Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis: An Observational Case-control Study
Conditions: Multiple Sclerosis
Sponsor: Colorado State University

 
NOTICE OF APPROVAL FOR HUMAN RESEARCH
DATE:
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Research Integrity & Compliance Review Office
Office of the Vice President for Research
321 General Services Building - Campus Delivery 2011 eprotocol
TEL: (970) 491-1553
FAX: (970) 491-2293
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Approval Period:
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IRB Number:
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Research Integrity & Compliance Review Office
Office of the Vice President for Research
321 General Services Building - Campus Delivery 2011 eprotocol
TEL: (970) 491-1553
FAX: (970) 491-2293
 

 
PROTOCOL
Biomedical
Colorado State
University
Protocol # 16-6685HH
 Date Printed: 07/18/2018
Continuing review
1
Personnel Information
3
Subject Population
4
Study Location
4
General Checklist
5
Funding
6
Expedited Paragraphs
7
Purpose,Study Procedures,Background
8
Radioisotopes or Radiation Machines
11
Medical Equipment for Human Subjects and Laboratory Animals; Investigatiional Devices
12
Drugs, Reagents, or Chemicals
12
Subject Population (a-g)
12
Subject Population (h-m)
13
Risks
15
Benefits, Procedures to Maintain Confidentiality
17
Potential Conflict of Interest
18
Informed Consent
19
Assent Background
19
HIPAA
20
Attachments
21

 
PROTOCOL
Biomedical
Colorado State
University
Protocol # 16-6685HH
 Date Printed: 07/18/2018
Obligations
24
Event History
24

Page 1 of 25
 
1
PROTOCOL
Biomedical
Colorado State
University
Protocol # 16-6685HH
 Date Printed: 07/18/2018
Protocol Title:
Medical marijuana and its effects on motor function in people with Multiple Sclerosis: An
observational case-control study.
Protocol Type:
Biomedical
Date Submitted:
06/06/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
* * * Continuing review * * *
 
To renew your protocol: 1. Complete this one-page form; 2.  If necessary, update any sections of the protocol
that need to be updated for the upcoming year (e.g., change in personnel, location); 3. Electronically "sign" the
application by clicking in the check box on the bottom of the "Obligations" page; 4.  Remember to click "Submit
Form" and confirm your intent to submit by clicking "OK" so that the IRB administrators receive your application.
You must answer each question. Input N/A to answer any questions that are not applicable.  NOTE:  Documents
that contain much of the information required to answer the participant number questions below can be found in
the "Event History" section of each protocol.  The status on your homepage will be "Submitted to IRB" when your
submission is successful. IMPORTANT:   If the Department Head has changed since your last approval, please
be sure to update the Department Head listing on the personnel Information screen of your protocol.
 
1.
Summary: Number of Participants Associated with the Protocol: 
 
  
  
 a. 
Total number of participants approved to date:
40 (20 MS users; 20 MS non users)
 
  
  
 b. 
Number of participants studied since the last approval date:
6 (all MS users)
 
  
  
 c. 
Total number of participants studied since the beginning of the project:
6
 
  
  
 d. 
Number of participants remaining to study (total number of participants approved  LESS  the
total number of participants studied to date):
34
(14 MS users; 20 MS non users)
 
  
  
 e. 
Please explain if there is a discrepancy in participant numbers (e.g., more participants
responded to a survey than had been approved):
N/A
 
 
2.
 a. 
Reasons and number of withdrawals from the research (both subject and investigator initiated)
since the last approval date.

Page 2 of 25
 
2 - participants never showed up for scheduled visits and never returned communications, no
procedures were performed on these participants
 
  
  
 b. 
Number of subjects lost to follow-up since the beginning of the study.
N/A
 
  
  
 c. 
Please summarize any protocol deviations/violations or unanticipated problems (UPs)/adverse
events (AEs) since the last continuing review or original approval (if this is your first continuing
review).  Please indicate if any of the unanticipated problems/events are being reported to the
IRB for the first time.  If you have or will make changes to your protocol as a result of any
unanticipated problem/event or adverse event, please summarize those changes in Question #5
below.
none
 
 
  
  
 e. 
Complaints about the research during the last year.
none
 
3.
A summary of any recent findings, literature, or other relevant information (especially pertaining to
risks), if applicable.
N/A
 
4.
Description of the remainder of project:
Y
Do you plan to recruit more subjects?
 
If "No," have all subjects completed all research-related interventions?  Note: Protocols must be
renewed to continue recruiting participants and/or collect data from already recruited participants.
 
N
Are you only performing data analysis?  NOTE:  If you are analyzing data with no identifiers (i.e., you
cannot link your data to individuals), you can close your protocol by submitting a Final Report.
 
N
Does this protocol have a Data Satety Monitoring Board (DSMB)?
 
If you do have a DSMB, have reports been submitted to the IRB and/or the Sponsor?
Upload any DSMB reports that have not yet been submitted to the IRB since the approval
or last continuing review.
 
5.
Summarize all approved changes in the protocol since the last continuing review or since the original
approval (if this is your first continuing review).  For example: Have you amended your protocol
during the past year?  Are you requesting to make any changes for the upcoming year?  Have you
included any changes as a result of an unanticipated problem/event or Adverse events (AE)?  Have
there been any personnel changes in the past year (including a change in department head)?
balance test changed - legged test to two legged test (mCTSIB)
No Rate of Force Development tests performed
Order tests in each visit changed
 
         
If necessary, proceed to the appropriate section(s) of the protocol and make your requested changes.
Remember that if you are requesting to revise a document that is already attached, you must delete the
already attached document and upload the revised document.
 

Page 3 of 25
 
6.  
List of Protocol Sections (and questions) that have been changed/modified.
N/A
---------------------------------------------------------------------------------------------
* * * Personnel Information * * *
IMPORTANT NOTE: Mandatory Personnel on a protocol are: Principal Investigator and Department Head. Only
the Principal Investigator can submit the protocol; although other personnel listed on the protocol can create the
protocol. Human Subjects Protection Training is mandatory for Principal Investigator, Co-Principal Investigator,
and Key Personnel (as defined by NIH). Training must be updated every three (3) years.
 
Principal Investigator  Mandatory
Name of Principal Investigator
(Faculty, Staff or Postdoc)
Degree
Title
Rudroff, Thorsten
Assistant Professor
Email
Phone
Fax
Thorsten.Rudroff@colostate.edu
(970) 491-8655
Department Name
Campus Delivery Code
 
Health and Exercise Science
 
 Human Subjects Training Completed? PIs must complete training every three
(3) years.
Y
 
CO-Principal Investigator
Name of Co-Principal Investigator
(This could be another faculty or a
Master's or Ph.D. student)
Degree
Title
Kindred, John
Graduate Assistant
Email
Phone
Fax
John.Kindred@colostate.edu
Department Name
Campus Delivery Code
 
Health and Exercise Science
 
 Human Subjects Training Completed? Training is required for Co-PI. Training
must be updated every three (3) years.
Y
No training data is available.
 
 
Department Head  Mandatory
Name of Department Head
Degree
Title
Braun, Barry
Professor
Email
Phone
Fax
Barry.Braun@colostate.edu
(970) 491-7875
Department Name
Campus Delivery Code
 
Health and Exercise Science
 
 Human Subjects Training Completed?? Training is not required for
Department Head. Select "No" if you do not know if your Department Head has
completed training or not.
Y
 
Administrative Contact

Page 4 of 25
 
Name of Administrative Contact,
Project Director, or Lab Coordinator
Degree:
Title
Biela, Laurie
Email
Phone
Fax
Laurie.Biela@colostate.edu
Department Name
Campus Delivery Code
 
244
 
 Human Subjects Training Completed? Training is not required for
Administrative Contacts
N
No training data is available.
 
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
 
 
Subject Population(s) Checklist
        Â Select All That Apply - Note that this is your Targeted Population :
X
 Adult Volunteers
 Decisionally Challenged
Elderly
 Employees
 Fetuses
X
 Long-Term Patients
 Mentally Disabled
 Minors (under 18)
 Pregnant Women
 Prisoners
 Soldiers
 Students
 Other (i.e., non-English Speaking or any population that is not specified above)
       
---------------------------------------------------------------------------------------------
* * * Study Location * * *
 
 
Study Location(s) Checklist
         Select All That Apply - NOTE: Check "Other" and input text: 1.) If your study location is not listed, or 2.) If
you would like to list details of your already-checked location (e.g., specific school within a school district)
Aims Community College
Colorado Department of Public Health & Environment
X
Colorado State University
Colorado State University - Pueblo Campus
Denver Public Schools
Greeley/Evans School District
Poudre School District
University of Colorado Health - North (Formerly -Poudre Valley Health System - PVHS)
Rocky Mountain National Park
Thompson School District

Page 5 of 25
 
University of Colorado - Boulder
University of Colorado - Colorado Springs
University of Colorado - Denver
University of Colorado Health Sciences Center
University of Northern Colorado
Other (In the box below, list your study location if not checked above. You may also list details of your
already-checked location (e.g., specific school within a school district).
       
