UNIVERSITY OF LOUISVILLE
INSTITUTIONAL REVIEW BOARD
Date Approved 04/22/2013 Valid Thru 4/18/2014

SUBJECT INFORMED CONSENT DOCUMENT
BACLOFEN WITH LOCOMOTOR TRAINING: THE EFFECT ON FUNCTION AND NEUROPLASTICITY
IN CHRONIC INCOMPLETE SPINAL CORD INJURY
Sponsor assigned number:

H133N110007

Sponsor(s) name & address:

National Institute on Disability and Rehabilitation Research
U.S. Department of Education
400 Maryland Avenue, S.W., Mailstop PCP-6038
Washington, DC 20202

IRB assigned number:

12.0151

Investigator(s) name & address:

Susan Harkema, PhD
Frazier Rehab Institute
220 Abraham Flexner Way, Ste. 1506
Louisville, KY 40202

Site(s) where study is to be
conducted:

Phone number(s) for subjects to
call for questions:

University of Louisville Hospital
Frazier Rehab Institute

(502) 581-8675 or (502) 540-3694

Introduction and Background Information
You are invited to take part in a research study because you have sustained a chronic, non-progressive
spinal cord injury and suffer from spasticity. The study is being conducted under the direction of Susan J.
Harkema, PhD, Andrea Behrman, PhD, PT, Steve Williams, MD, Alexander Ovechkin, MD, PhD, and Daniel
E. Graves, Ph.D. FACRM. Ninety (90) local individuals will be invited to participate. The study is sponsored
by the U.S. Department of Education, National Institute on Disability and Rehabilitation Research and the
University of Louisville, Department of Neurological Surgery and will take place at the Frazier Rehab
Institute in Louisville. Your participation in this study will last for 4 months.
If you are pregnant, anticipate pregnancy or are nursing you are not eligible to participate in this study.
This consent form explains why this research study is being done and what your role will be if you decide to
be in this study. This form also describes the possible risks connected with being in this study. Research
studies only include people who want to take part. Before you decide to take part, please take as much
time as you need to ask any questions and discuss this study with the study doctor or staff, or with family,
friends or your personal physician or other health professionals.
To be in a research study you must give your informed consent. “Informed consent” includes:

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



Reading this consent form,
Having the study doctor or staff explain the research study to you,
Asking questions about anything that is not clear.

You should not join this research study until all of your questions are answered. If you take part in this
research study, you will be given a copy of this consent form. Being a part of the study is entirely up to you
and you can refuse without any of your healthcare being affected.
If you choose to participate in this research study, you will be randomly assigned to receive either locomotor
training (LT) alone or locomotor training with baclofen (LTB). “Randomly assigned” means that the
treatment you receive will be decided by chance (like flipping a coin). You will have an equal chance of
receiving either LT or LTB.

Purpose
The purpose of this study is to find out how baclofen with locomotor training or locomotor training alone
affects your walking, nervous system spasticity and coordination changes, neuromuscular activation during
voluntary movements and stepping, heart and kidney function and your quality of life.
Procedures
If you decide to be in this study, you will be randomized, similar to “flipping a coin” into one of two treatment
groups. One group will receive locomotor training alone and the other group will receive locomotor training
and oral baclofen.
The following tests or procedures will be performed during the 4-month period that you will be expected to
participate in the study. The expected time to complete each test is listed below beside the heading of each
test. All tests may not be performed.
1. Physical Exams (1-1.5 hours)
You will undergo a physical exam at each study visit which includes checking vital signs, edema
assessment, adverse event assessment, other medications you may be taking, other treatments you may
be receiving, compliance with the study medication and dispensing medications.
2. Laboratory Evaluations (Blood tests) (10-20 minutes)
After 2 months of being in the study, we will collect up to 20mL of blood or just a little over 4 teaspoons of
blood to evaluate baclofen levels in your body and to conduct a blood chemistry and hematology test.
These tests will also help to assess your health and how your organs, including your liver and kidneys are
working. The blood will be collected by venipuncture (placing a small needle in your arm to withdraw blood
from your vein). Your blood will not be used for any other purpose.
3. 6-minute Walk Test (15-20 minutes)
During the 6-minute walk test, you will be asked to walk as far as you can for 6 minutes. You may use a
walking aid if you need one. The person doing the test (technician) will tell you what devices you can use.
You may want to avoid having a conversation so that you can save your breath for walking. You may also
stop and rest as many times as needed. A staff member will always be walking by your side to assist you if
needed.

