Spinal Epidural Electrode Array to Facilitate Standing and Stepping After Spinal Cord Injury
Phase: NA
Conditions: Spinal Cord Injury
Sponsor: University of Louisville

Study Title: Spinal Epidural Electrode Array to Facilitate Standing and Stepping 
after Spinal Cord Injury 
 
 
NCT Number: NCT02339233 
 
 
Document Date: August 8, 2017 

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Final protocol 
 
A. Background, including a brief literature review: 
Spinal cord epidural stimulation (SCES) has been applied alone in a number of 
individuals with clinically complete spinal cord injury (SCI), showing that some alternating 
stepping-like actions can be induced [1]. SCES has been used in combination with 
repetitive stepping on a treadmill for facilitation of walking-like movements after an 
incomplete lesion in two individuals showing stepping could be sustained for a longer 
period of time with less effort in the presence of SCES [2].  This report provides promising 
results of a combination of locomotor training and SCES.  In contrast to our presently 
proposed studies on clinically complete SCI research participants, the previously reported 
studies included patients with incomplete injuries who already had some stepping ability 
before treatment [3]. Several recent findings suggest that a combination of SCES and 
locomotor training in individuals with clinically complete SCI could be very successful for 
the recovery of standing and walking. Locomotor-like patterns can be facilitated by SCES 
in complete spinally transected rats [4], cats [5], and humans with clinically complete SCI 
[6]. However, the long-term functional changes that occur in the spinal cord after clinically 
complete SCI have not been comprehensively examined, and it is likely to require more 
complex and adaptive stimulation protocols in order to achieve optimal results. A key to 
successful broad application of SCES to the majority of individuals with chronic SCI and 
other neurological disorders including multiple sclerosis, brain injury, stroke, and 
Parkinson’s disease may be a functionally-adaptive site-specific stimulation.  However, 
this capability will require a more advanced multi-electrode array technique which we are 
currently developing in preparation for the second phase of our long-term plans. The 
current proposal is a pilot study including 10 research participants with clinically complete 
SCI who will undergo epidural electrode implantation for spinal cord stimulation and 
locomotor training to improve standing and stepping with the combination of epidural 
stimulation and locomotor training; and to provide critical information for the development 
of more advanced electrodes.   
There is substantial evidence that the mammalian spinal cord utilizes autonomous 
oscillating interneuronal circuits (central pattern generators, CPG) that respond to afferent 
input to generate locomotion [7-16].  The importance of afferent input in modulating and 
maintaining these neural locomotor patterns has been abundantly documented, and a 
completely spinal cord transected animal can relearn to hindlimb step and stand with task 
specific training that uses the critical sensory cues needed for each task [17-25].  Further, 
a myriad of reflexes are modulated in amplitude and even reversed by afferent input 
during different phases of the stepping cycle and CPG networks modulate these reflex 
pathways during locomotion [16, 26-42]. The human spinal networks use the sensory 
input during stepping to generate functionally relevant efferent output and, after minutes 
of manual assistance, can generate a series of independent steps. Also, brief standing 
with full weight bearing can be executed after weeks of stand training, again without SCES 
[43].  However, the independence of standing and stepping is not sustainable to allow a 
transition to walking overground [44].  

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We propose that daily locomotor training in the presence of SCES will enable the 
individual with clinically complete SCI to stand and step independently while bearing full 
weight.  Non-patterned electrical stimulation of the lumbar spinal cord can induce 
patterned, locomotor-like activity in individuals with clinically complete SCI [1].  Modifying 
the frequency of stimulation can induce extensor patterns similar to that observed during 
standing [45].  In addition,  when afferent information is also provided there is further 
modulation of these motor patterns elicited by epidural stimulation [46].   Individuals with 
a clinically complete spinal cord injury can execute independent steps using a body 
weight support system on a treadmill (BWST) using manual assistance without epidural 
stimulation.  When combined with SCES, we anticipate the training will be even more 
successful, enabling prolonged periods of independent stepping and standing.   Although 
there will not be a separate control group studied simultaneously, historical controls will 
consist of the best stepping and standing performance that have been observed 
previously in our laboratory in individuals that have a clinically complete SCI. Performance 
beyond this threshold by any individual treated with both epidural stimulation and training 
will be interpreted as a significantly better intervention than training alone.  
Future studies will eventually focus on development and implementation of the more 
advanced multi-electrode array technique that will provide functionally-adaptive site-
specific stimulation.  The adaptive stimulation strategy proposed here takes advantage of 
capabilities of our new array design that are not possible using either conventional or 
commercially available electrode arrays. Our future arrays will provide two key benefits: 
• Our electrode arrays cover a larger area than commercially available arrays, extending 
from the midthoracic to the sacral extents of the spinal cord. It is possible that the optimal 
stimulation sites for facilitating stepping versus standing may be spatially distinct on the 
spinal cord. If this is the case, conventional arrays are less likely to be able to recover 
both stepping and standing in the same patient.  
• Numerous findings suggest that locomotor training may progressively change the state 
of the spinal networks that are responsible for stepping and standing.  Therefore, the 
optimal sites for stimulating these motor tasks may migrate over the course of treatment. 
The adaptive algorithm that we propose will track the optimal sites for stimulation weekly 
and, using this information, we will select electrode(s) from our array that generates the 
most successful standing or stepping. An electrode array will allow us to precisely target 
the most effective stimulation sites. 
A couple of recent studies have shown the ability to produce stepping following complete 
transactions in adult rats when stimulating at the S1 level [65, 66]. Therefore we propose 
the implantation of 2 stimulating electrodes to cover a broader area of the human spinal 
cord.  
 
B. Objectives of the research 
The overall aim is to assess whether task specific locomotor training and SCES can 
induce neural reorganization of the functionally isolated human spinal cord to improve 
standing and stepping in individuals with functionally complete SCI.  We propose that 
locomotor training will result in generation of more effective standing and stepping efferent 
patterns by restoring phase dependent modulation of reflexes and reciprocal inhibition, 

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reducing clonus and mediating interlimb coordination.  We propose that the SCES will 
optimize the physiological state of the spinal cord interneuronal circuitry compromised by 
compensating for loss of supraspinal input for the retraining of these tasks.   
The proposed studies will allow us to gather critical information using commercially 
available electrodes to design the more advanced multi-electrode array technique that 
will be adaptive and conceivably be effective in a wider range of patient populations. The 
current electrodes used in this study will serve two objectives: 1) to improve standing and 
stepping with the combination of epidural stimulation and locomotor training in individuals 
with functionally complete SCI; and 2) to provide critical information for the development 
of more advanced electrodes.   
 
C. Significance of the research 
Locomotor training has been shown to improve overground walking in incomplete SCI 
research participants, however none have fully recovered [47-61].  Identifying the critical 
sensory cues that facilitate more effective motor output can provide knowledge that can 
further improve this rehabilitative approach for walking.  Understanding the mechanisms 
of task specific training in relation to the potential for functional reorganization of the 
human spinal cord after injury can also have significant implications for rehabilitation 
strategies for the recovery of walking [62, 63].  Further, optimizing training strategies for 
functional recovery of spinal circuits after SCI will also be extremely important in 
combination with promising neural regeneration approaches that are continually 
emerging.  
 
D. Thorough description of how human research participants will participate in the 
research 
SCREENING: Evaluation Tests and Pre-Training (1st consent) 
Dr. Maxwell Boakye, Dr. Camilo Castillo, and Susan Harkema, Ph.D., the principal 
investigators of this project, will perform the initial screening of the research participants. 
Dr. Joseph Neimat may perform the surgical implantation procedure. All eligible SCI 
research participants will be invited to the Human Locomotion Research Center to discuss 
the complete protocol and its risks and benefits with Dr. Harkema. The individual will view 
a video or a demonstration that exemplifies the stand and step training and the recording 
apparatus that will be used during testing.  Dr. Harkema will verbally review all other 
testing that will occur and explain that the research participant can refuse any of the tests 
and discontinue their participation at any time without penalty.  Dr. Harkema will answer 
any questions the research participant or family members may have in relationship to the 
research.   
 If the individual is potentially eligible for study and is interested in participation he/she 
will be seen by Dr. Camilo Castillo, for assessment of medical eligibility.  Dr. Castillo will 
complete a medical history and neurological examination to determine medical eligibility 
for each SCI research participant.  Dr. Castillo will discuss the risks and benefits with the 
potential research participant regarding the rehabilitative component. He will review all 
electrophysiological testing and training procedures that will be conducted during and 
explain to the potential research participant that s/he can refuse any of the procedures 