---------------------------------------------------------------------------------------------
* * * General Checklist * * *
 
General Checklist
         Select All That Apply :
X
Proposed Start Date (cannot be before IRB approval):
August 2016
X
Sponsored Project (Check if you will be funded OR if you have or plan to submit a grant application in
association with this protocol)
NSF Sponsored (Please upload mandatory Data Management Plan in the Attachment section)
FDA or EPA-regulated research.  Please contact the CSU Quality Assurance Manager, Cat Bens, at 970-
491-5445 to determine if your study is under Good Laboratory, Good Clinical, or Good Manufacturing
Practices (GLP, GCP, GMP).
 Training Grant
Clinical Trial.  To register your trial on Clinicaltrials.gov, please contact Cat Bens, CSU Quality Assurance
Manager and Clinical Trails Administrator at:  970-491-5445.
Project is associated with the Colorado School of Public Health - CSPH(faculty and/or student)
Cooperating/Collaborating Institution(s) Institution
where recruitment will occur OR Institution where
Collaborating PI will conduct associated research.
Interview
X
Questionnaire/Survey
X
 Subjects will be compensated for participation
Thesis or Dissertation Project
ÃÂ Radioisotopes/radiation-producing machines, even if standard of care.  Please contact Jim Abraham,
Radiation Safety Officer for questions related to use of all radiation-producing machine:  970-491-3736;
james.abraham@colostate.edu.  Upload your radiation-use approval  (if available) or your Radiation Safety
Training certificate in the attachment section.
X
Human blood, cells, tissues, or body fluids. You will need to obtain IBC approval if you check this box. For
information regarding IBC approval, contact Christine Johnson, IBC Coordinator:
christine.johnson@colostate.edu
 Tissues to be stored for future research projects
 Tissues to be sent out of this institution as part of a research agreement
Human Embryos. You will need to obtain IBC approval if you check this box. For information regarding IBC
approval, contact Christine Johnson, IBC Coordinator:  christine.johnson@colostate.edu
Human Embryonic Cells? Provide NIH Code Number(s)
or state that no federal funding will be used to support
this research. You may need to obtain IBC approval if
you check this box. For information regarding IBC
approval, contact Christine Johnson, IBC Coordinator:
christine.johnson@colostate.edu
 Use of Patient-related equipment? If Yes, specify what equipment is being used.
Medical equipment used for human patients/subjects also used on animals. For questions regarding animal

Page 6 of 25
 
use approval, contact Elaine Kim, IACUC Senior Coordinator:  491-0236
Protocol involves studying potentially addicting drugs. For questions regarding approval for possession of
controlled substances, contact Chris Giglio, DRC Coordinator:  491-4830; Chris.Giglio@colostate.edu.
Investigational drugs, reagents, or chemicals (IND)
 Commercially available drugs, reagents, or other chemicals administered to subjects (even if they are not
being studied)
Investigational Device (IDE)
Cancer Subjects (e.g., clinical trials, behavior/prevention) or Cancer Tissues (e.g., blood, cells, body fluids).
You may need to obtain IBC approval if you check this box. For information regarding IBC approval, contact
Christine Johnson, IBC Coordinator:  christine.johnson@colostate.edu
Other (clarify in text box to the right)
---------------------------------------------------------------------------------------------
* * * Funding * * *
 
Please complete this section if:  1. This protocol will be funded, 2. You have submitted or will submit a grant
application associated with this protocol.  Please be sure to input your PASS/SP1 number to assist Sponsored
Programs in setting up an account for your funds.
If this protocol is funded by the NIH or NSF, or will lead to the regulatory involvement of the FDA or EPA, please
be certain you are cognizant of any specific regulatory requirements for data acquisition, storage, retention and
sharing, as well as research expenditure allowability, with regard to this IRB protocol.
 
Funding Checklist
NONE
  
  
NOTE: Applicable Federal Grant Application, including competing renewals, must be attached in the
Attachment Section (#16). Applicable investigator's brochure and sponsor's protocol must also be
attached in section #16 for all industry-sponsored clinical trials.
 
Funding - Grants/Contracts
Funding - Fellowships
Funding - Other
 
Gift Funding
Dept. Funding
Other Funding
Other Fund Name
CSU Crowdfunding Charge
Account #, if known
72153
---------------------------------------------------------------------------------------------

Page 7 of 25
 
* * * Expedited Paragraphs * * *
 
PLEASE READ:  This online application is for projects that will be reviewed by the IRB via the expedite or full-
board review process.  The criteria for expedited review are listed below. Review and check what expedite
criteria is/are appropriate for your project. NOTE:  If your research involves or may involve greater than minimal
risk, an element of deception, or is FDA-regulated research, do NOT check any of the expedited criteria listed
below.  Your protocol will then be reviewed by the full-board at their next regularly scheduled meeting.  If your
project meets the exempt criteria, please submit your exempt application via email to:
RICRO_IRB@mail.colostate.edu.  Information regarding exempt applications can be found here:
http://ricro.colostate.edu/IRB/ExemptReview.html
 
  Expedite Criteria:
 
1.
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
 
a) 
Research on drugs for which an investigational new drug application (21 CFR Part 31,32) is
not required. (Note: Research on marketed drugs that significantly increases the risks or
decreases the acceptability of the risks associated with the use of the product is not eligible
for expedited review.)
 
b) 
Research on medical devices for which                                                                                       
                             
 
      i) 
An investigational device exemption application (21 CFR Part 812) is not required; or
      ii) 
The medical device is cleared/approved for marketing and the medical device is being used in
accordance with its cleared/approved labeling.
 
2.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
 
a) 
From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the
amounts drawn may not exceed 550 ml in an 8- week period and collection may not occur
more frequently than 2 times per week; or
 
b) 
From other adults and children, considering the age, weight, and health of the subjects, the
collection procedure, the amount of blood to be collected, and the frequency with which it will
be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3
ml per kg in an 8-week period and collection may not occur more frequently than 2 times per
week.
 
3.
Prospective collection of biological specimens for research purposes by non-invasive means.
 
4.
Collection of data through non-invasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited
review, including studies of cleared medical devices for new indications.)
 
Examples:
a) 
Physical sensors that are applied either to the surface of the body or at a distance and do not
involve input of significant amounts of energy into the subject or an invasion of the subject's
privacy;
b) 
Weighing or testing sensory acuity;                                                                                              
           
c) 
Magnetic resonance imaging;                                                                                                      
     
d) 
Electrocardiography, electroencephalography, thermography, detection of naturally occurring

Page 8 of 25
 
radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow,
and echocardiography;
e) 
Moderate exercise, muscular strength testing, body composition assessment, and flexibility
testing where appropriate given the age, weight, and health of the individual.
 
5.
Research involving materials (data, documents, records, or specimens) that have been collected, or
will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE:
Some research in this paragraph may be exempt from the HHS regulations for the protection of
human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
 
6.
Collection of data from voice, video, digital, or image recordings made for research purposes.
 
7.
Research on individual or group characteristics or behavior(including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and
social behavior) or research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in
this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR
46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
 
 
---------------------------------------------------------------------------------------------
* * * Purpose,Study Procedures,Background * * *
 
Original Protocol Number (e.g., 07-226H)
   
Title (Please indicate if the protocol title is different from the proposal title)
Medical marijuana and its effects on motor function in people with Multiple Sclerosis: An observational
case-control study.
 
      Complete Sections 1 - 16. Specify N/A as appropriate. Do not leave any required sections blank.
1. Purpose of the study
a)
Provide a brief lay summary of the project in <200 words.  The lay summary should be readily
understandable to the general public, and is, for example, what would be released to a newspaper if
requested.
Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom, e.g. spasticity
and pain, management. Unfortunately not much is known about its effects outside the treatment for these 2
symptoms. Several previous studies have suggested people with MS using medical marijuana have lower
levels of physical disability and improved walking abilities. A major limitation of these previous studies is
that the investigators used subjective measures of motor function. In this proposed observational case-
control study we plan to objectively measure multiple domains of motor function, such as: fatigue, strength,
and walking ability in people with MS who are smoking medical marijuana.. No marijuana will be brought
on to campus or given to participants. After an online screening and initial phone interview cases (medical
marijuana users (smokers)) and controls (non-users) will perform a battery of clinical testing over the
course of 3 sessions spread across a 3 week period. Participants will use a log to track their medical
marijuana use, which was identified as an area that needed more investigation during the NIH’s
symposium on marijuana and cannabinoids held at the NIH campus 22 and 23 March, 2016.
 
b)
What does the Investigator(s) hope to learn from the study?
We expect to identify alterations in motor performance between medical marijuana users (smokers) and
non-user who have MS. This line of inquiry will open up future research avenues into the long term
benefits and consequences of chronic medical marijuana usage for the treatment of physical impairments
in people with MS. We also hope to begin the formation of preliminary usage guidelines for people with MS
contemplating using medical marijuana for symptom management.
We hope to determine how regular cannabis use alters resting brain activity in people with MS.
 