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4. Modified Ashworth Scale (5-10 minutes)
This is a test that measures the amount of muscle contractions in your arms and legs that you are unable to
control. You will be asked to lie flat on your back while the person doing the test (technician) moves your
arms and legs to find out how much muscle tone and flexibility you have in your legs and arms.
5. Pulmonary Function Test (spirometry) (30–40 minutes)
This is a test that measures how much air your lung is able to move in and out of your lungs and how much
of airway pressure your muscles can create. We will be using standard equipment while you are sitting in
your personal wheelchair. The technician will ask you to sit and then place a soft clip over your nose. You
will be asked to take a full, deep breath and then blow it out as quickly and completely as possible into a
mouthpiece that is connected to a machine called a spirometer. You will be asked to repeat this process
three (3) times.
6. Quality of Life (QOL) (30-60 minutes)
You will be asked to complete several questionnaires about your quality of life or how you are doing.
a. The SCI-QOL/SCI-CAT
This questionnaire will be used to measure the quality of your life as it relates to your physical
abilities, medical health, emotional and socialization.
b. SF-36
This questionnaire will be used to measure the outcome of your medical care including any
physical limitations, bodily pain, your ability to function and your emotional and mental health.
c. Satisfaction with Life Scale (SWLS)
This test was developed to assess how satisfied you are with your life and to measure changes
in the level of your satisfaction over time.
7. Functional Neurophysiological Assessments (FNPA)
FNPA is used to show how your neurological system is able to control your movement, balance.- You will
be asked to do several different movements while you are lying on your back, sitting, or standing. EMG
electrodes will be placed on your skin to record the electrical activity of your muscles during these
movements. Muscles recorded will be in your arms, trunk, legs, neck, or a combination. Lower limb reflexes
will also be performed.
8. Respiratory motor control assessment (RMCA) (3-3.5 hours)
We will ask you to repeat the pulmonary function test when you are sitting in a special chair and lying on
your back while we are recording the electrical impulses from your neck, chest, arms, legs, abdomen and
back by placing adhesive sensors over the muscles and heart. We will also record how your chest and
abdomen are moving by placing elastic belts around your chest and abdomen. We will also record your
blood pressure using a finger cuff. This test will last about three hours.
9. Orthostatic Stress Test (1.5 hours)
This test will be measuring your blood pressure, heart rate and your chest and abdomen movements while
lying down on your back and when the position is suddenly changed to sitting. During this test, licensed
personnel will take blood samples (approximately 4 tablespoons) from a small catheter inserted in the vein
in your arm. This test will last about two hours.

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10. Cardiac Ultrasound (1 hour)
The cardiac ultrasound exam will be conducted by the Jewish Hospital Cardiopulmonary Diagnostics team.
This standard procedure will measure cardiac output. There will be a physical therapist present to assist
with transfers and other volunteer needs. Three ECG electrodes will be placed on your chest and
ultrasound gel will be used with a Doppler device on the front and side of your chest for proper viewing of
the heart. You will be lying down on your side during the test, which takes approximately 15-20 minutes.
The exam technicians will only be looking for information relevant to the cardiac output measurement. The
purpose of the exam is not to assess overall cardiovascular health or to diagnose unknown diseases.
However, if abnormalities are inadvertently observed that may put your health at risk, we will report these
findings to our study physician. In addition, the Jewish Hospital Cardiopulmonary Diagnostics and Frazier
Rehab Research Team(s) will not be held liable for undiscovered cardiovascular health issues present at
the time of the exam.
Baclofen Administration and Weaning:
If you are randomized to the LT with baclofen study group, and are currently taking baclofen you will
continue using your medication as prescribed by your doctor. However, the study doctor (Dr. Williams) may
modify your medication depending on the results of the screening tests.
If you are randomized to the LT without baclofen group and you are taking baclofen, you will be weaned off
by having your dose gradually reduced to where you are no longer taking baclofen.
If you are taking multiple medications including baclofen, you will be gradually weaned off baclofen. You will
be asked to remain on the same dose of the other medications while you are in the study.
If you cannot be weaned off baclofen because it will affect your ability to carry out your daily activities, your
dose will be reduced to the lowest level you need to function.
If you are randomized to the LT with baclofen study group and are not taking baclofen, you will be given
baclofen. Your dose will be individualized and Dr. Williams will determine the right dose that does not
interfere with your ability to function.
Potential Risks
Participation in this study may involve the following risks and/or discomforts:
a. Risks from Physical Exam
There are virtually no risks associated with a physical examination and complications with the
process of a physical examination are unusual.
b. Risks from Blood Draws:
Though venipuncture is routinely done and relatively safe, the following list includes potential risks
that can occur from blood draws:
 Feeling of light-headedness (likely: more than 40%)
 Bruising (likely: more than 40%)
 Pain (less likely: 1-39%)
 Infection (rare: less than 1%)
c. Risks from neurophysiological tests and procedures (Locomotor Training, 6-minute Walk Test,
Modified Ashworth Scale, ASIA , RMCA Spirometry, Orthostatic Stress Test, and FNPA)
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Likely (more than 39%)