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and discontinue their participation at any time without penalty.  Dr. Castillo will answer 
any questions with the potential research participant and/or family members who may 
have a relationship with them regarding the physical rehabilitative aspects of the 
research.   
Dr. Boakye or Dr. Neimat will discuss the surgical protocols and the risks and benefits 
with the potential research participant. They will verbally review the surgical procedures 
and show the individual the stimulating and recording equipment that will be implanted.  
Dr. Boakye or Dr. Neimat will review all testing that will be conducted during the surgical 
procedures and explain to the potential research participant that s/he can refuse any of 
the procedures and discontinue their participation at any time without penalty Dr. Boakye 
or Dr. Neimat will answer any questions with the potential research participant and/or 
family members who may have a relationship with them regarding the surgical procedures 
and the research.   
Dr. Harkema will determine study eligibility based on the inclusion and exclusion criteria 
and in accordance with the medical recommendation of Drs. Castillo, and Drs. Boakye or 
Neimat. Dr. Harkema will also encourage potential research participants to read the 
informed consent and take several days to discuss participation with friends and family 
before agreeing to enter the study.  Drs. Harkema, Castillo, and Boakye will explain to the 
potential participant that the initial enrollment involves a series of pre-experiments and 80 
step/stand training sessions and the results are necessary to determine if they are an 
appropriate candidate for the surgical component of the study.  Participating in the initial 
portion of the study does not guarantee their eligibility for surgical implantation and 
epidural stimulation.   
The screening informed consent will be written in at an 8th-grade language level and 
will contain information on all evaluations to be performed as well as contact information 
should the research participant or his/her associates have any further questions.  The 
original signed informed consent and two copies will be kept in Dr. Harkema’s office. 
These individuals will not be concurrently enrolled in any other experimental studies 
unless approved by the principal investigator. Each research participant will be given a 
coded identification number to designate all evaluations.  We will retain the data for 
reporting to granting agencies even when the individual is not eligible for the study.  This 
data will be stored by the coded identification number without information identifying the 
individual.   
We will evaluate the research participants for: 1) functional neurophysiological 
assessment (FNPA); 2) somatosensory evoked potentials (SEP); 3) sympathetic skin 
responses (SSR); 4) efferent motor activity during standing; 5) efferent motor activity 
during stepping; 6) reflexes during supine, prone, sitting and standing; 7) bladder function; 
and 8) cardiovascular function. Each of these measurements will take between 1 and 4 
hours.  The FNPA, SEP and SSR will be performed while the research participant is lying 
supine on a mat.  The efferent motor assessments will be performed in the body weight 
support treadmill with the assistance of trainers at the hip and at each leg.   
 
We will assess metabolic parameters, inflammatory markers, complete blood count, bone 
density and health markers, blood glucose control and drug toxicity panel. A trained 

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technician will draw a venous blood sample. Participants may undergo a 12-hour fast the 
night before, including no food or drink including alcohol or caffeine (water is permitted). 
A comprehensive drug screen by urinalysis will be done to assess the use of illicit drugs. 
These blood and urine analyses may be repeated periodically throughout the course of 
the study.  A blood sample will be stored for batch processing at the end of the study (for 
participants that complete the screening process). 
After completion of these evaluations, participants will undergo 80 sessions of 
step/stand training. We will repeat experiments after the completion of the 80 training 
sessions to quantify that no motor pattern changes are achievable with locomotor training 
alone. Drs. Harkema, Castillo and Boakye will meet to discuss the results of the 
preliminary testing and evaluate if the participant is eligible for surgical implantation for 
SCES.   
 
FULL ENROLLMENT: Surgery + Epidural Stimulation + Training (2nd consent) 
If after evaluating the results, the study investigators determine that the participant is an 
appropriate candidate for surgery and epidural stimulation, the participants will be asked 
to sign an additional consent form.  The surgical and epidural stimulation informed 
consent will be written in at a 8th-grade language level and will contain information on the 
surgery and all experiments to be performed as well as contact information should the 
research participant or his/her associates have any further questions.  The original signed 
informed consent and two copies will be kept in Dr. Harkema’s office.    
The surgery will be performed at University Hospital to insert the epidural stimulating 
electrodes.  The lead wires will be tunneled subcutaneously to exit 5 centimeters from the 
incision site.  The implantable neurostimulator will be internalized and the connecting 
wires for the implanted electrodes will be tunneled under the skin and connected with the 
battery generator that will be placed in the abdominal area. We will repeat the experiments 
beginning at least 10 days after the surgery both with and without stimulation for 10 – 14 
days.  During the first two weeks after the surgery, the research participants may be 
hospitalized at Frazier Rehab Institute to monitor the incision site.  We will also identify 
appropriate stimulation parameters for inducing stepping and standing in combination 
with manual assistance using body weight support on a treadmill (BWST).   
Following discharge from inpatient or recovering at home the individuals will be seen in 
our lab on a daily basis for testing and locomotor training.  We will evaluate the 
combination of epidural stimulation with manual step/stand training. This stage will be 
conducted over six-eight months. During training, the patients will be provided with 
epidural stimulation using the parameters defined in Stage 1. Testing may be performed 
weekly. The blood samples for metabolic parameters may be repeated prior to and after 
each training period.  A blood sample will be frozen and stored in the laboratory for batch 
analysis for inflammatory markers, metabolic parameters, and markers for bone density. 
 
Locomotor Training: Every research participant will be slowly acclimated to the body 
weight support system to make him/her feel comfortable in an upright position.  This may 
help the research participant avoid experiencing a lowered blood pressure or dizziness.  
However, if these conditions should occur, the research participant would immediately be 

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unhooked from the system, removed from an upright position, the legs elevated, and the 
blood pressure monitored.  Stepping bouts are relatively short in duration, thus an 
increase in respiration as well as an increase in heart rate or blood pressure will generally 
last for only a couple of minutes.  Each research participant will be closely monitored 
through each experiment and training session.  Standing or stepping will immediately halt 
once the research participant feels tired or winded.  Blood pressures and heart rates will 
be monitored by the physical therapist or trained staff regularly during each training 
session. Continuous blood pressure, breathing rate, and temperature may be monitored 
with sensors throughout the training sessions and experiments. Participants may be 
asked to train twice a day; they will train both to stand and step on the same day. The 
sessions will only be counted if the progression criteria is met, for example independence 
minutes or weight-bearing minutes. 
In certain cases, the physician, Dr. Camilo Castillo, might recommend a specific training 
change or limit on sessions to mitigate risk for research participant. Any special 
considerations are specified in the addendum section. 
Before and after every experiment and training session, a physical therapist or research 
staff member will examine the research participant’s skin for irritations and abrasions.  If 
skin irritations or abrasions are caused by the electrodes, harness position or hand 
placements of trainers, electrode, the harness and hand placement will be modified 
appropriately.  Further, the physical therapist and research team will constantly monitor 
the research participant’s skin and muscle for signs of muscle strain, joint sprain and skin 
irritation (e.g. temperature and redness). 
Dr. Harkema and the research team will continually assess the appropriate BWS and 
continuously monitor manual assistance by trainers to avoid joint sprain and fracture.  
Body weight support will be kept above 50% for the initial sessions to allow bone and 
muscle to become stronger. Further, continuous monitoring of the research participant 
will be conducted by the staff for potential injuries.  For example, signs of skin redness, 
swelling of joints, or spasticity can be indicators of injury when research participants have 
impaired sensation.  Research participants will also be stretched by the physical therapist 
or trained staff member before and after each training session to prevent injury. 
If any signs of risks or discomfort are noted, the experiment or training session will be 
immediately discontinued.  If any complications arise, the stand or step training will 
immediately stop and Dr. Castillo will immediately be informed.  In addition, the research 
participant’s primary care provider will be notified as necessary.  Dr. Castillo will be the 
medical advisor for the research participants throughout the locomotor training segment 
of this study.  Dr. Boakye or Dr. Joseph Neimat will oversee all surgical related issues for 
the research participants.  
Follow-up: After the training period has ended, patients will be followed up by Drs. 
Boakye/Castillo and Harkema every three-six months for a total of three years following 
surgery. After three years the patients will be followed up by Drs. Boakye/Castillo and 
Harkema every six months for continued long-term care until the device is explanted or 
the device is approved for stepping and standing in spinal cord injury. Follow-up 
neurological examination for the purpose of this study will be incorporated into each clinic 

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visit. The decision to continue to maintain the stimulators or remove them will be made 
during these follow-up visits. 
Dr. Harkema and the research team might ask the participant to return for training in the 
laboratory for extended periods of 80-200 sessions post participation in the original 
sessions. Training (stand or step) will be designed to optimize parameters and built to 
improve on previous training. During this time participants might be asked to functional 
train with the combination of our adaptive epidural stimulation strategy with manual 
locomotor training. During training, the participants will be provided with ES using the 
parameters determined using the computation learning method which is developed during 
phase 2 described below.  
 
 
E. How the study population is determined and how they will be equitably recruited 
There are approximately 250,000 Americans with a SCI.  Of this population, 82% are 
male.  Fifty-six percent of the injuries occur in people between the ages of 16 and 30, and 
the average age of an individual who has sustained a SCI is thirty-one.  Thirty-eight 
percent of the research participants studied will be derived from a population of minorities 
(African-American, American Indian or Alaskan Native, Asian, Hispanic or Latino, and 
Native Hawaiian or other Pacific Islander).  Every effort will be made to recruit women, 
though only about 18% of SCI patients are female.  Although many people after a SCI 
have secondary health issues such as spasticity and frequent urinary tract infections, they 
are otherwise healthy individuals.  Standing and stepping is considered beneficial for 
people with SCI who are confined to a wheelchair, as immobilization can contribute to 
secondary pathologies such as osteoporosis, leg muscle contractures, decreased 
cardiovascular health, pressure sores and muscle atrophy.  Children will not be studied.   
Pregnant women with SCI will not be studied because the risks to the fetus are unknown.  
No other vulnerable research participants will be included.   
Research participants will be identified by Drs. Harkema, Castillo, and Boakye. 
Physicians and physical therapists at rehabilitation sites in the Louisville area will be 
provided with the purpose of research, selection criteria for referral, and flyers for 
advertisement.  Further, we currently have a database of approximately 2000 potential 
SCI research participants matching the eligibility requirements who have expressed 
interest in participating in our research program (UofL IRB# 06.0647).  The research aims 
and a summary of the criteria for eligibility will be posted on Dr. Harkema's website.  We 
will also post flyers for advertisement to recruit individuals throughout the university.  
Flyers with a description of the study and a telephone number to call to express interest 
will be made available to potential research individuals.   
  