Page 9 of 25
 
c)
Proposed Start Date (may not precede IRB approval date):
August 2016
 
2. 
Study Procedures (If this is a student project, the methods section of the thesis or dissertation proposal
must be attached in section #16 - Attachment section.)
 
a)
In lay language, describe all the procedures, from screening through end-of-study, that the human subject
must undergo in the research project, including study visits, drug treatments, randomization and the
procedures that are part of standard of care.  Please note: Do NOT respond "See Attachment Section." If
you would like to add tables, charts, etc., attach those files in the Attachment section (#16).
Prospective participants will be recruited from the Integrative Neurophysiology Laboratory’s (INPL)
participant database, the clinical practice of Dr. William Shaffer, Banner Health, Greeley CO, and through
advertisements in the Colorado and Wyoming Chapter of the National MS Society newsletters. All
experimental procedures will be performed in the INPL (Director: Thorsten Rudroff, PhD, FACSM).
Interested individuals will perform an initial screening via an online questionnaire, hosted by Qualtrics,
which has a contract with the College of Health and Human Sciences. Contact information for the
prospective participants’ information will be accessible only to the research staff according to HIPPA
regulations. After completion of the online screening form, INPL personal will contact eligible participants
via phone and establish 20 case/control matched pairs, 40 total participants. After the pair has been
identified INPL staff will schedule the participants’ first visit. Eligibility requirements for this study are:
medically diagnosed with MS, 30-75 years of age, Moderate disability (Patient Determined Disease Steps
score 2-6). Cases will verbally confirm their usage of medical marijuana before matching is conducted. We
will only recruit people with MS who smoke medical marijuana. Exclusion criteria include: relapse with the
last 60 days; high risk for cardiovascular disease (American College of Sports Medicine risk classification);
changes in disease modifying medications within the last 45 days; concurrent neurological/neuromuscular
disease, concurrent conditions unrelated to MS that would exacerbate fatigue (anemia, hypothyroidism,
shiftwork-related fatigue, B12 deficiency, major sleep disorder, or major depressive disorder); history of
traumatic brain injury, seizure disorders, hydrocephalus, traumatic brain injury; diabetes; hospitalization
within the last 90 days; alcohol dependence (>2 drinks per day); present history (last six months) of drug
abuse; and inability to understand/sign informed consent. Additional participants may be screened and
recruited if problems arise within a matched pair, e.g. participants drop out or are unable to meet time
commitments.
Medical Marijuana users will be asked to refrain from using cannabis for 8 hours prior to all testing and
training to prevent any behavioral/physiological effects of acute intoxication which result from THC.
The experimental protocol for this study consists of three testing sessions.
Session 1
Upon arrival to the Integrative Neurophysiology Lab (INPL) at CSU the investigators will explain the
protocol procedures and receive signed informed consent from the participants. After consent a urinalysis
assessment for Δ9-tetrahydrocannabinol (THC) will be performed to confirm case/control status. Next
participants will complete several questionnaires: Activities-specific Balance Confidence (ABC) Scale,
Fatigue Severity Scale (FSS), Beck’s Depression Inventory (BDI), the MS Quality of Life (MSQOL)-54
Instrument, the MOS Pain Effects Scale (PES), and the Numeric Rating Scale of Spasticity (NRS). After
the questionnaires are complete the participants will undergo a resting metabolic rate (RMR) test. For the
RMR participants will be in a supine position for approximately 50 minutes while their expired air is
captured and analyzed. Hand grip strength will be assessed using a hydraulic handgrip dynamometer.
Participants will perform the hand grip assessment in a seated position with the arms next to the torso and
the elbow flexed at 90 degrees with a neutral wrist position. Prior to the conclusion of the first session
participants will be introduced to the ActiGraph accelerometer. Participants will be asked to wear the
monitor for 7 days in between the first and second visits during the waking hours. During non-wear times,
participants will be asked to write any activities performed in a log. Participants will also be given a log to
track their medical marijuana usage and they will be asked to bring in any medical labels, labels only no
marijuana will be brought onto the CSU campus, so that THC content can be recorded by the
investigators. It is expected that the first visit will last between 2-3 hours.
Session 2
At least 7 full days after Session 1 participants will return to the INPL. During this visit participants will
perform the MS Functional Composite (MSFC), which consists of a 25 foot walk test (25FWT), the 9 hole
peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT). For the 25FWT participants will be
asked to walk 25 feet as quickly, but as safely as possible. This will be performed in a cordoned off hallway
with the length clearly marked off. Participants will begin after a short countdown and the time it takes to
complete will be measured with a handheld stop watch. Two trials of the 25FWT will be performed and

Page 10 of 25
 
INPL staff will walk alongside the participants to minimize the risk of falling. Next the 9HPT will be
performed. Participants will begin w/ their dominant hand and quickly move 9 cylindrical plastic pegs from
a concave dish into 9 holes. Pegs will be placed in the holes 1 at a time and once all pegs are in a hole the
participants will remove the pegs and return them to the dish. Each hand will be tested twice and the time
of completion will be recorded with a handheld stop watch. The PASAT will be performed after the 9HPT.
This test consists of the playback of a series of pre-recorded numbers spoken on a computer. The
participants are asked to add the last two spoken numbers which occur every three seconds for a 2 minute
period of time. The number of correct answers is recorded by the test moderator. (Previously performed in
IRB# 14-5152H)
After the MSFC is concluded participants will rest for at least 5 min before balance testing is performed. To
test balance participants will perform the modified clinical test of sensory interaction on balance (mCTSIB).
For this test participants will be asked to stand with their feet together with no shoes on. They will stand
quietly in this position for 30 sec under 4 conditions: eyes open, eyes closed, eyes open on a foam pad,
and eyes closed on a foam pad. At the conclusion of balance testing participants will rest in a seated
position for at least 5 min and the instruction for the next test will be given/demonstrated.
After balance assessment strength testing of the right and left legs will be performed. Participants will
perform strength testing in a seated position with their knee and hip joints at 90 degrees of flexion. A linear
force transducer will be attached to the participant’s ankle. Once the participant is in the proper position
they will be instructed to perform a series of isometric maximal voluntary contractions (MVC). Participants
will be instructed to increase the force of the knee extensors over a period of 3 sec, hold their maximum
force output for 3 seconds, and then relax. Participants will perform subsequent trials after at least 1 min of
rest. Once the participants’ MVC no longer increases in force the investigators will unstrap the person’s leg
and test the other side. (Previously performed in IRB# 14-5152H)
The next procedure to be performed will be the 6 minute walk test (6MWT). For this test participants will be
asked to walk as far as they can in 6 minutes. The test will be performed in a cordoned off hallway with 2
cones placed 30 meters apart. Once the participants begin walking, a timer will be started and the distance
covered every min will be recorded. Participants are allowed to stop and rest during the test if required.
Every minute during the walk test participants will be asked their rating of perceived exertion (RPE, 0-10
scale).
Session 2 will last approximately 2-3 hours.
Session 3
Force steadiness will be tested during the third visit for both the left and right quadriceps. Three MVC will
be performed to verify strength tested during visit 2. Participants will perform 2 trials at 3 different force
levels (5, 25, and 50% MVC), in a randomized order, holding each force level for 20 seconds. At least 1
minute rest will be given between each trial. Tests will be performed on the right and left legs. Surface
electromyography will be performed on the muscles of the quadriceps femoris and hamstrings (vastus
lateralis, vastus medialis, rectus femoris, and biceps femoris). Visual feedback will be provided to the
participants on a computer monitor positioned at eye level approximately 1 meter away.
The last test performed will be the timed-up-and-go (TUG), which consists of rising from a chair, walking 3
meters, returning to the starting point, and sitting down. During this test INPL staff will walk near the
participants to provide support if needed. The participants are instructed to complete the task as quickly as
possible. The time it takes them to complete the task will be measured with a handheld stopwatch.
Session 3 will last approximately 2 hours
 
b)
Explain why human subjects must be used for this project.
The goal of this project is to determine how medical marijuana affects aspects of motor performance in
people with MS. Therefore all clinical testing needs to be performed in the patient population that is being
studied.
 
c)
Alternative Procedures. If the proposed study is a clinical trial of a drug, vaccine, device or treatment,
describe alternative procedures, if any, that might be advantageous to the subject. Describe the important
potential risks and benefits associated with the alternative procedure(s) or course(s) of treatment. Any
standard treatment that is being withheld must be disclosed. This information must be included in the
consent form.
N/A
 

Page 11 of 25
 
d)
If the proposed study is a clinical trial of a drug, vaccine, device or treatment, will it be possible to continue
the more (most) appropriate therapy for the subject(s) after the conclusion of the study?
N/A
 
e)
Study Endpoint. If the proposed study is a clinical trial of a drug, vaccine, device or treatment, what are the
guidelines or end points by which you can evaluate the alternative treatments during the study? If one
treatment proves to be clearly more effective than another (or others) will the study be terminated before
the projected total subject population has been enrolled? When will the study end if no important
differences are detected?
N/A
 
f)
State if deception will be used. If so, provide a rationale and describe debriefing procedures. Submit a
debriefing script in the Attachment Section (#16).
N/A
 
3. Background
a)
Describe past experimental and/or clinical findings leading to the formulation of the study, if applicable.
Several participants in our previous study investigating the predictors of physical activity in patients with
MS were using cannabis products. When these individuals were compared to matched individuals they
seemed to perform better on the tests measuring motor function. From this initial data, only 4 cannabis
users, we became interested in determining if medical marijuana would improve physical function and
fatigue in people with MS. Currently we are performing an anonymous online survey hosted through the
Qualtrics website investigating cannabis use in people with neurological disorders (CSU IRB# 126-16H ).
To date, over 450 peoples have taken this survey, with approximately 40% stating they currently use
cannabis based products for symptom management.
 
b)
Describe any animal experimentation and findings leading to the formulation of the study, if applicable.
---------------------------------------------------------------------------------------------
* * * Radioisotopes or Radiation Machines * * *
 
 
You selected NO for Radioisotopes in the General Checklist. If you would like to add Radioisotopes, change the
selection to YES in general Checklist.
 
