potential subjects will be approached and asked if they wish to discuss a study utilizing 
electrical stimulation and exoskeletons (Robotic suits worn on the outside of the body) for 
individuals with spinal cord injury. It will also be explained that choosing not to inquire further 
about the study will in no way jeopardize the relationship with anyone at TIRR or in the 
Memorial Hermann system. Once the potential subject agrees he/she will be introduced to 
either the Principal Investigator or the Co-Investigator. Once the potential subject agrees to 
discuss the study, the individual and anyone that the potential subject wishes to accompany 
him/her will go into a private room to discuss the contents of the consent form with either the 
Principal Investigator or the Co-Investigator. After the consent is reviewed in its entirety, and 
after allowing ample time for questions, either the Principal Investigator or the Co-Investigator 
will give the potential subject time to discuss the study with whomever the potential subject 
cares to discuss the study with. If the subject agrees to enroll in the study, the Principal 
Investigator or Co-Investigator will review the informed consent form with the subject in its 
entirety. 
 
DATA HANDLING and RECORD KEEPING 
The subject’s name and demographic information will be collected prior to testing. Each 
subject will be assigned an identification number which will be used from this point forward. All 
measurements will be stored according to the identification number. All research materials will 
be kept in a locked file cabinet in the research office. All computers are password protected 
and only authorized persons have the access to the electronic files saved in computers. Paper 
data will be stored in the UT Health Motor Recovery Laboratory research office in a locked file 
cabinet. Access to the file cabinet will be given to the Primary Investigator and authorized team 
members. All electronic data stored on the hard drive of the desktop machine will be password 
protected and available only to the authorized research team members. Identifiable data will 
be stored for 5 years after the study is completed. Stored files will be deleted from the portable 
hard drive after 5 years as well. Identifiable data will be shredded at the end of 5 years after the 
completion of the study. 

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QUALITY CONTROL and ASSURANCE 
To ensure research integrity, standard written procedures for all tests will be 
established by the Principle Investigator and the Study Coordinator who will then assess each 
team member’s competence for research conduction on a regular basis. Therefore, the testing 
protocol will be consistent throughout the entire data collection for this study. 
 
COSTS, REIMBURSEMENTS and COMPENSATION 
Subjects will receive $150 stipend for participation in this study upon completion of 15th 
treatment visit.  Subject’s parking fees for each visit will also be covered. Therefore, subjects 
will incur no costs for participating in the study. 
 
FUTURE STUDIES 
Subject will be asked to answer a question regarding their interest in being contacted in 
the future to participate in other studies. Subjects will be given the choice to say yes or no if 
they agree to be contacted in the future regarding other projects. 
 
PUBLICATION PLAN 
The results of this study will be used for presentation at national conferences and 
publications in peer-reviewed journals. The publications will be provided without cost to the 
study participants. 
 
LITERATURE CITED 
1.   Rejc E, Angeli C, Harkema S.  Effects of Lumbosacral Spinal Cord Epidural Stimulation for 
Standing after Chronic Complete Paralysis in Humans. PLoS One. 2015; 10(7): e0133998. 
2.   Angeli CA, Edgerton VR, Gerasimenko YP, Harkema SJ.Altering spinal cord excitability 
enables voluntary movements after chronic complete paralysis in humans. Brain. 
2014;137(Pt 5):1394-409. 
3.   Ahmed Z. Trans-spinal direct current stimulation modulates motor cortex-induced 
muscle contraction in mice. J Appl Physiol. 2011;110(5):1414–1424. 
4.   Ahmed Z. Effects of cathodal trans-spinal direct current stimulation on mouse spinal 
network and complex multijoint movements. J Neurosci. 2013;33(37):14949–14957. 
5.   Elbasiouny SM, Mushahwar VK. Suppressing the excitability of spinal motoneurons by 
extracellularly applied electrical fields: insights from computer simulations. J Appl 
Physiol. 2007;103(5):1824–1836. 
6.   Radman T, Su Y, An JH, Parra LC, Bikson M. Spike timing amplifies the effect of electric 
fields on neurons: implications for endogenous field effects. J Neurosci. 
2007;27(11):3030–3036. 
7.   Cogiamanian F, Vergari M, Pulecchi F, Marceglia S, Priori A. Effect of spinal 
transcutaneous direct current stimulation on somatosensory evoked potentials in 
humans. Clin Neurophysiol. 2008;119(11):2636–2640. 
8.   Kuo JJ, Lee RH, Johnson MD, Heckman HM, Heckman CJ. Active dendritic integration of 
inhibitory synaptic inputs in vivo. J Neurophysiol. 2003;90(6):3617–3624. 