F. Eligibility (inclusion) and exclusion requirements for research participants 
 
In this pilot study, we will recruit ten research participants within a ten year period who 
have sustained a SCI to participate in this first phase of the study, i.e. using only 
conventional electrodes. Currently, there is no known treatment for patients with 
functionally complete spinal cord injury for the recovery of standing and walking.  In this 

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study we hope to develop a treatment that will provide patients with the ability to stand 
and walk. Dr. Harkema’s center routinely performs locomotor training that has shown to 
benefit some patients with spinal cord injury. Placement of a dorsal column stimulator in 
the lower thoracic- lumbar area of the spinal cord is well accepted and a commonly 
performed operation by neurosurgeons for treatment of chronic intractable pain in the low 
back and legs. Thus, both procedures combine standard treatment strategies, but this 
study investigates the potential expansion of both these therapies to more severely 
injured patient population. We are not aware of any other treatment that will provide such 
improvement in function. If this treatment is successful, it is anticipated that patients’ 
locomotor function would improve to the point of the research participant being able to 
stand or walk with a walker or a cane. This study will evaluate potential gains in addition 
to those which occur following electrical spinal cord stimulation.  
All research participants, irrespective of age or sex, will meet the following criteria: 1) 
stable medical condition without cardiopulmonary disease or dysautonomia that would 
contraindicate standing or stepping with BWST; 2) no painful musculoskeletal 
dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that 
might interfere with stand or step training; 3) no clinically significant depression or ongoing 
drug abuse; 4) no current anti-spasticity medication regimen; 5) non-progressive SCI 
above T10; 6) must not have received botox injections in the prior six months; 7) be 
unable to stand and step independently overground; 8) unable to voluntarily move all 
individual joints of the legs; 9) at least one-year post injury; and 10) must be at least 18 
years of age. In addition, all subjects must satisfy each of the three conditions of the 
functional neurophysiological assessment described below. 
Additionally, research participants with the following characteristics will not undergo any 
assessments using transcranial magnetic stimulation (TMS): 1) metal in head  (except 
mouth) such as but not limited to cochlear implant, implanted brain stimulators, aneurysm 
clips; 2) increased intracranial pressure (which lowers seizure thresholds);  3) cardiac 
pacemakers;  4) implanted medication pumps; 5) intracardiac lines; 6) significant heart 
disease; 7) history of stroke or other brain lesions; 8) personal or family history of epilepsy; 
9) receiving tricyclic antidepressants or neuroleptics (which lower seizure threshold); 10) 
heavy alcohol consumption within past 48 hours  
 
Functional Neurophysiological Assessment (FNPA). We will use FNPA to screen 
potential research participants based on specific neurophysiological inclusion criteria. 
Participants must have no volitional control of movement below the level of the lesion, but 
must retain some brain influence on spinal reflexes. Our target population, which will be 
identified by FNPA, cannot be identified reliable using traditional assessments: hence 
individual subjects may be classified widely as Class A, B, or C on the ASIA SCI scale. 
We will include only subjects who fulfill the following three requirements: 
1. There is no descending volitional control of movement below the lesion 
2. Segmental reflexes remain functional below the lesion 
3. Brain influence on spinal reflexes is retained 
 
G. Design/methodology including all survey instruments, questionnaires, etc.  

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SCREENING CONSENT: 
Stage 1A: Standing and stepping interventions 
FULL ENROLLMENT CONSENT: 
Stage 1B: Surgical Procedure 
Stage 1C: Stimulation procedures and standing and stepping interventions 
Stage 2A: Stimulation procedures and standing and stepping assessments 
Stage 2B: Adaptive Multielectrode Epidural Stimulation and Locomotor 
Training 
 
Stage 1A: Standing and stepping interventions 
Prior to the initial surgery the participant will undergo 80 sessions of step/stand training 
(screening). We will evaluate the research participants with the following experiments: 1) 
functional neurophysiological assessment (FNPA); 2) somatosensory evoked potentials 
(SEP); 3) sympathetic skin responses (SSR); 4) efferent motor activity during standing; 
5) efferent motor activity during stepping; 6) reflexes during supine, prone, sitting and 
standing before the initiation of training; 7) bladder function; 8) cardiovascular function; 9) 
MRI Scan; 10; Quality of life questionnaires.   Each of these measurements will take 
between 1 and 4 hours.  We will repeat these measurements at the end of the initial 80 
training sessions. Participants will undergo laboratory tests to assess and reduce the risk 
of infectious diseases prior to surgery.  
 
 
 
 

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Protection against Infectious Diseases: Several lab tests (see table below) will be 
performed to assess the risk of infection prior to surgical implantation based on the 
recommendation from the Infection Prevention and Control Department (ULH) and 
Division of Infectious Diseases, Dept. of Medicine (UofL). Dr. Castillo will oversee 
treatment for any positive urine culture and infections in consultation with the Division of 
Infectious Diseases Department.  
 
Test 
Purpose 
When 
Nasal swab for MRSA 
To determine if colonized 
to decolonize and use 
vancomycin as pre-
operative antibiotics 
Approximately 4 weeks 
prior to scheduled 
surgery to allow for time 
for treatment, re-test + 
treatment and final re-
test. 
 
Peri-rectal swab for 
MDRO Gram-negatives 
To determine if colonized 
and, based on organism, 
consider decolonization 
and adjustment of pre-
operative antibiotics 
urinalysis 
To identify infection for 
clearance prior to 
procedure 
Within 30 days of 
scheduled surgery; may 
need to be repeated 
closer to surgery date 
urine culture 
C-reactive protein (CRP) 
To obtain for baseline 
measure 
Erythrocyte 
sedimentation rate (ESR) 
Procalcitonin 
Prealbumin/Transthyretin 
To verify appropriate 
status for procedure 
Albumin (included in 
CMP) 
25-Hydroxy Vitamin D 
CBC with differential 
CMP 
Pregnancy Test 
 
If a patient tests positive for MRSA, de-colonization will be recommended and monitored 
by the infectious disease team in collaboration with Drs. Castillo and Boakye. Treatment 
plan includes the following to be administered for 7 days: chlorhexidine gluconate (2 or 
4% solution) with daily washes or a disposable impregnated cloth; mupirocin ointment 
(2%) applied to the nares with a cotton-tipped applicator two to three times daily. 
Following initial treatment, the participant will be retested for MRSA. If the participant still 
tests positive then treatment will include repeated decolonization as well as the following: 
rifampin (600 mg PO daily) plus either doxycycline (100 mg twice daily) or 
trimethoprim/sulfamethoxazole (one double strength twice daily). The participant will be 
retested following this second treatment. If the participant still tests positive then they 

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should be excluded from the study. The physicians will manage the medical treatment for 
infections and for any immediate safety concerns. 
 
Stage 1B: Surgical Procedure 
 
One Medtronic Specify 5-6-5 or Specify 5-6-5 SureScan MRI (Minneapolis, MN) 
16-electrode epidural arrays will be implanted intraoperatively using a single surgery 
procedure. The surgery will be conducted at University Hospital under a combined 
regional and general anesthesic. General anesthesia will be utilized for part of the surgery 
and mild sedation for the other part. We do not anticipate that the patients will experience 
any pain during this operation. However, if there is any discomfort, the patients will be 
administered analgesics by the anesthesiologist and/or the painful area will be infiltrated 
with local anesthetic. Patients will be placed in the prone position with an incision made 
in the thoracolumbar area of the spine. We will perform a partial laminectomy at the T11–
T12 interspace providing a site for electrode insertion. The incision will be approximately 
2.0 – 2.5 inches. One electrode will be threaded upwards to the T11-L1 segmental levels. 
If necessary the second electrode will be threaded downward to the S1-S2 segmental 
levels for placement over the group of spinal cord nuclei where activation of the muscles 
occurs. Fluoroscopy and neurophysiological parameters will be used to determine the 
optimal lead placement that will be determined by motor system monitoring.  
Following the location of optimal lead(s) placement the participant will be rolled to 
the lateral decubitus position and the surgeon will proceed with the internalization of the 
implantable neurostimulator into the subcutaneous area of the abdomen. The wires of the 
implanted epidural electrodes will be tunneled under the skin and connected with the 
battery generator that will be placed in the abdominal area.   
We do not anticipate any increased risks other than the well-recognized accepted 
risks of surgery (infection, bleeding, and anesthesia).   
1) Infection: To minimize risks of infection participants will take a chlorhexidine bath one 
week prior to surgery at home, and the day of surgery in the hospital by a nurse.  All 
neurophysiological equipment will be disinfected with PDI® Sani-cloth AF3 germicidal 
disposable wipes prior to entry in the OR. Access to the OR will be limited during the 
entire surgical procedure with restricted access through the sterile core. Only essential 
personnel will be permitted in the OR. Each participant will be administered intravenous 
antibiotics throughout the operation and for 48 hours postoperatively. Vancomycin 
powder will not be initially recommended, however we will use a TYRX™ Neuro 
Absorbable Antibacterial Envelope in the abdominal pouch site for the battery generator.  
In the unlikely event of an infection, the patient may require prolonged intravenous 
antibiotics, reopening of the incision to irrigate and drain an abscess, or even removal of 
the epidural electrodes.  
2) Hemorrhage: Scrupulous attention for hemostasis should prevent a postoperative 
hematoma from occurring. However, if a hematoma develops and is clinically significant, 
timely surgical evacuation of the clot will be performed.  
3) Anesthesia: Patients will be induced by general anesthesia and once the incision if 
opened and epidural electrodes placed, the optimal placement of the electrodes will be 
confirmed with electrophysiological assessments by inducing monosynaptic reflexes and 

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monitoring their latency and amplitude from surface EMG electrodes from the 
quadriceps, hamstrings, adductor, gluteus maximus, tibialis anterior and triceps surae, 
bilaterally. Fine-wire EMG electrodes will also be used to monitor the Illio-psoas muscle. 
The patients will be closely monitored by the anesthesiologist for changes in blood 
pressure, pulse, and temperature with appropriate treatment will be instituted should 
alterations of these parameters be observed.  
 