4. 
Radioisotopes or Radiation Machines Please note: For projects requiring radiation procedures, please
contact the CSU Radiation Control Office (RCO). For more information see:
http://www.ehs.colostate.edu/WRad/Home.aspx :
 
 
a) 
If applicable, summarize in lay language the radiographic diagnostic and therapeutic procedures
associated with this protocol.
N/A
  b) 
Are the radiation procedures being performed a normal part of the clinical management for the medical
condition that is under study (Standard of Care) or are the procedures being performed because the
research subject is participating in this project (extra CT scans, more fluoroscopy time, additional Nuclear
Medicine Studies, etc.,) (Not Standard of Care)? If some procedures are Standard of Care and some are
Not Standard of Care, check both boxes.
 
  
NOT STANDARD OF CARE
STANDARD OF CARE
  
If it is not standard of care, complete the rest of
this section. Provide the CSU RCO approval
If it is only standard of care, skip the rest of this
section.

Page 12 of 25
 
this section. Provide the CSU RCO approval
information
section.
 
 
CSU Radiation Control Office approved protocol number:
 
 
CSU Radiation Control Office protocol approval date:
 
For more information, see the RCO website at:<a href='http://www.ehs.colostate.edu/Wrad/home.aspx'
target=_blank >http://www.ehs.colostate.edu/Wrad/home.aspx or Contact: James Abraham, Radiation
Safety Officer, at 970-491-3736.
---------------------------------------------------------------------------------------------
* * * Medical Equipment for Human Subjects and Laboratory Animals; Investigatiional Devices * * *
 
 
5. Medical Equipment for Human Subjects
 
  
If medical equipment is being used for human subjects/patients, describe this equipment and indicate if the
use is normal practice for the population under study. You may have already described this equipment in
the Study Procedures section. If you have already listed this information in the Study Procedures Section,
please do not duplicate this information here. In the space below, input N/A if not applicable, indicate if this
is already listed in the Study Procedures Section, or describe the equipment.
N/A
 
 
6. Investigational Devices
         Please list in the space below all Investigational Devices to be used on Subjects.
Investigational Devices
---------------------------------------------------------------------------------------------
* * * Drugs, Reagents, or Chemicals * * *
 
 
7. Drugs, Reagents, or Chemicals
 a)
Please list in the space below all investigational drugs, reagents or chemicals to be administered to
subjects during this study.
 
 b)
Please list in the space below all commercial drugs, reagents or chemicals to be administered to subjects
during this study.
 
 
Please read the IND Statements
---------------------------------------------------------------------------------------------
* * * Subject Population (a-g) * * *
 
 
8.  

Page 13 of 25
 
Subject Population - In the space below, please detail the participants that you are requesting to recruit
(include requested participant number and description of each group requested).  (Input N/A if not
applicable)
a)
Requested Participant Description (Include number of participants that you plan to study and description of
each group requested, if applicable).
We plan on recruiting 40 people with MS:  20 are regular cannabis users (smokers), 20 are not users, with
an estimate that approximately 5 from each group will not complete the study (i.e. drop out).
 
b)
What is the rationale for studying the requested group(s) of participants?
To investigate the effects of medical marijuana usage on physical function we will employ an observational
case-control design. Cases (MS medical marijuana users) will be compared to age, sex, and disease
duration matched controls (MS non-cannabis users). The research team has experience with all the
methods involved.
 
c)
If applicable, state the rationale for involvement of potentially vulnerable subjects to be entered into the
study, including minors, pregnant women, economically and educationally disadvantaged, or decisionally
impaired subjects. Specify the measures being taken to minimize the risks and the chance of harm to the
potentially vulnerable subjects.
N/A
 
d)
If women, minorities, or minors are not included, a clear compelling rationale must be provided. Examples
for not including minors: disease does not occur in children; drug or device would interfere with normal
growth and development; etc.
N/A
 
e)
State if any of the subjects are students, employees, or laboratory personnel. They should be presented
with the same written informed consent. If compensation is allowed, they should also receive it.
N/A
 
f) 
Describe how potential subjects will be identified for recruitment (e.g., chart review, referral from individual's
treating physician, those individuals answering an ad). How will potential participants learn about the
research and how will they be recruited (e.g., flyer, email, web posting, telephone, etc.)? Attach recruitment
materials in the Attachment Section (#16). Important to remember: potential subjects may not be contacted
before IRB approval.
Prospective participants will be recruited from the Integrative Neurophysiology Laboratory’s (INPL)
participant database, the clinical practice of Dr. William Shaffer, Banner Health, Greeley CO, and through
advertisements in the Colorado and Wyoming Chapter of the National MS Society newsletters. All
experimental procedures will be performed in the INPL (Director: Thorsten Rudroff, PhD, FACSM).
Interested individuals will perform an initial screening via an online questionnaire, hosted by Qualtrics,
which has a contract with the College of Health and Human Sciences. Contact information for the
prospective participants’ information will be accessible only to the research staff according to HIPPA
regulations. After completion of the online screening form, INPL personal will contact eligible participants
via phone and establish 20 case/control matched pairs, 40 total participants. After the pair has been
identified INPL staff will schedule the participants’ first visit.
 
g) 
If applicable, provide rationale for the inclusion of healthy volunteers in this study. Specify any risks to
which these healthy volunteers may possibly be exposed. Specify the measures being taken to minimize
the risks and the chance of harm to these volunteers.
N/A
---------------------------------------------------------------------------------------------
* * * Subject Population (h-m) * * *
 
 
8. Subject Population (Input N/A if not applicable)

Page 14 of 25
 
h)
Inclusion and Exclusion Criteria (e.g., Participants must have 20/20 vision, Participants must be 30-45
years of age, etc.)
 
 
  
   
Identify inclusion criteria.
Medically diagnosed with MS, 30-60 years of age, Moderate disability (Patient Determined
Disease Steps score 2-6). Cases will verbally confirm their usage of medical marijuana
(smokers) before matching is conducted.
 
 
  
   
Identify exclusion criteria.
Relapse with the last 60 days, high risk for cardiovascular disease (American College of Sports
Medicine risk classification), changes in disease modifying medications within the last 45 days,
concurrent neurological/neuromuscular disease, hospitalization within the last 90 days, and
inability to understand/sign informed consent. Additional participants may be screened and
recruited if problems arise within a matched pair, e.g. participants drop out or are unable to
meet time commitments.
•A condition unrelated to MS that would exacerbate fatigue, such as anemia, hypothyroidism,
shiftwork-related fatigue, B12 deficiency, major sleep disorder, or major depressive disorder
•Medical diagnosis or condition that  makes participating in exercise training dangerous, such
as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated
basal cell cancer), other neurological disorders, or pregnancy
•History of heart attack or current diagnosis of cardiovascular disease
•History of seizure disorders (or on medications known to lower seizure threshold),
hydrocephalus (buildup of fluid in the brain), or diabetes
•Alcohol dependence or abuse (>2 drinks/day), or present history (last six months) of drug
abuse
•History of significant traumatic brain injury or hydrocephalus
•Pregnancy
•Recent hospitalization (within the last 3 months) or enforced bed
   rest/sedentary state.
 
i)
Describe your screening procedures. Attach your screening document(s) (e.g., health history
questionnaire) in the Attachment Section (#16).
Prospective participants will be recruited from the Integrative Neurophysiology Laboratory’s (INPL)
participant database, the clinical practice of Dr. William Shaffer, Banner Health, Greeley CO, and through
advertisements in the Colorado and Wyoming Chapter of the National MS Society newsletters. All
experimental procedures will be performed in the INPL (Director: Thorsten Rudroff, PhD, FACSM).
Interested individuals will perform an initial screening via an online questionnaire, hosted by Qualtrics,
which has a contract with the College of Health and Human Sciences. Contact information for the
prospective participants’ information will be accessible only to the research staff according to HIPPA
regulations. After completion of the online screening form, INPL personal will contact eligible participants
via phone and establish 20 case/control matched pairs, 40 total participants. After the pair has been
identified INPL staff will schedule the participants’ first visit.
 
j)
Describe how you will be cognizant of other protocols in which subjects might be participating. Please
explain if subjects will be participating in more than one study.
We will ask participants whether they are involved in other studies. If they are, we make sure that there are
no interference.
 
k)
Compensation. Explain the amount and schedule of compensation, if any, that will be paid for participation
in the study. Compensation includes food, gift cards, money, tokens, etc. Include provisions for prorating
payment, if applicable.  Compensation should be prorated if several activities are involved for different time
periods (e.g., $10 for session #1, and $10 for session #2).
Participants will receive compensation for their time in the lab totaling $75.00. Participants will receive a
$20, $25, and $30 prepaid Visa gift card at the conclusion of the 1st, 2nd, and 3rd session respectively.
 
l)
Costs. Please explain any costs that will be charged to the subject.
No costs for participants.