skin irritation from
electrodes or hand
placement of the trainers
tingling feeling from the
stimulation

Less Likely (1-39%)




big changes in blood
pressure
shortness of breath
headache or neck ache

Rare (less than 1%)







jaw muscle contractions
resulting in biting of tongue
seizure
nausea
fatigue
muscle soreness
broken bones or strain
during sitting or standing
tests

d. Risks from taking baclofen
Most Common
Transient or brief drowsiness
Dizziness
Weakness
Fatigue

Less Common
10 to 63%
5 to 15%
5 to 15%
2 to 4%

Confusion
Nausea
Headache
Insomnia
Hypotension
Constipation
Urinary frequency

1 to 11%
4 to 12%
4 to 8%
2 to 7%
0 to 9%
2 to 6%
2 to 6%

Baclofen Risks Continued:
Cardiovascular:
 difficulty breathing
 fast/irregular heart
beat
 chest pain
 fainting

Rare (less than 5%)
Genital/Urinary:
Gastrointestinal:
 involuntary
 dry mouth
discharge of urine
 loss of appetite
 urinary retention
 taste disorder
 difficulty urinating
 abdominal pain
 impotence
 vomiting
 inability to ejaculate
 diarrhea
 excessive urination
 positive test for
at night
occult blood in stool
 blood in urine

Laboratory tests:
 increased liver
enzymes
 increased blood
sugar levels

There are no foreseeable psychological, social, economic, and/or legal risks. However, you may suffer
harms that we have not seen before. If the risks of neurophysiological tests and procedures and the side
effects from taking baclofen become unpleasant, you can stop the study at any time. Also, if you are
uncomfortable answering questions from any of the Quality of Life questionnaires, you are free to decline
answering the uncomfortable questions.
Possible Pregnancy Risks
Pregnant women are excluded from this study as the risk to the fetus is unknown. You should discuss study
risks with your doctor before signing this consent form. If you are pregnant or become pregnant, your
unborn child may suffer harms that we have not seen before. If you are a female who is able to have
children, you will be required to perform a urine pregnancy test two (2) months after you are in the study. It
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is important that you tell Steve Williams, MD or Susan Harkema, PhD at (502) 581-8675 right away if you
become pregnant during the course of this study. There is a risk that your unborn baby could be harmed if
you become pregnant during your participation in the study. 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. If you become pregnant, you will be
terminated from this portion of the study.
Benefits
The information collected may or may not benefit you directly; however, the information learned in this study
may be helpful to others. The information collected will give the researchers a better understanding of how
baclofen and locomotor training affect walking, neuromuscular activation during voluntary movements and
the quality of life for individuals with spinal cord injuries.
Alternatives
Your participation in this study is entirely voluntary. You are free to refuse to be in the study and your
refusal will not affect any treatment you are receiving at the Frazier Rehab Institute.
Research Related Injury
If you are injured as a direct result of participating in this research study, the study doctor will arrange for
you to get medical treatment. The study site or your study doctor has not set aside money to pay for
treatment of any injury. Some insurance companies will not pay for treatment costs for people who
participate in a research study. 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 possibility. 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 Susan Harkema PhD or Daniel E. Graves, Ph.D.
FACRM or Andrea Behrman, PhD, PT at (502) 581-8675, or Steve Williams, MD, at 502-333-8155
Compensation
You will be compensated for your travel to and from Frazier Rehab Institute for your participation in this
study to participate in any tests that are not associated with your usual care based on the federal standard
mileage rate up to $30.00 per day. Because you will be paid to be in this study the University of Louisville
must collect your name, address, social security number, ask you to sign a W-9 form, 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. 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.
This information will be protected and kept secure in the same way that we protect your other private
information. If you do not agree to give us this information, we can’t pay you for being in this study. You
can still be in the study even if you don’t want to be paid.
Costs
If you are injured by the research, there may be additional cost for participating in the research. 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. Some insurance companies will not pay for treatment costs for people who participate in a