Stage 1C: Stimulation procedures and standing and stepping interventions 
We may repeat experiments that were performed pre-surgery beginning 2 weeks 
after the surgery both with and without stimulation for 10 – 14 days.  During the two weeks 
after the surgery, the research participants may be hospitalized at Frazier Rehab Institute 
to monitor the incision site.  
Optimal configurations will also be tested for bladder and cardiovascular function. 
A specific stimulation parameter may be used to assess the influence of epidural 
stimulation on bladder function and/or cardiovascular function. In the case of bladder 
function, following its assessment with stimulation the bladder will be filled with saline 
solution a second time after a 5 minute break. The optimal stimulation configuration for 
bladder will be used and the pressure will be recorded. The individual will be asked to 
attempt to empty his/her bladder when the stimulation is ongoing. Pressure will also be 
recorded when the bladder is relived. This test will take approximately 60 minutes. 
Similarly the cardiovascular function might be assessed without and with stimulation. The 
orthostatic stress test (sit up test) might be repeated with optimal stimulation for 
cardiovascular control. The butterfly catheter will remain in place from the initial non 
stimulation test and blood samples will be obtained to same time points to assess if any 
changes in  
We will also identify appropriate stimulation parameters for inducing voluntary 
activity and stepping and standing in combination with manual assistance using body 
weight support on a treadmill (BWST) or overground.  Each of the sixteen electrodes will 
be independently stimulated using subthreshold, tonic, non-patterned epidural stimulation 
applied at frequencies of 5-50 Hz, and amplitudes of 1-10 V.  The specific stimulation 
parameters will be optimized for each individual to achieve the best motor performance 
for each task.  We may monitor continuous blood pressure, breathing rate and 
temperature using external sensors pasted over the skins during training sessions or 
experiments.  
 
Stage 2A:  Stimulation procedures and standing and stepping assessments 
Following post-surgery experiments, training will be conducted 5 times per week 
for 160 sessions on an outpatient basis. In Stage 2 the individuals will be seen in our 
laboratory  on a daily basis for testing and training. After the initial 20 sessions of training, 
they might be asked to come train twice a day (stand and step on the same day) with a 
2-4 hour resting period in between.  We will evaluate the combination of epidural 
stimulation with manual step (locomotor) training. This stage will be conducted over four 
to eight months. Periodically, blood and urine samples may be collected, processed for 
testing as described above, and stored for batch testing at the end of the study period. 

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During training, the patients will be provided with epidural stimulation using the 
parameters defined in Stage 1.  
In certain cases, the physician, Dr. Camilo Castillo, might recommend a specific 
training change or limit on sessions to mitigate risk for research participant. Any special 
considerations are specified in the addendum section. 
The participants may be evaluated weekly for 1) efferent motor activity during 
standing and stepping and 2) reflexes during supine, prone, sitting and standing, as 
described above.  
Home Training: Following the determination of optimal parameters for standing or 
voluntary activity, the participant might be given a Patient Programmer (Medtronic Model 
37743) to translate weight bearing and stand training and/or voluntary movement with 
stimulation to the home environment and perform additional training. The programmer will 
be optimally programmed by the research team in such a way to restrict configuration 
changes by research participant. A pre-determined range of optimal voltages will be 
accessible by the research participants. A very specific protocol for stimulation and 
training will be given by the research team and the participant will be required to complete 
a training log. The research team will collect the home training log from the participant 
once a week and evaluate the need for changes to the home-based training protocol. 
 
Stage 2B: Adaptive Multielectrode Epidural Stimulation and Locomotor Training 
Stage 2 will evaluate the combination of our adaptive epidural stimulation strategy with 
manual step (locomotor) training. During training, the participants will be provided with 
ES using the parameters determined using the computation learning method in Phase 1.  
 
Experimental materials.  
We will acquire lower extremity and trunk muscles surface EMG activity and kinematics 
bilaterally during all experimental conditions. We will also use fine-wire EMG to acquire 
activity from the illio-psoas, extensor hallicus longus, extensor digitorum longus and other 
deep muscles muscle.  We will also record individual limb loading and level of BWS during 
standing and stepping conditions.  We may acquire continuous blood pressure with a 
finger cuff, breathing rate using an elastic band place loosely around their chest and 
temperature with 1-3 small sensors taped over their skin above and below their injury 
level. 
 
Locomotor Training Intervention.  
 Individuals with SCI will participate in 80 sessions of weight bearing step-training (n=10) 
for approximately 16 - 20 weeks (60-90 minutes/session, 3-5 sessions/week) during 
which the individuals may be placed on the treadmill in an upright position and suspended 
by an overhead pulley (Innoventor, St. Louis, MO) in a harness (Robertson, Hendersen, 
NV). During stepping using BWST and manual assistance the maximum load will be used 
that avoids knee-buckling and trunk collapse [64].  A trainer positioned behind the 
research participant will aid in pelvis and trunk stabilization, as well as weight shifting and 
hip rotation, and trainers positioned at each limb will provide manual assistance using a 
customized technique that facilitates knee extension during stance (by manually 

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stimulating the patellar and Achilles’ tendons) and knee flexion and toe clearance during 
swing (by manually stimulating the hamstrings and tibialis anterior tendons).  Trainers 
provide assistance only when needed.  Individuals will step at a normal walking speed for 
their height and age (0.89 m/s – 1.34 m/s) and at the maximum body weight allowed with 
minimal force needed by the trainers to assist during stance (4, 25). Body weight support 
will be continuously reduced over the course of the 80 sessions as the individuals 
increase their ability to bear weight on the legs during stepping. Step training sessions 
might progress to the overground environment when appropriate.  
Participants may also stand train in a stand training device, based on optimal 
parameters acquired during the initial phase of training. The participant might be asked 
to follow a supine and/or stand training home program (in a standing frame or similar 
device) once independence is achieved with the stimulation. The home program will only 
be used as a complement to the daily outpatient training sessions, and will be closely 
monitored by the research team. The research participants will have to demonstrate 
independence and safe use of the patient programmer in the lab prior to initiation of the 
home program. Parameters loaded in the patient programmers will only include those that 
have been used safely and result in supine movements or independent standing by the 
research participant in the laboratory setting. In addition, family members and caregivers 
will be trained on appropriate techniques to provided assistance as needed during home-
based training. Independent standing and availability of caregivers to provided assistance 
in the home environment will be key factors when developing the home program.  
 
We will collect electromyography (EMG), joint angle, and footswitch data at 1000 Hz 
using a 24-channel hard-wired analog to digital board and a custom written Labview 
software acquisition program (National Instruments, Austin, TX) during stepping using 
BWST or overground and manual assistance.  EMG data will be sampled from 0.1 to 1 
kHz and AC coupled into a differential amplifier (Konigsberg Instruments, Pasadena, CA).  
Following standard skin preparation, bipolar surface EMG electrodes with a fixed distance 
between the electrodes will be placed on the soleus, medial gastrocnemius, tibialis 
anterior, medial hamstrings, adductor, vastus lateralis, and rectus femoris bilaterally.  
Limb kinematics will be digitally acquired a passive marker high speed motion capture 
system (Motion Analysis, Santa Rosa, CA).  Individual limb loads will be measured with 
shoe-insole pressure sensors (FSCAN, Tekscan, Boston).  Data will be processed and 
synchronized using Labview software (National Instruments, Austin, TX) customized by 
our laboratory.  EMG data will be full wave rectified and filtered using a 4th order 
bandpass Butterworth filter (40 Hz - 500 Hz).  Mean EMG represents the relative number 
and frequencies of the motor units recruited per burst.  Integrated EMG assesses the total 
EMG activity generated per step.  EMG mean and integrated amplitudes from each 
muscle will be compared before and after locomotor training.  Co-activation values of 
flexors and extensors will be calculated. The degree of coordination in the stepping-
related oscillations of lower limb segments will be assessed through principal component 
analysis.  Quantitative measurements and statistical testing have been described in detail 
in previous publications listed above.   

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Heart rate will be monitored using a digit pulse oximeter placed on the index finger of 
the research participant during training sessions and experiments. 
 