Page 15 of 25
 
 
m)
Estimate the probable duration of the entire study. This estimate should include the total time each subject
is to be involved and the duration the data about the subject is to be collected (e.g., This is a 2-year study.
Participants will be interviewed 3 times per year; each interview will last approximately 2 hours.  Total
approximate time commitment for participants is 12 hours).  These times should be consistent with the time
commitment listed on the consent document.
The probable duration of the study will be 12 months.
1. Visit: 2-3 hours
2. Visit 2-3 hours
3. Visit 2 hours
---------------------------------------------------------------------------------------------
* * * Risks * * *
 
 
9. Risks (Input N/A if not applicable)
     
US Department of Health & Human Services (HHS) Regulations define a subject at risk as follows: "...any
individual who may be exposed to the possibility of injury, including physical, psychological, or social injury,
as a consequence of participation as a subject in any research, development, or related activity which
departs from the application of those accepted methods necessary to meet his needs, or which increases
the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of
service."
 
 a) 
PI's evaluation of the overall level of Risk. (Please check one: minimal or > minimal.)
Y
Minimal (everyday living)
> Minimal (greater than everyday living)
 
 b)   
For the following categories include a scientific estimate of the frequency, severity, and reversibility of
potential risks. Wherever possible, include statistical incidence of complications and the mortality rate of
proposed procedures. Where there has been insufficient time to accumulate significant data ON risk, a
statement to this effect should be included. (In describing these risks in the consent form to the subject, it is
helpful to use comparisons which are meaningful to persons unfamiliar with medical terminology.) Address
any risks related to:
 
 
   
   
1.   
Use of investigational devices. Please include the clinical adverse events (AEs) associated with
each of the devices with an indication of frequency, severity and reversibility. This information
can often be found in the Investigator(s) brochure.
N/A
 
 
   
   
2   
Use of investigational drugs. Please include the clinical AEs associated with each of the drugs
with an indication of frequency, severity and reversibility. This information can often be found in
the Investigator(s) brochure.
N/A
 
 
   
   
3   
Use of commercially available drugs, reagents or chemicals. Please include the clinical AEs
associated with each of the drugs with an indication of frequency, severity and reversibility. This
information can often be found in the package insert provided by the manufacturer.
N/A

Page 16 of 25
 
 
 
   
   
4   
When performing procedures, please include all investigational, non-investigational and non-
invasive procedures (e.g., surgery, blood draws, treadmill tests).
Motor Tasks
The most likely adverse event to happen during this protocol is a fall. During the performance of
all tests research personnel will be within an arms distance of the participants to provide
support if needed. The hallway in which the 6 minute walk test will be performed also has hand
rails that can be used at any time if needed. During the step test a hand rail will also be
available. All research staff of certified in CPR, AED, and First Aid by the American Red Cross.
All participants will be low or moderate risk for an adverse cardiac event as classified by the
American College of Sports Medicine. In the case of such an event emergency personal will be
notified using standard Human Performance and Clinical Research Laboratory procedures.
Minor muscle pain/stiffness/cramps can occur during the performance of the different strength
measurements. If this occurs, the participant will be allowed to move/stretch/massage the
muscle. If pain is increased or participant is uncomfortable completing the strength testing
those assessments will be skipped. Minor skin irritation can also occur from the surface
electromyography electrodes. After and area is properly prepped, if the participant has a skin
reaction the electrodes will not be utilized and the task will be performed sans
electromyography.
 
 
   
   
5  
Radioisotopes/radiation-producing machines(e.g., X-rays, CT scans, fluoroscopy).
N/A
 
 
c)      
For the following categories, include an estimate of the potential risk, if applicable.
 
 
   
   
1.   
Physical well-being.
Motor tasks
The most likely adverse event to happen during this protocol is a fall. During the performance of
all tests research personnel will be within an arms distance of the participants to provide
support if needed. The hallway in which the 6 minute walk test will be performed also has hand
rails that can be used at any time if needed. During the step test a hand rail will also be
available. All research staff of certified in CPR, AED, and First Aid by the American Red Cross.
All participants will be low or moderate risk for an adverse cardiac event as classified by the
American College of Sports Medicine. In the case of such an event emergency personal will be
notified using standard Human Performance and Clinical Research Laboratory procedures.
Minor muscle pain/stiffness/cramps can occur during the performance of the different strength
measurements. If this occurs, the participant will be allowed to move/stretch/massage the
muscle. If pain is increased or participant is uncomfortable completing the strength testing
those assessments will be skipped. Minor skin irritation can also occur from the surface
electromyography electrodes. After and area is properly prepped, if the participant has a skin
reaction the electrodes will not be utilized and the task will be performed sans
electromyography.
 
 
   
   
2.   
Psychological well-being.
N/A
 
 
   
   
3.   
Economic well-being.
N/A

Page 17 of 25
 
 
 
   
   
4.   
Social well-being.
N/A
 
 d) 
In case of overseas research, or working with a specific race/ethnicity in the United States, provide
background on what experience the Investigator(s) have with the proposed population. Describe
qualifications/preparations that enable the Investigator(s) to evaluate cultural appropriateness and
estimate/minimize risks to subjects.
N/A
 
 e) 
Special Precautions. Describe the planned procedures for protecting against or minimizing potential risks. If
appropriate, include the standards for termination of the participation of the individual subject. Discuss
plans for ensuring necessary medical or professional intervention in the event of adverse effects to the
subjects.
N/A
 
 f) 
Data Safety Monitoring                                                                                          
    
N
Is there a Data Safety Monitoring Board (DSMB)?
 
 
   
   
   
If yes, describe its role and indicate who set up the Data Safety Monitoring Board (e.g., sponsor
or Protocol Director).
 
 
   
   
   
Describe the data and safety monitoring plan developed to ensure the safety of participants and
the validity and integrity of research data. Monitoring should be commensurate with risks and
with the size and complexity of the trials.
---------------------------------------------------------------------------------------------
* * * Benefits, Procedures to Maintain Confidentiality * * *
 
 
10. Benefits (Input N/A if not applicable)
a)
Describe the potential benefit(s) to be gained by the subjects. If there is no direct benefit to the subjects
describe how the results of the study may benefit society or a particular group.
There is no direct benefit from participating in this research study to the individual research participants.
The knowledge derived from this study will allow people with Multiple Sclerosis the ability to make a more
informed decision regarding medical marijuana use for disease symptom management. Currently there are
no scientifically based guidelines for the use of medical marijuana for this population. This research
protocol will provide the groundwork to establish these guidelines allowing medical practitioners and
patients to make informed decisions about the possible benefits and consequences of medical marijuana
use.
 
11. Procedures to Maintain Confidentiality
a)
Describe the procedures that protect the privacy of the subjects and maintain the confidentiality of the data.
If a linked list is used, explain when the linked list will be destroyed.  Provide a sample of the code that will
be used, if applicable.
Personal identification is limited to the initial online screening. After eligibility has been determined,

Page 18 of 25
 
prospective participants will be assigned a unique study ID, example: MSMMJ-###. Subsequent to the
assignment of the study ID, all data collected will be collected under the individual’s study ID only. A list
corresponding personal data to study ID will be kept in a locked filing cabinet within theINPL where access
is restricted to authorized key holders. All data will be kept for a minimum of 3 years according to
University / State / Federal regulations. All hard copy data will be destroyed via burning at the time that
study data is no longer needed/required.
 
b)
If information derived from the study will be provided to the subject's personal physician, a government
agency, or any other person or group (other than the research team), describe to whom the information will
be given and the nature of the information, if applicable.
N/A
 
c)
Specify where and under what conditions study data will be kept, how samples will be labeled, who has
access to the data, and what will be available and to whom.  Federal regulations require that study data
and consent documents be kept for a minimum of three (3) years after the completion of the study by the
PI.  For longitudinal projects and federally regulated studies, the PI may be required to keep the data and
documents for a longer time period.
Electronic data will be stored on the university computer network with access restricted to research
personnel. Computers are password protected and require direct on-campus to connections for access.
Hard copy information will be stored in a locked filing cabinet in the Integrative Neurophysiology
Laboratory. Access to the room is restricted to authorized key holders (Director: Thorsten Rudroff,
Students: John Kindred, Nathan Ketelhut). Afterhours access to the building and the department space is
restricted to authorized personnel (Department faculty and staff) between the hours of 1700-0700. All data
will be kept on hand for at least 3 years. After which hard copies will be destroyed and electronic data
deleted from the University’s computer system via system administrators. Any backups containing data will
be cleaned and sanitized using University approved procedures by the College of Health and Human
Sciences IT staff.
Urine samples will be collected for confirmation of participant’s group status (case versus control). After
immediate confirmation with testing strips the biological samples will be disposed in approved biological
sample containers per University / State / Federal regulations.
---------------------------------------------------------------------------------------------
* * * Potential Conflict of Interest * * *
 
 
12. Potential Conflict of Interest
Although you have already submitted CSU's official Conflict of Interest form (FCOI/COI/COC) to the
University, it is the IRB's responsibility to ensure that conflicting interests related to submitted protocols do
not adversely affect the protection of participants or the credibility of the human research protection program
at CSU. Please answer questions a-d below.  Please note that if you indicate that you have a potential
financial or professional conflict of interest in relation to this protocol, your CSU FCOI/COI/COC Reporting
Form must reflect this potential conflict.  Link to CSU's Conflict of Interest policy:
:http://www.facultycouncil.colostate.edu/files/manual/sectiond.htm#D.7.7
a)
N
In connection with this protocol, do you or any of the protocol investigators or their
immediate family members (i.e., spouse and legal dependents, as determined by the IRS)
have a potential financial or professional conflict of interest?
b)
N/A
If you do have a potential conflict of interest, is this reported in your current
FCOI/COI/COC?
c)
N/A
If you do have a potential conflict of interest, is there a management plan in place to
manage this potential conflict?
d)
N/A
If you do have a potential conflict of interest, is this potential conflict of interest included in
your consent document (as required in the Management Plan)?
 
If you have reported a possible conflict of interest, the IRB will forward the title of this protocol to your Research
Associate Dean to complete your COI file. 
 