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9.   Eccles JC, Kostyuk PG, Schmidt RF. The effect of electric polarization of the spinal cord 
on central afferent fibres and on their excitatory synaptic action. J Physiol. 
1962;162:138–150. 
10. Elbasiouny SM, Moroz D, Bakr MM, Mushahwar VK. Management of spasticity after 
spinal cord injury: current techniques and future directions. Neurorehabil Neural Repair. 
2010;24(1):23–33. 
11. Winkler T, Hering P, Straube A. Spinal DC stimulation in humans modulates post- 
activation depression of the H-reflex depending on current polarity. Clin Neurophysiol. 
2010;121(6):957–961. 
12. Cogiamanian F, Ardolino G, Vergari M, et al. Transcutaneous spinal direct current 
stimulation. Front Psychiatry. 2012;3:63. 
13. Lamy JC, Ho C, Badel A, Arrigo RT, Boakye M. Modulation of soleus H reflex by spinal DC 
stimulation in humans. J Neurophysiol. 2012;108(3):906–914. 
14. Lamy JC, Boakye M. Seeking significance for transcutaneous spinal DC stimulation. Clin 
Neurophysiol. 2013;124(6):1049–1050. 
15. Yamaguchi T, Fujimoto S, Otaka Y, Tanaka S. Effects of transcutaneous spinal DC 
stimulation on plasticity of the spinal circuits and corticospinal tracts in humans. Paper 
presented at the 6th International IEEE/EMBS Conference on Neural Engineering. 
November 6–8, 2013, San Diego, CA, USA. 
16. Truini A, Vergari M, Biasiotta A, et al. Transcutaneous spinal direct current stimulation 
inhibits nociceptive spinal pathway conduction and increases pain tolerance in humans. 
Eur J Pain. 2011;15(10):1023–1027. 
17. Hubli M, Dietz V, Schrafl-Altermatt M, Bolliger M. Modulation of spinal neuronal 
excitability by spinal direct currents and locomotion after spinal cord injury. Clin 
Neurophysiol. 2013;124(6):1187–1195. 
18. Spinal Cord Injury Facts and Figures at a Glance. National SCI Statistical Center web site. 
https://www.nscisc.uab.edu/Public/Facts%202015%20Aug.pdf Accessed Sep 2015 
19. Saraf P, et al. Daily stepping in individuals with motor incomplete spinal cord injury. 
Phys Ther. 2010;90(2):224-35 
20. Bauman WA, Spungen AM. Coronary heart disease in individuals with spinal cord injury: 
assessment of risk factors. Spinal Cord. 2008;46:466-76 
21. Gater, DR Jr. Obesity After Spinal Cord Injury.   Phys Med Rehabil Clin N Am. 
2007;18(2):333-51. 
22. Clasey JL, Janowiak AL, Gater DR.  Relationship between regional bone density 
measurements and the time since injury in adults with spinal cord injuries.  Arch Phys 
Med Rehabil. 2004;85(1):59-64. 
23. Charlifue S, Jha A, Lammertse D. Aging with spinal cord injury.  Phys Med Rehabil Clin N 
Am. 2010;21(2):383-402 
24. Anderson KD. (2004). Targeting recovery: priorities of the spinal cord-injured 
population. J Neurotrauma. 21:1371-1383. 
25. Putzke JD, Richards JS, Hicken BL, DeVivo MJ. Predictors of life satisfaction: a spinal cord 
injury cohort study.  Arch Phys Med Rehabil. 2002;83(4):555-61 
26. Rossignol S, Schwab M, Schwartz M, Fehlings MG. Spinal cord injury: time to move? J 
Neurosci. 2007;27(44):11782–11792. 

UT Houston Protocol Template 
Adapted from NIH protocol template and ICH Guidelines 
IRB NUMPBaEgRe :1H2SoCf-1M2S-16-0329 
IRB APPROVAL DATE: 06/24/2016 
 
27. Hoffman LR, Field Fote EC. Cortical reorganization following bimanual training and 
somatosensory stimulation in cervical spinal cord Injury: a case report. Phys Ther. 
2007;87(2):208-23. 
28. Green JB, Sora E, Bialy Y, Ricamato A, Thatcher RW.  Cortical motor reorganization after 
paraplegia: an EEG study. Neurology. 1999;53(4):736–43. 
29. Kambi N, Tandon S, Mohammed H, Lazar L, Jain N. Reorganization of the primary motor 
cortex of adult macaque monkeys after sensory loss resulting from partial spinal cord 
injuries. J Neurosci. 2011;31(10):3696-707. 
30. Girgis J, Merrett D, Kirkland S, Metz GA, Verge V, Fouad K. Reaching training in rats with 
spinal cord injury promotes plasticity and task specific recovery. Brain. 
2007;130(11):2993-3003. 
31. Behrman AL, Bowden MG, Nair PM. Neuroplasticity after spinal cord injury and training: 
an emerging paradigm shift in rehabilitation and walking recovery. Phys Ther. 
2006;86(10):1406-1424. 
32. Hornby TG, et al. Importance of specificity, amount, and intensity of locomotor training 
to improve ambulatory function in patients poststroke. Top Stroke Rehabil. 
2011;18(4):293-307. 
33. Dietz V, Harkema SJ. Locomotor activity in spinal cord-injured persons. J Appl Physiol 
2004;96:1954 –1960. 
34. Wirz M, Zemon DH, Rupp R, Scheel A, Colombo G, Dietz V, Hornby TG.  Effectiveness of 
automated locomotor training in patients with chronic incomplete spinal cord injury: a 
multicenter trial. Arch Phys Med Rehabil. 2005; 86:672– 680. 
35. Dobkin B, Barbeau H. The evolution of walking-related outcomes over the first 12 weeks 
of rehabilitation for incomplete traumatic spinal cord injury: the multicenter 
randomized spinal cord injury locomotor trial. Neurorehabil Neural Repair. 2007; 21:25– 
35. 
36. Barriere G, Leblond H, Provencher J, Rossignol S. Prominent role of the spinal central 
pattern generator in the recovery of locomotion after partial spinal cord injuries. J 
Neurosci. 2008;28(15):3976–3987. 
37. Pinter MM, Dimitrijevic MR. Gait after spinal cord injury and the central pattern 
generator for locomotion. Spinal Cord. 1999;37(8):531–537. 
38. Nitsche M, Liebetanz D, Land N, Antal A, Tergau F, Paulus W. Safety criteria for 
transcranial direct current stimulation in humans. Clin Neurophysiol 2003; 
114(11):2220-2.