Next analytical approaches will be utilized in these studies: 
• EMG burst cycle analysis. EMG signals will be band pass filtered between 40-500 Hz to 
eliminate any transient signals and then rectified. A minimum threshold for EMG activity 
(3 standard deviations (SD) above mean baseline noise) will be selected for each 
channel. Onset of EMG bursts is detected as the location where the signal amplitude 
remains above the threshold for 50 continuous samples, and the end as the location 
where the signal amplitude remains below the threshold level for 150 continuous samples. 
Detected start and end points are displayed as marks on the data for verification. Mean 
EMG (MEMG) may be used to make interpretations about the relative number and firing 
frequencies of the motor units recruited per burst. Integrated EMG (IEMG) assesses the 
total EMG activity generated per step.  
• Muscle co-activity and clonicity. We developed a method to quantify the clonicity of and 
coactivation among muscles during human locomotion based on a Bayesian approach to 
EMG analyses, using reversible jump Markov chain Monte Carlo (RJMCMC) simulation 
(Harkema et al. 1997). In Bayesian analyses, data are passed through a simulation 
algorithm multiple times (300,000), generating distributions of the quantities of interest. 
The Bayesian process yields an objective assessment of the mean and deviation of 
parameters of a signal (in this case co-activity and clonicity), thereby, minimizing research 
participative error. Further, the measures vary less than 0.5% after repeating the 
measures three times across five data sets. This approach allows for statistically valid 
inferences about these quantities and the differences between them.  
• Linear envelopes. The high-pass filtered and rectified EMG data will be low-pass filtered 
at 5 Hz. EMG bursts may be averaged relative to the start of a burst in the muscle, the 
start of a burst in another muscle, or to a biomechanical event such as the rise or decline 
of force. Averages will be generated from data normalized to the duration of each burst 
or step cycle. Averaged waveforms are of interest because they may be assumed to 
represent the typical activity pattern. Coefficients of variation will be calculated to scale 
standard deviations to a mean value throughout the step cycle.  
• Scatter plots. Scatter plots will be used to detect relationships among muscle EMG, limb 
loading, stepping velocity, and joint position. Scatter plots will be generated from 
individual steps and averaged waveforms. EMG amplitudes (5 Hz low pass filtered) of 
agonist and antagonist muscles will be plotted (triceps surae (TS), tibialis anterior (TA), 
hamstring (HM), quadriceps (Q), and adductor (ADD) to assess muscle coordination. This 
provides information about the phasing of a muscle activity relative to other muscles. The 
relationship between EMG activity and either phases of loading or joint position will also 
be plotted. Three-dimensional relationships incorporating two of the latter variables and 
muscle EMG will also be utilized.  
• Voluntary response index. Voluntary motor task EMG from healthy individuals has been 
averaged across a five second window to generate response vectors (RVs). The 
prototype response vector (PRV) was generated by normalizing the RVs by the vector 
magnitude and then averaged. The PRV is comprised of 10 elements, one for each 

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muscle. A PRV is created for each phase of each movement in the voluntary motor task 
component of the BMCA protocol. A similarity index (SI) is then used for comparison of 
the data. The SI is a numerical expression of the similarity of the distribution of the EMG 
activity in the RV, computed as the normalized dot product between the two vectors 
(vector representing the distribution of activity generated by healthy research participants, 
and that representing the distribution of activity in the test research participant). A value 
of 1.0 for the SI represents an identical distribution.  
 • Kinematic and kinetic analysis. Joint kinematics will be analyzed using EVaRT and 
Orthotrak which provide instantaneous 3-D graphic displays and all kinematic parameters 
of the motion performed by a research participant. The force signals will be acquired from 
FSCAN at 50 Hz and interpolated to 1000 Hz and low-pass filtered (5 Hz). A minimum 
threshold (3 SD above baseline) will be calculated for each signal. BWS was acquired by 
Labview A/D and processed by customized software.  
 
These results will reveal whether conventional electrodes can be used to facilitate 
stepping in clinically complete spinal cord injury patients. This study will clarify whether 
the optimal spinal cord sites for using epidural stimulation to induce stepping and standing 
migrate over the course of training in the human spinal cord. We expect that these data 
will provide further evidence of the plasticity of the injured spinal cord, and that training 
modifies the spinal networks for stepping. Stepping performance of the patients will be 
compared against historical controls that were given step training without epidural 
stimulation. The criteria for success of the combined treatment will be determined by the 
best outcomes that have been obtained for previous patients who were only trained. 
 
 
h. Treatment regimen(s) (for medically invasive research) 
 
 
i. Clinical information (when applicable) (for medically invasive research) 
 
 
j. Statistical analysis of the collected data 
 
No statistical analysis will be used for comparison of data.  This study is 
designed as a proof of principle study without statistical power to demonstrate the 
feasibility of the methods. 
 
 
k. Data and Safety Monitoring Plan 
 
 
Entity responsible for monitoring is identified: 
The study will be monitored by a Data Safety Monitoring Board consisting of: Dr. 
James Guest (Neurosurgeon), Dr. Steven Kirshblum (physiatrist); Dr. Steve 

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Schulman (cardiologist) and Dr. Thomas Kessler (Urologist) who are not associated 
with the study.  
 
Policies and procedures for adverse event reporting are described: 
If a subject develops an adverse event it will be reported to the DSMB, local IRB 
and Sponsor within 24 – 48 hours of being notified of the event. 
 
Protocol Compliance:  
Any deviations in the protocol will be documented and reported to the IRB. 
 
Plans for measuring appropriate intervals between safety reviews and 
predetermined criteria for stopping the study: 
Research participants will be continuously monitored for complications, adverse 
events and/or serious adverse events.  If any complications arise during the course 
of the study the local Medical Advisor (Dr. Castillo) will be notified.  All study 
procedures will be halted until the complication, adverse event and/or serious 
adverse event has been reviewed by the medical advisor and it has been 
determined that it is safe for the study participant to return to participating in study 
procedures. 
 
If a serious adverse event occurs and is related to the study product all study 
procedures will stop.  AE’s and SAE’s will be reported to the Medical Advisors, 
Medical Monitor, IRB and Sponsor. 
 
Plans to ensure NIBIB/NIH is informed of actions taken by the IRB: 
All correspondence with the IRB will be forwarded to the sponsor. 
 
Reports of revisions or amendments to the Protocol: 
All revisions and amendments to the Protocol will be sent to the sponsor and IRB.  
No study procedures will be conducted without IRB approval. 
 
m. Investigator’s Brochure for drugs or devices - The IRB is required to examine the 
Investigator’s Drug Brochure and/or device guide in order to adequately assess the 
risk/benefit ratio for research participants participating in the research. 
 
 
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DJ, Roy RR, Talmadge RJ, Tillakaratne NJ, Timoszyk W, Tobin A (2001) Topical 
Review: retraining the injured spinal cord. J Physiol 533:15-22 
 64.  Harkema SJ, Hurley SL, Patel UK, Requejo PS, Dobkin BH, Edgerton VR (1997) 
Human lumbosacral spinal cord interprets loading during stepping. J Neurophysiol 
77:797-811 

IRB# 07.0066: Spinal Epidural Electrode Array to Facilitate Standing and Stepping after Spinal Cord 
Injury 
 
Version date: 08/08/2017  
Page 23 of 24 
65.   Gerasimenko YP, Ichiyama RM, Lavrov IA, Courtine G, Cai L, Zhong H, Roy RR, 
Edgerton VR (2007) Epidural spinal cord stimulation plus quipazine administration 
enable stepping in complete spinal adult rats. J Neurophysiol 98: 2525-2536. 
66.   Courtine G,Gerasimenko YP, van den Brand R, Yew A, Musienko P, Zhong H, 
Song B, Ao Y, Ichiyama RM, Lavrov IA, Roy RR, Sofroniew MV, Edgerton VR 
(2009)  Transformation of nonfunctiona spinal circuits into functional states after 
the loss of brain input. Nature Neurosci 12: 1333-1344 
67. Biering-Sørensen F, Charlifue S, DeVivo M, Noonan V, Post M, Stripling T, Wing P. 
International Spinal Cord Injury Data Sets. Spinal Cord. 2006 Sep;44(9):530-4 
68. Rossi S, Hallet M, Rossini P, Pascual-Leone A, The Safety of TMS Consensus 
Group. Safety, ethical considerations and application guideline for the transcranial 
magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 
Dec;120(12):2008-39. 
 
 
 
 
 

IRB# 07.0066: Spinal Epidural Electrode Array to Facilitate Standing and Stepping after Spinal Cord 
Injury 
 
Version date: 08/08/2017  
Page 24 of 24 
Addendum 1 
 
 
Recommendation for training interventions to mitigate risk of a research participant that 
has sustained a hip fracture: 
 
Prior to a participant resuming step and stand training medical clearance will be 
obtained from their treating orthopedic surgeon.   
 
Stand Training with stimulation will occur for the initial 40 sessions. No step training will 
occur during this time.  Following the initial 40 sessions and clearance from study 
physician, the participant will resume study stand/step interventions with stimulation.  
Participant might be ask to complete an additional 160 sessions of combined training to 
reduce the variability at the assessment points. Assessments might be repeated after 
the initial 40 stand training sessions and then at various points following the initiation of 
standing and stepping. The research team will follow all procedures as specified in the 
protocol. 
 
In regard to the evaluation of these results, in all publications the number of training 
sessions will be reported accurately.  Given the high number of training sessions these 
individuals received, the variability in this research participant is not expected to 
significantly affect the outcome.  However, this change in protocol will be considered in 
the interpretation of any results. In addition, additional assessments will provide 
information relevant to the interpretation. 
 