Page 19 of 25
 
For more information on CSU's policy on Conflict of Interest, please see the Colorado State University
Academic Faculty and Administrative Professional Manual Sections D.7.6 & D.7.7.
:http://www.facultycouncil.colostate.edu/files/manual/sectiond.htm#D.7.7
 
Link to CSU's Conflict of Interest Policy: http://www.provost.colostate.edu/index.asp?url=faculty_affairs.
---------------------------------------------------------------------------------------------
* * * Informed Consent * * *
 
 
13. Informed Consent
NOTE: In order to complete this protocol, you must upload either a Consent Form or an Alteration of
Consent Form (i.e., Cover Letter or Verbal Script) OR (if neither of those apply to your project) you must
complete the Waiver of Consent information.
In the space below, please provide consent process background information for each Consent Form(s),
Alteration of Consent Form(s), or Waiver(s).
Informed Consent
  Title
Control Consent Am 4 12May2017
  Consent Information Type
Consent
  Sponsor's Consent Version Number: (if any)
Consent Form Template
X Attachment
 
Consent_Control_Group_2017051
2 (2)
<a href='http://ricro.colostate.edu/IRB/ConsentAssentTemplates.html' target=_blank Consent Form
Samples
Who is obtaining consent? The person obtaining consent must be knowledgeable about the study and
authorized by the PI to consent human subjects.
How is consent being obtained?
What steps are you taking to determine that potential subjects are competent to participate in the decision-
making process?
  Title
MMJ Consent Am 4 12May2017
  Consent Information Type
Consent
  Sponsor's Consent Version Number: (if any)
Consent Form Template
X Attachment
 
Consent_MMJ_Group_20170512
(1)
<a href='http://ricro.colostate.edu/IRB/ConsentAssentTemplates.html' target=_blank Consent Form
Samples
Who is obtaining consent? The person obtaining consent must be knowledgeable about the study and
authorized by the PI to consent human subjects.
How is consent being obtained?
What steps are you taking to determine that potential subjects are competent to participate in the decision-
making process?
---------------------------------------------------------------------------------------------

Page 20 of 25
 
* * * Assent Background * * *
 
 
14. Assent Background  (Complete if applicable)
All minors must provide an affirmative consent to participate by signing a simplified assent form, unless the
Investigator(s) provides evidence to the IRB that the minor subjects are not capable of assenting because of
age, maturity, psychological state, or other factors.
See sample consent/assent forms at <a href=http://ricro.colostate.edu/IRB/ConsentAssentTemplates.html
target=_blank > http://ricro.colostate.edu/IRB/ConsentAssentTemplates.html
Provide assent process background information, in the space below, for each Assent Form, Alteration Form
(i.e., Cover Letter or Verbal Script), and Waiver.
Assent  Background
---------------------------------------------------------------------------------------------

Page 21 of 25
 
* * * HIPAA * * *
 
 
15. HIPAA
Are you using PHI*? (See definition below)
Y
Colorado State University is a hybrid entity and does not have a research-related HIPAA policy. If you will be
working with a HIPAA covered entity (e.g., Poudre Valley Health System), you will need to follow their HIPAA
guidelines. If your project will involve a HIPAA-regulated entity, in the Attachment section (#16) please attach that
entity's required HIPAA consent and/or each waiver of authorization or alteration of authorization requested (e.g.,
waiver of authorization for access to medical records). Include HIPAA authorization language in the consent
document(s) as appropriate (e.g., when enrolling subjects).  
*Protected Health Information (PHI) is health information with one or more of the following identifiers. For
more information see: http://www.hhs.gov/ocr/hipaa/
  1.
Names
  2.
Social Security numbers
  3.
Telephone numbers
  4.
All geographic subdivisions smaller than a State, including street address, city, county, precinct,
zip code, and their equivalent geocodes, except for the initial three digits of a zip code, if,
according to the current publicly available data from the Bureau of the Census: (1) The
geographic unit formed by combining all zip codes with the same three initial digits contains
more than 20,000 people; and (2) The initial three digits of a zip code for all such geographic
units containing 20,000 or fewer people is changed to 000
  5.
All elements of dates (except year) for dates directly related to an individual, including birth date,
admission date, discharge date, date of death; and all ages over 89 and all elements of dates
(including year) indicative of such age, except that such ages and elements may be aggregated
into a single category of age 90 or older
  6.
Fax numbers
  7.
Electronic mail addresses
  8.
Medical record numbers
  9.
Health plan beneficiary numbers
10.
Account numbers
11.
Certificate/license numbers
12.
Vehicle identifiers and serial numbers, including license plate numbers
13.
Device identifiers and serial numbers
14.
Web Universal Resource Locations (URLs)
15.
Internet Protocol (IP) address numbers
16.
Biometric identifiers, including finger and voice prints
17.
Full face photographic images and any comparable images; and
18.
Any other unique identifying number, character, or code (note this does not mean the unique
code assigned by the Investigator(s) to code the research data)
---------------------------------------------------------------------------------------------
* * * Attachments * * *
 
16. Attachments
Attach relevant documents here. These could include: Collaborating Investigator's IRB approval and
approved documents; Conflict of Interest information; Debriefing Script; Grant/Sub-contract; HIPAA
Authorization Form from HIPAA-covered entity; Interview/Focus Group Questions; Investigator's Brochure;
Letters of Agreement/Cooperation from organizations who will help with recruitment; Methodology section of
associated Thesis or Dissertation project; Questionnaires; Radiation Control Office approval material;
Recruitment Material (e.g., flyers, email text, verbal scripts); Sponsor's Protocol; Surveys; Other files
associated with the protocol (you can upload most standard file formats: xls, pdf, jpg, tif, etc.)  Please be
sure to attach all documents associated with your protocol. Failure to attach the files associated with the

Page 22 of 25
 
protocol may result in this protocol being returned to you for completion prior to being reviewed. Students:
Be sure to attach the Methods section of your thesis or dissertation proposal. If this protocol is associated
with a grant proposal, please remember to attach your grant.
To update or revise any attachments, please delete the existing attachment and upload the revised document to
replace it. 
Document Type
Recruitment Material (e.g., flyers, email text, verbal
scripts)
Attachment
Recruitment_flyer
Document Name
Recruitment_flyer
Document Type
Other Protocol Material
Attachment
MSQOL54_995
Document Name
MSQOL54_995
Document Type
Other Protocol Material
Attachment
MSFC_Manual_and_Forms
Document Name
MSFC_Manual_and_Forms
Document Type
Other Protocol Material
Attachment
MMJ_use_log
Document Name
MMJ_use_log
Document Type
Other Protocol Material
Attachment
FSS
Document Name
FSS
Document Type
Other Protocol Material
Attachment
Beck_Depression_Inventory
Document Name
Beck_Depression_Inventory
Document Type
Other Protocol Material
Attachment
Activity LOG
Document Name
Activity LOG
Document Type
Other Protocol Material
Attachment
activities_specific_balance_scale_nov_5_2012
Document Name
activities_specific_balance_scale_nov_5_2012
Document Type
Recruitment Material (e.g., flyers, email text, verbal
scripts)
Attachment
Online_screening
Document Name
Online_screening

Page 23 of 25
 
Document Type
Letters of Agreement.Cooperation
Attachment
Letter_Dr. Shaffer
Document Name
Letter_Dr. Shaffer
Document Type
HIPAA Authorization Form
Attachment
HIPAA Release generic
Document Name
HIPAA Release generic
Document Type
Other Protocol Material
Attachment
MOS Pain Effects Scale (PES)
Document Name
MOS Pain Effects Scale (PES)
Document Type
Other Protocol Material
Attachment
NRS_Spasticity_Figure 1
Document Name
NRS_Spasticity_Figure 1
Document Type
Letters of Agreement.Cooperation
Attachment
Letter of Support Dr. Ross, IMPACT Network
Document Name
Letter of Support Dr. Ross, IMPACT Network
Document Type
Letters of Agreement.Cooperation
Attachment
IMPACT 2016 Report Public Final
Document Name
IMPACT 2016 Report Public Final
Document Type
Recruitment Material (e.g., flyers, email text, verbal
scripts)
Attachment
Rudroff_Recruitment_flyer_MMJ (2) Qaualtric web
address
Document Name
Rudroff_Recruitment_flyer_MMJ (2) Qaualtric web
address
Document Type
Other Protocol Material
Attachment
Rehab Measures - Modified Clinical Test of Sensory
Interaction...[3726]
Document Name
Rehab Measures - Modified Clinical Test of Sensory
Interaction...[3726]
Document Type
Collaborating Investigator's IRB approval and
associated documents
Attachment
Rudroff NTF 16.6685HH
Document Name
Rudroff NTF 16.6685HH
---------------------------------------------------------------------------------------------

Page 24 of 25
 
* * * Obligations * * *
 
 
Obligations (Researcher's Responsibilities)
 
The Principal Investigator is ultimately responsible for the conduct of the project. Obligations of the Principal
Investigator are:
 
Conduct the research involving human subjects as presented in the protocol, including modifications, as
approved by the Department and Institutional Review Board. Changes in any aspect of the study (for example
project design, procedures, consent forms, advertising materials, additional key personnel or subject populations)
will be submitted to the IRB for approval before instituting the changes (PI will submit the "Amendment/Revision"
form);
 
Provide all subjects a copy of the signed consent form, if applicable. Investigators will be required to retain signed
consent documents for three (3) years after close of the study;
 
Maintain an approved status for Human Subjects Protection training. Training must be updated every three (3)
years (Contact RICRO to check your current approval/renewal dates). For more information:  Human Subjects
Training Completed?
 