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research study. You may call your insurance company to find out what they will and will not pay for before
participating in this research study. Otherwise there will be no additional cost to you.
The study drug used in this study will be provided at no cost to you.
HIPAA Research Authorization
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides federal safeguards for
protected health information (PHI). Examples of PHI are your name, address, and birth date. 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. If you agree to take part in this research you may be required to sign a "Research
Authorization" form. This allows the use and sharing of your PHI by those listed in the “Research
Authorization.”
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. A description of this clinical trial
will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include
information that can identify you. At most, the Web site will include a summary of the results. You can
search this Web site at any time.
The following may look at your research and medical records:
 The University of Louisville Institutional Review Board, Human Subjects Protection Program Office,
Privacy Office and others involved in research administration at the University
 Others hired by the site to oversee the research
 Jewish Hospital & St. Mary’s Healthcare, Centers for Advanced Medicine
 Government agencies, such as:
o U.S. Department of Education
o National Institute on Disability and Rehabilitation Research
o Office for Human Research Protections,
o Office of Civil Rights,
o Food and Drug Administration
o Data Safety Monitoring Board(s) related to the study and
 People responsible for billing, sending and receiving payments related to your participation in the
study.
In most cases, the information released to the above listed individuals or entities will not contain your name,
social security number, or any other personal information. However, representatives authorized by Susan
Harkema PhD, IRB, FDA or other government agencies (U.S. Department of Education, National Institute
on Disability and Rehabilitation Research) may review records containing personal information to make sure
that the study information is correct. Because of the need to provide information to these parties, absolute
confidentiality cannot be guaranteed.
Security
The information gathered from this study will be stored in a database. Your name will not be linked to the
information because it will be stored using a coded identification number. The data will be entered into a
password protected computer on a secure server, with limited access to a locked room.

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Conflict of Interest
This study does not involve any conflicts of interest for the investigator or the institution.
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.
You will be told about any new information learned during 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: a) it is in your best interest to be
withdrawn from this study; b) you do not follow the study instructions and/or study schedule; c) you
experience an injury or illness or other side effects; or d) the study is terminated prematurely. 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. The sponsor of the study or the
Institutional Review Board can also stop the study at any time. If you become pregnant you will be
terminated from this study.
Participation in Other Research Studies
You may 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 Dr. Harkema
or any of the study investigators at (502) 581-8675. Once you are enrolled in this study, you will be given
additional contact numbers to reach the clinical research nurse, a designated research staff member or Dr.
Harkema directly 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 reviewed this research study.
If you are willing to participate in the study but you are unable to sign the consent due to arm or hand
impairment, a legally authorized representative (LAR) will be used to sign for you with your permission. If a
LAR signs the consent for you, and later during the course of the study you are able to sign, then you will be
re-consented.
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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.
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 by signing this informed consent document. You will be given a copy of this consent form to
keep for your records. If you are unable to sign this consent and, your legally authorized representative
signs for you to participate in the study, you will be asked to re-sign the consent when you are capable of
doing so and, if you are still enrolled in the research study.
Do you want your primary care physician notified that you are a subject in this study? _____Yes _____No

__________________________
Printed Name of Subject

__________________________
Printed Name of
Subject/Legal Representative

_________________________________ ____________
Signature of Subject/Legal Representative Date Signed

__________________________
_________________________________
Printed Name of Person
Signature of Person Explaining
Explaining Consent Form
Consent Form (if other than the Investigator)

____________
Date Signed

__________________________
Printed Name of Investigator

_____________
Date Signed

LIST OF INVESTIGATORS
Susan J. Harkema, PhD
Daniel E. Graves, Ph.D. FACRM
Steve Williams, MD
Andrea Behrman, PhD, PT
Alexander Ovechkin, MD, PhD

_________________________________
Signature of Investigator
PHONE NUMBERS
(502) 581-8675
(502) 582-7443
(502) 333-8155
(502) 581-8675
(502) 581-8675

UNIVERSITY OF LOUISVILLE
INSTITUTIONAL REVIEW BOARD
Date Approved 04/22/2013 Valid Thru 4/18/2014

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