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 1 of 13
Version: 09/13/17 
INFORMED CONSENT AND RESEARCH AUTHORIZATION 
SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING 
IN SPINAL CORD INJURY
Industry Contracts number: 
070943Y02; 080483 and 111096
Grants number: 
1R01EB007615-01A1
Sponsor(s) name & address: 
National Institutes of Health
P.O. Box 5801, Bethesda, MD 20824
Christopher and Dana Reeve Foundation
636 Morris Avenue, Short Hills, NJ07078
Kessler Foundation
300 Executive Drive, Suite 70, West Orange, NJ 07052-3390
The Leona M. and Harry B. Helmsley Charitable Trust
230 Park Avenue, Suite 659, New York, NY 10169
Investigator(s) name, Degree, University Department, & address:
Susan J. Harkema, Ph.D.
Department of Neurological Surgery
220 Abraham Flexner Way, 15th Floor
Louisville, KY 40202
Camilo Castillo, M.D.
Assistant Professor and Director of Spinal Cord Injury
Frazier Rehab Institute
220 Abraham Flexner Way
Louisville, KY 40202
Site(s) where study is to be conducted:
Neuroscience Collaborative Center
University of Louisville, KY 
Department of Neurological Surgery, Louisville, KY
University of Louisville Hospital
Phone number for subjects to call for questions: (502) 581-8675
Introduction and Background Information
You are invited to take part in this research study because the results of the screening process have shown 
that you are eligible for participation. This study involves a non-indicated use of a FDA approved device and 
the manufacturer has not completed testing with the device as it will be used in this study. The study is being 
conducted by Dr. Susan Harkema, Dr. Camilo Castillo, Dr. Maxwell Boakye and Dr. Joseph Neimat. The study 
is sponsored by the National Institutes of Health, Christopher and Dana Reeve Foundation, Kessler 
Foundation, the Leona M. and Harry B. Helmsley Charitable Trust and the University of Louisville, Department 
of Neurological Surgery and will take place at the University of Louisville, University Hospital and the Frazier 

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 2 of 13
Version: 09/13/17 
Rehab Institute in Louisville. Approximately 10 individuals with spinal cord injury will be invited to participate in 
this study. Your participation in this study will last for approximately 3 years. After 3 years a decision will be 
made as to whether the spinal stimulator will be left in place or removed. If the stimulator is beneficial, it will be 
left in place. If ineffective, a decision will be made to keep the stimulator in place or remove it. Long term 
follow-up after 3 years will consist of visits to the clinic every 6 months at no cost to you until the device is 
removed or the device is approved by the FDA. If you are pregnant, anticipate pregnancy or are nursing you 
are not eligible to participate in this study.
Purpose
The purpose of this research study is to investigate the combined effects of stand and step (locomotor) training 
with electrical stimulation of the spinal cord in patients who have had a complete spinal cord injury. We hope to 
show that this treatment will increase the muscle strength in your extremities. It is known that patients with a 
severe spinal cord injury are able to be trained using locomotor training. Locomotor training is a process to 
develop activity in the nerves and muscles of patients with a spinal cord injury during standing and stepping 
with assistance from people. As well, electrical stimulation of the spinal cord following spinal cord injury in 
animals demonstrates a walking-like motion. The information learned in this study will be used to find the best 
conditions to assist patients to stand and walk using electrical spinal cord stimulation and locomotor training. 
The patient in a research study is called a subject.
Procedures
You will undergo locomotor training, a recognized method to enhance standing and walking following spinal 
cord injury, under the supervision of Dr. Harkema at the University of Louisville. In discussion with Drs. Boakye 
or Neimat, and Dr. Castillo, and Dr. Harkema, you have been considered to be eligible to enter this study.
1.
Experiments
We will test the activity of your leg muscles during resting conditions and while you are standing or 
stepping (overground or with body weight support) with the help of trainers who will be moving your 
legs. In all of these experiments, there will be sensors pasted to your skin to record the electrical 
activity of your arm and leg muscles. During the motor testing experiments we may use a needle to 
insert a fine wire in muscles in each leg to record the electrical activity. Other sensors pasted to the skin 
will record the position of your legs, and sensors placed inside your shoes will record the amount of 
weight on your legs. We may measure continuous blood pressure, breathing rate and temperature  with  
different  sensors  during  any  of  the  experiments  or  training  sessions. We will videotape how you 
stand and step. You will have the opportunity to rest at any time during any of these experiments. We 
will ask you to participate in these experiments throughout the study.
a.
Functional NeuroPhysiological Assessment
i.
In this test you will be lying down on your back and we will ask you to move your legs.
ii.
This test will take approximately 1 hour to perform.
b.
Somatosensory Evoked Potentials
i.
We will apply an electrical current over the on your wrists and ankles.
ii.
Devices maybe pasted to your skin to record the electrical activity of your muscles during 
the stimulation.
iii.
You will wear a cap with electrodes that will touch your scalp to record your brain activity.
iv.
This test will take approximately 1 to 2 hours to perform.

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 3 of 13
Version: 09/13/17 
c.
Sympathetic Skin Responses
i.
We will test the amount of sweat in your hands and feet after providing a low level of 
electrical stimulation over one of the nerves in your arm, leg and forehead.
ii.
This test will take approximately 1 hour to perform
d.
Motor Testing
i.
You will be helped to stand or step on a treadmill while wearing a harness that is attached to 
an overhead suspension device which will support the weight of your body.
ii.
If standing or stepping overground, trainers will be there to assist you if you need it. 
iii.
The testing will last from 2 to 4 hours.
e.
Reflexes
i.
A low level of electrical stimulation will be used over one of the nerves of your legs, back, 
neck or arms to measure how your leg muscles respond to the stimulation during standing 
and also during resting conditions.
ii.
A pad will be pasted over the skin of your leg, neck or back and a small current will pass 
through it.
iii.
For some tests you will hear a loud sound, it might take you by surprise and we will measure 
how your leg muscles respond to your reaction to the sound.
iv.
For some tests, we will magnetically stimulate your brain and we will measure how your leg 
muscles respond to the stimulation of your brain.
v.
You will be provided earplugs during the magnetic stimulation test. You will be asked to 
inform the technician if an earplug loosens or becomes detached and the test will be 
stopped immediately to minimize the risk of permanent hearing loss.
vi.
We may use stimulation of your brain, neck or arms in combination with epidural stimulation 
and measure the responses on your legs.
vii.
Each test will take approximately 2-3 hours to perform.
f.
Bladder Function
i.
You will be asked to rest on an exam table on your back.
ii.
A small tube will be inserted in your bladder. Your bladder will then be filled with water. The 
doctor or technician will measure the pressure in your bladder.
iii.
We may measure how your leg muscles respond to your bladder being filled and emptied. 
iv.
We may repeat this test with stimulation following your surgery.
v.
This test will last approximately 30 minutes.
g.
Cardiovascular Function
i.
We will measure your blood pressure, heart rate and breathing rate while you are lying down 
and also when you are moved to a seated position.
ii.
You will be asked to follow a diet excluding caffeine, alcohol, smoking, and foods that are 
high in fat on the evening prior to and the morning of study.
iii.
Devices will be pasted to your skin to record heart rate activity.
iv.
We will take a small blood sample (approximately 4 tablespoons) from your arm
v.
We may repeat this test with stimulation following your surgery and measure how your leg 
muscles respond to stimulation during this test.
vi.
This test will take approximately ninety (90) minutes to perform.
h.
We will ask you to fill short questionnaire(s)

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 4 of 13
Version: 09/13/17 
i.
We will ask you questions about your injury and its impact of your everyday life, autonomic 
function and sexual function.
ii.
You can refuse to answer any or all questions.
i.
Blood tests
i.
You will be asked to have a 12-hour fast the night before, including no food or drink (no 
alcohol or caffeine; water is allowed).
ii.
A blood sample will be drawn to look at chemicals that provide information about your bone 
formation, bone loss, inflammatory status, blood glucose control and overall metabolism. 
Approximately 4 tablespoons of blood is needed.
iii.
A sample of your blood may be stored for testing at the end of the study.
iv.
All specimens obtained during this study that are not processed immediately will be stored in 
the Medical Dental Research Building at the University of Louisville. Samples will be stored 
for future analysis related to this study. Your samples will be stored until all data related to 
this study has been analyzed and at the end of this period your specimen(s) will be 
destroyed.
v.
This testing will take approximately 15 minutes.
j.
Random Comprehensive Drug Screen
i.
You will be asked to provide a urine sample for random drug screening.
ii.
You may be asked to do this multiple times throughout your study participation. 
iii.
Your results from this test may cause you to be withdrawn from the study.
Yes, you may keep my blood and urine samples: 
 
Signature of Subject
Date signed
NO, you may not keep my blood and urine samples:  
 
Signature of Subject
Date signed
2.
Surgery
a.
You will be asked to complete several laboratory tests approximately 4 weeks before surgery. 
These tests are to assess and reduce your risk of infection. These may include nasal and rectal 
swabs, urine samples and blood samples. The study physicians may recommend treatment based 
on the results of these tests. You may be asked to repeat these tests.
b.
You will undergo spine surgery at University Hospital by Dr. Boakye or Dr. Neimat. You will also be 
asked to sign an additional surgical consent form required by University Hospital. This requires an 
operation on your lower back performed under sedation by intravenous medications injected into 
your body.
c.
A 4 to 6” cut will be made in your lower back and one electrode (device to produce electrical 
stimulation) measuring approximately ½ x 3” will be inserted in your spinal canal.
d.
During this 4-5 hour operation several electrical stimulations will be given to your spinal cord in 
order to determine the best place for the sensor.
e.
One 3” x 1/2” battery (generator) will be put under your skin through a cut placed in the lower 
abdomen (on each side). The subject and investigator will be able to adjust the electrical stimulator 
by an external device.
f.
Approximately half a cup of blood will be used during this operation, either from the surgical cuts or 
by the anesthesiologists who will draw blood to perform routine laboratory tests.
g.
The electrode and battery generator system will remain in place, but can be removed at your 
request. 