Submit either the "Protocol Deviation Form" or the "Report Form" to report protocol Deviations/Violations,
Unanticipated Problems (UPs) and/or Adverse Events (AEs) that occur in the course of the protocol. Any of these
events must be reported to the IRB as soon as possible, but not later than five (5) working days.  Note that if an
event resulted in life threatening injury or death OR an event resulted in substantive harm to the safety, rights or
welfare to human subjects, this must be reported to the IRB within 24 hours;
 
Submit the "Continuing Review" Form in order to maintain active status of the approved protocol. This form must
be submitted annually at least four (4) weeks prior to expiration, five (5) weeks for protocols that require full
review. If the protocol is not renewed before expiration, all activities must cease until the protocol has been re-
reviewed;
 
Notify the IRB that the study is complete by submitting the "Final Report" form.
 
  
  
X
The Principal Investigator has read and agrees to abide by the above obligations.
---------------------------------------------------------------------------------------------
* * * Event History * * *
Event History
Date
Status
View Attachments
Letters
05/26/2016
NEW FORM CREATED
06/28/2016
NEW FORM SUBMITTED
Y
07/05/2016
NEW FORM PANEL
ASSIGNED
07/14/2016
NEW FORM REVIEWER(S)
ASSIGNED
07/18/2016
NEW FORM REVIEWER(S)
ASSIGNED

Page 25 of 25
 
08/01/2016
NEW FORM REVIEWER(S)
ASSIGNED
08/17/2016
NEW FORM MOVED
08/17/2016
NEW FORM APPROVED
Y
Y
10/03/2016
AMENDMENT 1 FORM
CREATED
10/04/2016
AMENDMENT 1 FORM
SUBMITTED
Y
10/14/2016
AMENDMENT 1 FORM
REVIEWER(S) ASSIGNED
11/04/2016
AMENDMENT 1 FORM
REVIEWER(S) ASSIGNED
11/11/2016
AMENDMENT 1 FORM
MOVED
11/11/2016
AMENDMENT 1 FORM
APPROVED
Y
Y
11/11/2016
AMENDMENT 2 FORM
CREATED
11/11/2016
AMENDMENT 2 FORM
SUBMITTED
Y
11/11/2016
AMENDMENT 2 FORM
APPROVED
Y
Y
02/22/2017
AMENDMENT 3 FORM
CREATED
02/22/2017
AMENDMENT 3 FORM
SUBMITTED
Y
02/23/2017
AMENDMENT 3 FORM
REVIEWER(S) ASSIGNED
03/07/2017
AMENDMENT 3 FORM
APPROVED
Y
Y
05/12/2017
AMENDMENT 4 FORM
CREATED
05/15/2017
AMENDMENT 4 FORM
SUBMITTED
Y
05/16/2017
AMENDMENT 4 FORM
REVIEWER(S) ASSIGNED
05/18/2017
AMENDMENT 4 FORM
MOVED
05/18/2017
AMENDMENT 4 FORM
APPROVED
Y
Y
06/06/2017
CONTINUING REVIEW 1
FORM CREATED
06/06/2017
CONTINUING REVIEW 1
FORM SUBMITTED
Y
06/09/2017
CONTINUING REVIEW 1
FORM REVIEWER(S)
ASSIGNED
06/19/2017
CONTINUING REVIEW 1
FORM APPROVED
Y
Y
05/30/2018
FINAL FORM CREATED
05/30/2018
FINAL FORM SUBMITTED
Y
05/30/2018
FINAL FORM APPROVED
Y
N
05/30/2018
CLOSED

 
 
 
 
 
Page 1 of 6 Participant’s initials _______ Date _______  
Version 12May2017 
 
 
CSU#: 16-6685HH 
APPROVED:  6/15/2017* EXPIRES: 6/14/2018 
Consent to Participate in a Research Study 
Colorado State University 
 
TITLE OF STUDY: Medical marijuana and its effects on motor function in people 
with Multiple Sclerosis: An observational case-control study. 
 
 
PRINCIPAL INVESTIGATORS:   
The principal investigator is a researcher in the Department of Health and Exercise 
Science at Colorado State University: 
 
Thorsten Rudroff, Ph.D., FACSM  
 
 
 
 
Thorsten.Rudroff@ColoState.EDU  
 
 
 
970-491-8655 
 
 
 
 
 
 
 
 
 
WHY AM I BEING INVITED TO TAKE PART IN THIS RESEARCH?  
You are an adult aged between 30 and 60 years of age, and you were diagnosed with 
Multiple Sclerosis. 
 
WHO IS DOING THE STUDY?  
Dr. Rudroff and the Integrative Neurophysiology Laboratory students/research staff. 
 
WHAT IS THE PURPOSE OF THIS STUDY? 
The purpose of this study is to determine possible benefits and consequences 
associated with medical marijuana use for the management of symptoms related to a 
diagnosis of Multiple Sclerosis.  
 
WHERE IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST?  
The study will take place in the Integrative Neurophysiology Laboratory in the 
Department of Health and Exercise Science, on the Colorado State University campus. 
The study will run for approximately 12 months. You will take part in the study for 
approximately a total of 8 hours over the span of three weeks. 
 
WHAT WILL I BE ASKED TO DO?  
You will be asked to participate in two sessions on two different days: 
 
Visit 1 
Your first visit will include the following procedures and tests: 
- 
Urinalysis: We will ask you to provide a urine sample for the confirmation of your 
research group assignment. 
- 
Questionnaires: You will be asked to complete a series of questionnaires to 
determine your fatigue levels, perceived risk of falling, mood, and quality of life.   
- 
Resting Metabolic Rate: You will lay comfortably on a bed while we capture the 
air you are breathing out. Will analysis this air to determine how many calories 

 
 
 
 
 
Page 2 of 6 Participant’s initials _______ Date _______  
Version 12May2017 
 
 
CSU#: 16-6685HH 
APPROVED:  6/15/2017* EXPIRES: 6/14/2018 
you typically burn throughout the day and whether the carbs, proteins, or fats are 
your primary sources for energy generation.  
- 
Handgrip Strength: We will measure your maximal handgrip strength using a 
device which you have to squeeze alternately with your left and right hand up to 
five times.  
- 
Physical Activity: At the end of the first session, you will be introduced to the 
ActiGraph device, which will measure physical activity.  You will be asked to wear 
this device on your waist for a period of seven days (five week days and two 
weekend days). You can remove the ActiGraph at night.  You will be asked to 
return the ActiGraph at your second experimental session, which will be at least 
seven days after the first session.  Furthermore, you will receive a log to track 
their wear time.   
 
This visit will last approximately 120-180 minutes. 
 
Visit 2 
Your second visit will consist of the following tests: 
- 
MS Functional Composite: This is a series of 3 tests. The first test consists of you 
walking 25 feet as quickly and safely as possible, 2 times. The next test involves 
you placing 9 plastic pegs into a square grid of holes and removing them. The 
last test will have you add (+) a series of numbers spoken on a computer. 
- 
Balance test: In this test you will stand on a platform with your feet next to each 
other. You will stand quietly for 30 seconds in 4 different conditions: eyes open, 
eyes closed, eyes open on a foam pad, and eyes closed on a foam pad.  
- 
Leg Strength: The maximal strength of each leg will be measured by having you 
perform a series of maximal effort knee extension, knee flexion, plantar/dorsi-
flexion trials.  This will be performed one leg at a time up to five times.  
- 
6 minute walk test: The object of this test is to walk as far as possible for 6 
minutes. You will walk back and forth in a hallway around cones, and are 
permitted to slow down, to stop, and to rest as necessary. You may lean against 
the wall while resting, but resume walking as soon as you are able. 
 
This second visit will last approximately 120-180 minutes. 
 
Visit 3 
Your third visit will consist of the following tests: 
- 
Force Steadiness: For this test you will produce a submaximal force, 5%, 25% 
and 50% of your maximum strength, of your thigh muscles and hold for a period 
of 20 seconds. During this time we will place 4 stickers on your muscles 
designed to measure the electrical activity of your muscles while they are 
contracting.  
- 
Timed-Up-and-Go: For this test we will record the time it takes you to rise from a 
chair, walk 3 meters, and return to the position you started in. 
 
This third visit will last approximately 120-180 minutes. 

 
 
 
 
 
Page 3 of 6 Participant’s initials _______ Date _______  
Version 12May2017 
 
 
CSU#: 16-6685HH 
APPROVED:  6/15/2017* EXPIRES: 6/14/2018 
 
 
ARE THERE REASONS WHY I SHOULD NOT TAKE PART IN THIS STUDY? 
You should not take part in this study if: 
 
• A relapse of disease symptoms in the last 60 days 
• A condition unrelated to MS that would exacerbate fatigue, such as 
anemia, hypothyroidism, shiftwork-related fatigue, B12 deficiency, 
major sleep disorder, or major depressive disorder 
• Medical diagnosis or condition that  makes participating in exercise 
training dangerous, such as major renal, pulmonary, hepatic, cardiac, 
gastrointestinal, HIV, cancer (other than treated basal cell cancer), other 
neurological disorders, or pregnancy 
• History of heart attack or current diagnosis of cardiovascular disease 
• History of seizure disorders (or on medications known to 
lower seizure threshold), hydrocephalus (buildup of fluid in 
the brain), or diabetes 
• Alcohol dependence or abuse (>2 drinks/day), or present history 
(last six months) of drug abuse 
• History of significant traumatic brain injury or hydrocephalus 
• Pregnancy 
• Recent hospitalization (within the last 3 months) or enforced bed   
   rest/sedentary state. 
 