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 5 of 13
Version: 09/13/17 
h.
You will be monitored following your operation in the recovery room at University Hospital for 
approximately 4-24 hours and then may be transferred to the Frazier Rehab Institute.
i.
A second surgery will only be necessary in the rare case that the electrode wires become 
disconnected from the stimulator or the need to remove the electrode.
3.
Mid-experiments
a.
You may remain at the Frazier Rehab Institute for approximately 2 weeks (only if necessary) and 
will undergo the same experiments you did before your surgery.
b.
During some of these experiments we will use the sensors we placed in your back and send a 
stimulus to your spinal cord. We will find the best stimulation settings to help you move your legs, 
stand and walk.
4.
Locomotor Training
a.
The locomotor training program will take place approximately two weeks after your surgery.
b.
Each locomotor step/stand training session will last about 1-2 hours and will occur up to 5 times 
weekly for a total of 80 sessions each.  After the initial 20 sessions, we may ask you to come train 
in the lab twice a day. A session will be counted if the progression criteria have been met. We will 
use different stimulation patterns to assist you stand or step.
c.
You will be helped to step on a treadmill while wearing a harness that is attached to an overhead 
suspension device that will support the weight of your body.  There will be one person behind you 
and at your hips to help keep you stable. There will also be one person at each of your legs to 
assist you by helping you to put weight on your legs and to swing your legs.
d.
You will be helped to stand overground in a specially designed standing frame. There will be one 
person behind you and at your hips to help keep you stable. You will also be assisted to keep your 
knees extended and maintain good posture during standing.
e.
If you feel tired or need a break during the session you can take a break at any time.
f.
In the 80 sessions, the goal will be to reach your maximum comfortable walking speed on the 
treadmill with no assistance from the overhead suspension device that will support the weight of 
your body. We might train you to walk in the overground environment once you only need minimal 
assistance from the overhead suspension device.
g.
Throughout your 80 training sessions, we may repeat the experiments described above once a 
week.
h.
You might be asked to take a “Patient Programmer” device home, to practice additional standing 
with stimulation in a standing frame at home.
i.
We will only allow you to use the “Patient Programmer” at home if you have shown that you can 
perform leg movements in the supine position or stand independently in a standing device.
j.
The “Patient Programmer” will allow you to turn the stimulation on and off and up and down within 
the limits decided by the research team.
k.
If you are asked to do additional stand training at home you will be asked to keep a log of these 
sessions and bring it to the research team once a week.
l.
We might ask you to return to the laboratory for extended training (additional 80 - 200 sessions) 
during your follow up period. The training will be performed to optimize stand/step after a period of 
home training.

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 6 of 13
Version: 09/13/17 
Potential Risks
This study may involve risks that are currently unforeseeable. The study may involve the following physical 
risks and/or discomforts:
Surgical Risks 

Mild Discomfort (likely)

Bleeding (likely)

Bruising (likely)

Infection at the incision site 
(less likely)

Complications from 
anesthesia

Heart attack (rare)

Pneumonia (rare)

Blindness (rare)

Excessive blood loss (rare)

Death (rare)

There may be mild 
discomfort during the two 
operations which will be 
treated with pain 
medications as required.

If you have any of these 
difficulties from the 
surgeries, Dr. Castillo will 
be contacted immediately.
Psychological Risks 

It is unknown if there are 
psychological risk.

There is a possibility of a 
psychological risk if the 
procedure does not work 
but they are unknown.
Electrode/Device Risks

Jolting or shocking

Erosion

Undesirable change in 
stimulation

Allergic response

Hardware malfunctions or 
migration

Breakage or failure resulting 
in further injury to the spinal 
cord
Locomotor Training Risks

Dizziness with standing or 
stepping (likely)

Skin irritation from the 
harness or hand 
placements of the trainers 
helping your legs (likely)

Blood Pressure Changes 
(less likely)

Shortness of Breath (less 
likely)

Muscles & Joint Aches 
(rare)

Joint Sprain (rare)

Broken Bone (rare)

If you have any of these 
difficulties during standing
and stepping, we will stop 
the training session and Dr. 
Castillo will immediately be 
informed
Experiment Risks

Muscle soreness (likely)

Skin irritation from the 
sensors and/or wires (likely)

Tingling feeling over the 
legs or back from the 
stimulation (likely)

Changes in blood pressure 
and heart rate (likely)

Dizziness (likely)

Shortness of breath (less 
likely)

Bleeding at site of needle 
insertion (rare)

Burning or pressure when 
you urinate following the 
bladder test. (likely)

Bleeding when you urinate 
following the bladder test 
(rare).

Seizures from the magnetic 
brain stimulation (rare)

Temporary or permanent 
hearing loss from magnetic 
brain stimulation (rare)
You will be excluded from any testing using magnetic brain stimulation if you have any of the following:
•
metal in head, except mouth (i.e. cochlear implant, implanted brain stimulators, aneurysm clips)
•
increased intracranial pressure
•
cardiac pacemakers
•
implanted medication pump
•
intracardiac lines
•
significant heart disease
•
history of stroke or other brain lesions
•
personal or family history of epilepsy
•
you are receiving tricyclic antidepressants or neuroleptics
•
have had heavy alcohol consumption less than 48 hours prior to the test.

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 7 of 13
Version: 09/13/17 
Possible Pregnancy Risks
Pregnant women are excluded from this study, as the risk to the fetus is unknown. You should discuss 
pregnancy risks with your doctor before signing this consent form. Talk to your doctor about the best method of 
birth control to use while you are in this study. If you are pregnant or become pregnant, your unborn child may 
suffer harms that we have not seen before. It is important that you tell someone on the research team at 502-
581-8675 right away if you become pregnant during the course of this study. If you become pregnant, you will 
be terminated from the study by the study doctor.  If you become pregnant while in the study, the sponsor may 
ask to follow the outcome of the pregnancy. If you agree to allow the study doctor to follow your pregnancy, 
you will be asked to sign a separate consent form.
Benefits
We do not know the benefits of this study. Although there are no guarantees of benefits occurring during this 
experimental study, the information obtained from your participation in this study may help you and/or other 
patients who have/or will sustain spinal cord injuries in the future. 
Alternatives
Instead of taking part in this study, you could choose to not participate. There are no alternatives to this study.  
Research Related Injury 
If you are injured by being in this research study, the study doctor will arrange for you to get medical treatment. 
Your study doctor has not set aside money to pay for treatment of any injury.  You and your insurance will be 
billed for the treatment of these injuries.  Before you agree to take part in this research study you should find 
out whether your insurance will cover an injury in this kind of research. You should talk to the study doctor or 
staff about this. If you are injured, there is no money set aside for lost wages, discomfort, disability, etc.  You 
do not give up your legal rights by signing this form.  If you think you have a research related injury, please call 
your study doctor, Camilo Castillo, M.D. at 502-899-3623.
Payment
You will not be paid for your time or inconvenience while you are in this study.    
You will be paid by prepaid card for travel based on the federal mileage rate and parking fees up to $75 dollars 
per day while you are in the study.  Because you will be paid to be in this study, the University of Louisville may 
collect your name, address, social security number, and keep records of how much you are paid.  You may or 
may not be sent a Form 1099 by the University.  This will only happen if you are paid $600 or more in one year 
by the University. This will not include payments you may receive as reimbursement for actual expenses based 
on receipts or actual miles traveled.  We are required by the Internal Revenue Service to collect this 
information and you may need to report the payment as income on your taxes.  
You can still be in the study even if you don’t want to be paid.
Costs
There will be no additional costs to you for participating. However, you or your insurance company will be billed 
for all office visits and procedures that are part of routine medical care.  It is your responsibility to find out what 
costs, if any, your insurance company will cover before taking part in the study.   The cost of the operation(s) 

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 8 of 13
Version: 09/13/17 
that  will  take  place  at  University  Hospital  will  be  covered  by  that  institution.  The  cost  of  14  days  of 
hospitalization  at  Frazier  Rehab  Institute  (if  needed)  will  be  covered  by  that  institution.  Radiology  and 
anesthesia professional expenses will be covered by the radiology and anesthesiology PSCs at University 
Hospital. The epidural electrodes, leads, generator packs, and other expenses associated with the equipment 
for the operations will be also coved by the research project. Postoperative care provided by Drs. Boakye, 
Neimat and Castillo related to this study will be provided without charge for the duration of your participation in 
the study.  Should any further procedures be required related to the epidural leads, and/or battery generator, 
the expenses incurred for those procedures will be covered by the participating institutions.  If you are injured 
by the research, there may be additional cost to you for participating.  Otherwise there will be no additional cost 
to you.
HIPAA Research Authorization 
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides federal safeguards for your 
protected health information (PHI).   Examples of PHI are your name, address, and birth date together with 
your health information.  PHI may also include your medical history, results of health exams and lab tests, 
drugs taken and results of this research study.  Your PHI may not be used or shared without your agreement, 
unless it meets one of the HIPAA exceptions. 
State and federal privacy laws protect your health information.  In most cases, health information that identifies 
you can be used or shared by the research team only if you give your permission by signing this form.   
If you sign this form your health information will be used and shared to answer the research questions 
described in this document and to make sure that the research was done correctly. The time period when 
information can be used or shared ends when all activities related to this study are completed.  
Your access to your health information will not be limited during this study. When the study is over, you will 
have the right to see your health information related to this research.
You do not have to sign this form.  If you do not sign this form you may not participate in the study and health 
information that identifies you will not be shared with the research team.  
Site(s) where health information about you will be used or shared for this research:
In our research, the research team will look at and may share information about you and your health.  Federal 
law requires that health care providers and researchers protect the privacy and security of health information 
that identifies you.  We may ask for your health information from the following:
Affiliated Sites: 
University of Louisville
University of Louisville Hospital
Frazier Rehab Institute
Unaffiliated Sites: Any physician offices, clinics or medical facilities where you may seek treatment during this 
study.
Protected health information (PHI) that will be used or shared for research 
Diaries and questionnaires
Records of your operation(s) 
Discharge summaries
Medical Progress notes

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 9 of 13
Version: 09/13/17 
Healthcare provider orders
Photos, videotapes or digital or other image
History and physical exams                                      
Records about the study device
Laboratory, x-ray and other tests
Revocation of Research Authorization
You may cancel the permission you have given to use and share your protected health information at any time.  
This means you can tell us to stop using and sharing your protected health information.  If you cancel your 
permission:

We will stop collecting information about you.

You may not withdraw information that we had before you told us to stop.
o
We may already have used it or shared it.
o
We may need it to complete the research.

Staff may ask your permission to follow-up with you if there is a medical reason to do so.
To cancel your permission, you will be requested to complete a written “Revocation of Research Authorization” 
form located at the end of this document.  You may also obtain a copy from your study doctor, designated 
personnel or from the Human Subjects Protections Program Office website 
(https://louisville.edu/research/humansubjects/templates/biomedical-forms). 
Information Available on ClinicalTrials.gov
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  
This website will not include information that can identify you. At most, the website will include a summary of 
the results. You can search this website at any time.
Confidentiality
Total privacy cannot be guaranteed.  We will protect your privacy to the extent permitted by law.  If the results 
from this study are published, your name will not be made public. Once your information leaves our institution, 
we cannot promise that others will keep it private.  
Your information may be shared with the following:

The sponsor, The Leona M. and Harry B. Helmsley Charitable Trust and others hired by the sponsor to 
oversee the research

Organizations that provide funding at any time for the conduct of the research.

The University of Louisville Institutional Review Board, Human Subjects Protection Program Office, 
Privacy Office, others involved in research administration and compliance at the University, and others 
contracted by the University for ensuring human subjects safety or research compliance

The University of California Los Angeles Institutional Review Board, Office for Protection of Research 
Subjects and others involved in the research program at the University.

The local research team

Researchers at other sites participating in the study 

People who are responsible for research, compliance and HIPAA oversight at the institutions where the 
research is conducted, i.e. Frazier Rehab Institute and University Hospital

Government agencies, such as: 
o
Office for Human Research Protections 

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 10 of 13
Version: 09/13/17 
o
Office of Civil Rights
o
Food and Drug Administration 

People responsible for billing, sending and receiving payments related to your participation in the study 

Data Safety Monitoring Board

Medtronic
Medtronic will keep your health information confidential in accordance with all applicable laws and 
regulations. Medtronic may use your health information for its business purposes, such as overseeing and 
improving the performance of its device, new medical research and proposals for developing new medical 
products or procedures, and another business purposes. Any reports or publications about the study or any 
other research will not include your name or a description of you. Information received during the study will 
not be used to market to you; your name will not be placed on any mailing lists or sold to anyone for 
marketing purposes.
Security 
Your data will be kept private by being stored in a locked cabinet behind closed door with limited access. 
Electronic data is stored on a password protected computer with limited access in a locked area.
 
Conflict of Interest 
This research study utilizes a device that is licensed to Power NeuroRecovery. The person running this study 
(or member of this research team) has a relationship with Power NeuroRecovery. If you have any questions 
about this conflict of interest, please talk to Holly Symonds Clark at (502) 852-3853. She is a not a member of 
the study team and does not have a conflict of interest related to the study.
Voluntary Participation
Taking part in this study is completely voluntary. You may choose not to take part at all.  If you decide not to be 
in this study, you won’t be penalized or lose any benefits for which you qualify. If you decide to be in this study, 
you may change your mind and stop taking part at any time. If you decide to stop taking part, you won’t be 
penalized or lose any benefits for which you qualify. If you would like the electrodes removed from your body 
they will be removed.   If you decide to withdraw from the study and have the electrodes removed please 
contact Dr. Harkema at (502) 581-8675. You will be asked to meet with Drs. Harkema, and Boakye and/or 
Neimat determine an appropriate surgery date for the removal of the electrodes.
You will be told about any new information about the study that could affect your decision to continue in the 
study.
Termination
Your study doctor has the right to stop this study at any point. Your study doctor may take you out of this study 
with or without your okay.  Reasons why this may occur include circumstances that arise which warrant doing 
so.  The decision may be made either to protect your health and safety, or because it is part of the research 
plan that people who develop certain conditions may not continue to participate.  If the study doctor believes 
that the pain or discomfort might pose a risk to you, you will be terminated from the study.     If you become 
pregnant you will be terminated from this study.

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 11 of 13
Version: 09/13/17 
Participation in Other Research Studies
You may not take part in this study if you are currently in another research study.  It is important to let your 
doctor know if you are in another research study.
Contact Persons
If you have any questions, concerns, or complaints about the research study, please contact Susan Harkema, 
Ph.D. at (502) 581-8675.
Once you are enrolled in this study, you will be given additional contact numbers that are answered 24/7 to 
reach a designated research staff member if you need immediate assistance.
Research Subject’s Rights
If you have any questions about your rights as a research subject, you may call the Human Subjects Protection 
Program Office at (502) 852-5188.  You may discuss any questions about your rights as a research subject, in 
private, with a member of the Institutional Review Board (IRB).  You may also call this number if you have 
other questions about the research, and you cannot reach the study doctor, or want to talk to someone else. 
The IRB is an independent committee made up of people from the University community, staff of the 
institutions, as well as people from the community not connected with these institutions.  The IRB has 
approved the participation of human subjects in this research study.
Concerns and Complaints
If you have concerns or complaints about the research or research staff and you do not wish to give your 
name, you may call the toll free number 1-877-852-1167.  This is a 24 hour hot line answered by people who 
do not work at the University of Louisville.  

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 12 of 13
Version: 09/13/17 
Acknowledgment and Signatures
This informed consent document is not a contract.  This document tells you what will happen during 
the study if you choose to take part.  Your signature indicates that this study has been explained to 
you, that your questions have been answered, and that you agree to take part in the study.  You are 
not giving up any legal rights to which you are entitled by signing this informed consent document.  
You will be given a copy of this consent form to keep for your records. 
_______________________________________
__________________________________________
Subject Name (Please Print)
Signature of Subject
   Date Signed
______________________________
_____________________________________________
Printed Name of Legally 
Signature of Legally 
Date Signed
Authorized Representative (if applicable) 
Authorized Representative
    
______________________________________
Authority of Legally Authorized Representative to act on behalf of Subject
*Authority to act on behalf of another includes, but is not limited to parent, guardian, or durable power of attorney for 
health care.
_________________________________________
______________________________________________
Printed Name of PersonExplaining Consent Form
Signature of Person Explaining 
Date Signed
Consent Form (if other than the Investigator)
 
___________________________________________
______________________________________________
Printed Name of Investigator
Signature of Investigator
Date Signed
______________________________________________________________________________________________
List of Investigators:
Phone Numbers:
Susan Harkema, Ph.D.
(502) 581-8675
Maxwell Boakye, M.D.
(502) 540-3694
Camilo Castillo, M.D.
(502) 333-8155
Claudia Angeli, Ph.D.
(502) 581-8675
Joseph Neimat, M.D.
(502) 581-8675

UofL Institutional Review Boards
IRB NUMBER: 07.0066
IRB APPROVAL DATE: 04/19/2018
IRB EXPIRATION DATE: 10/18/2018
STUDY TITLE: SPINAL EPIDURAL ELECTRODE ARRAY TO FACILITATE STANDING AND STEPPING IN SPINAL CORD INJURY
Page 13 of 13
Version: 09/13/17 
REVOCATION OF AUTHORIZATION FOR USE AND DISCLOSURE OF YOUR HEALTH 
INFORMATION FOR RESEARCH
Return To:
PI Address: 
220 Abraham Flexner Way 
 
Louisville, KY 40202
PI Phone:    
502-581-8675 
□ Main
□ Blood Sample
□ Urine Sample
To Whom It May Concern:
I would like to discontinue my participation in the research study noted above. I understand that health information already 
collected will continue to be used as discussed in the Authorization I signed when joining the study.
Your options are (choose one):
□
Withdraw from Study & Discontinue Authorization:
Discontinue my authorization for the future use and disclosure of protected health information. In some instances, the 
research team may need to use your information even after you discontinue your authorization, for example, to notify 
you or government agencies of any health or safety concerns that were identified as part of your study participation. 
□
Withdraw from Study, but Continue Authorization:
Allow the research team to continue collecting information from me and my personal health information. This would be 
done only as needed to support the goals of the study and would not be used for purposes other than those already 
described in the research authorization.
_________________________________________________________
___________________
Printed Name and Signature of Subject
Date Signed
_________________________________________________________
___________________
Signature of Subject’s Legal Representative (if subject is unable to sign)
Date Signed
_________________________________________________________
___________________
Printed Name of Subject’s Legal Representative 
Birthdate of Subject
_________________________________________________
Relationship of Legal Representative to Subject
_________________________________________________________
___________________
Subject’s Address
Subject’s Phone Number
Optional:
I am ending my participation in this study because: __________________________________________________
Institutional Review Board
MedCenter One, Suite 200
501 E. Broadway
Louisville, KY 40202
OR
Do not sign this letter unless you are withdrawing from this research.   You will be 
sent confirmation that this notice was received.