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS?  
It is not possible to identify all potential risks in research procedures, but the 
researcher(s) have taken reasonable safeguards to minimize any known and potential, 
but unknown, risks. 
 
 
Risks of Performing Motor Tasks 
 
Generally, the procedures outlined for measuring force and muscle activity during the 
motor tasks are safe.  Nevertheless, there is potential for injury (muscle strain), resulting 
from the maximal contractions.  There is a 0.01% chance of death (in people who have 
heart problems), a 0.02% risk of cardiac arrhythmias that would require you to go the 
hospital (in people with heart problems), and a risk of an increase or decrease in blood 
pressure. 
 
All contractions are voluntary and you can stop immediately if they experience any slight 
pain or discomfort.  Following participation, you may experience some muscle soreness.  
Muscle soreness tends to be more common for individuals who have not exercised 
recently.  Other risk factors may include increased feelings of anxiety and/or stress 
induced by the experiment, which can lead to an increase in heart rate and blood 
pressure.  The electrodes that will be used to measure muscle activity could potentially 

 
 
 
 
 
Page 4 of 6 Participant’s initials _______ Date _______  
Version 12May2017 
 
 
CSU#: 16-6685HH 
APPROVED:  6/15/2017* EXPIRES: 6/14/2018 
cause skin irritation after removal.  Furthermore, your skin will need to be shaved prior 
to placing the electrodes, which can also cause irritation. 
 
General Risk 
 
Even though the risk is minimal, there is a risk for breach of confidentiality.  Your data 
will be coded to prevent any link to your identity, and any identifying material will be 
locked in a secure filing cabinet.  Furthermore, the potential physical risks of 
participating in the proposed experiments are reasonably small.  The motor 
performance tasks have been used previously by the members of the investigative team 
without complication.   
 
ARE THERE ANY BENEFITS FROM TAKING PART IN THIS STUDY?  
There may be no direct benefit to you associated with this research. This study is 
designed for the researcher to learn more about the effects of medical marijuana use for 
symptom management related to your diagnosis of Multiple Sclerosis.  This study is not 
designed to treat any illness or to improve your health specifically.   
 
DO I HAVE TO TAKE PART IN THE STUDY?  
Your participation in this research is voluntary.  If you decide to participate in the study, 
you may withdraw your consent and stop participating at any time. 
 
WHAT WILL IT COST ME TO PARTICIPATE?  
Other than transport to and from the lab, your participation should incur no costs. 
 
WHO WILL SEE THE INFORMATION THAT I GIVE?  
We will keep private all research records that identify you, to the extent allowed by law.  
Your information will be combined with information from other people taking part in the 
study.  When we write about the study to share with other researchers, we will write 
about the combined information we have gathered.  You will not be identified in these 
written materials.  We may publish the results of this study; however, we will keep your 
name and other identifying information private. 
 
We will make every effort to prevent anyone who is not on the research team from 
knowing that you gave us information, or what that information is.  For example, your 
name will be kept separate from your research records and these two things will be 
stored in different places under lock and key.  You should know, however, that there are 
some circumstances in which we may have to show your information to other people.  
We may be asked to share the research files with the CSU Institutional Review Board 
ethics committee for auditing purposes, if necessary. 
 
CAN MY TAKING PART IN THE STUDY END EARLY?  
If you fail to show up to your visits you may be removed from the study. 
 
WILL I RECEIVE ANY COMPENSATION FOR TAKING PART IN THIS STUDY? 

 
 
 
 
 
Page 5 of 6 Participant’s initials _______ Date _______  
Version 12May2017 
 
 
CSU#: 16-6685HH 
APPROVED:  6/15/2017* EXPIRES: 6/14/2018 
Yes, you will receive $20, $25, and $30 pre-paid Visa gift cards after the 1st, 2nd, and 3rd 
visits, respectively. 
 
WHAT HAPPENS IF I AM INJURED BECAUSE OF THE RESEARCH?  
The Colorado Governmental Immunity Act determines and may limit Colorado State 
University's legal responsibility if an injury happens because of this study.  Claims 
against the University must be filed within 180 days of the injury. The research team will 
not cover any injury resulting in this study. You and/or your health insurance will be 
responsible for paying for any study-related injury. 
 
FUTURE STUDIES: 
Would you like to be contacted for future studies that you may be eligible for? Please 
initial:   
 
 
Yes 
 
 
 
No 
 
WHAT IF I HAVE QUESTIONS?       
Before you decide whether to accept this invitation to take part in the study, please ask 
any questions that might come to mind now.  Later, if you have questions about the 
study, you can contact the investigator, Dr. Thorsten Rudroff, via phone 970-491-8655 or 
email: Thorsten.rudroff@colostate.edu.  If you have any questions about your rights as a 
volunteer in this research, contact the CSU IRB at:  RICRO_IRB@mail.colostate.edu; 
970-491-1553. We will give you a copy of this consent form to take with you. 
 
WHAT ELSE DO I NEED TO KNOW? 
 
A description of this clinical trial will be available on http://www.ClinicialTrials.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 
anytime. 
 
 
 
Your signature acknowledges that you have read the information stated and willingly sign 
this consent form.  Your signature also acknowledges that you have received, on the 
date signed, a copy of this document containing    5     pages. 
 
_________________________________________ 
_____________________ 
Signature of person agreeing to take part in the study  
 
 
Date 
 
_________________________________________ 
_____________________ 
Printed name of person agreeing to take part in the study  
Time of Day 
 
_______________________________________  
_____________________ 
Name of person providing information to participant 
 
 
 
Date 
 
_________________________________________    

 
 
 
 
 
Page 6 of 6 Participant’s initials _______ Date _______  
Version 12May2017 
 
 
CSU#: 16-6685HH 
APPROVED:  6/15/2017* EXPIRES: 6/14/2018 
Signature of Research Staff 

 
 
 
 
 
Page 1 of 5 Participant’s initials _______ Date _______  
Version 12May2017 
CSU#: 16-6685HH 
APPROVED: 6/15/2017 * EXPIRES: 6/14/2018 
Consent to Participate in a Research Study 
Colorado State University 
 
TITLE OF STUDY: Medical marijuana and its effects on motor function in people 
with Multiple Sclerosis: An observational case-control study. 
 
 
PRINCIPAL INVESTIGATORS:   
The principal investigator is a researcher in the Department of Health and Exercise 
Science at Colorado State University: 
 
Thorsten Rudroff, Ph.D., FACSM  
 
 
 
 
Thorsten.Rudroff@ColoState.EDU  
 
 
 
970-491-8655 
 
 
 
 
 
 
 
 
 
WHY AM I BEING INVITED TO TAKE PART IN THIS RESEARCH?  
You are an adult aged between 30 and 60 years of age, and you were diagnosed with 
Multiple Sclerosis. 
 
WHO IS DOING THE STUDY?  
Dr. Rudroff and the Integrative Neurophysiology Laboratory students/research staff. 
 
WHAT IS THE PURPOSE OF THIS STUDY? 
The purpose of this study is to determine possible benefits and consequences 
associated with medical marijuana use for the management of symptoms related to a 
diagnosis of Multiple Sclerosis.  
 
WHERE IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST?  
The study will take place in the Integrative Neurophysiology Laboratory in the 
Department of Health and Exercise Science, on the Colorado State University campus. 
The study will run for approximately 12 months. You will take part in the study for 
approximately a total of 8 hours over the span of three weeks. 
 
WHAT WILL I BE ASKED TO DO?  
You will be asked to participate in two sessions on two different days: 
 
Visit 1 
Your first visit will include the following procedures and tests: 
- 
Urinalysis: We will ask you to provide a urine sample for the confirmation of your 
research group assignment. 
- 
Questionnaires: You will be asked to complete a series of questionnaires to 
determine your fatigue levels, perceived risk of falling, mood, and quality of life.   
- 
Resting Metabolic Rate: You will lay comfortably on a bed while we capture the 
air you are breathing out. Will analysis this air to determine how many calories 
you typically burn throughout the day and whether the carbs, proteins, or fats are 
your primary sources for energy generation.  

 
 
 
 
 
Page 2 of 5 Participant’s initials _______ Date _______  
Version 12May2017 
CSU#: 16-6685HH 
APPROVED: 6/15/2017 * EXPIRES: 6/14/2018 
- 
Handgrip Strength: We will measure your maximal handgrip strength using a 
device which you have to squeeze alternately with your left and right hand up to 
five times.  
- 
Medical Marijuana Use: We will give you a log to track your medical marijuana 
usage over the next 7 days.  
- 
Physical Activity: At the end of the first session, you will be introduced to the 
ActiGraph device, which will measure physical activity.  You will be asked to wear 
this device on your waist for a period of seven days (five week days and two 
weekend days). You can remove the ActiGraph at night.  You will be asked to 
return the ActiGraph at your second experimental session, which will be at least 
seven days after the first session.  Furthermore, you will receive a log to track 
their wear time.   
 
This visit will last approximately 120-180 minutes. 
 
Visit 2 
Your second visit will consist of the following tests: 
- 
MS Functional Composite: This is a series of 3 tests. The first test consists of you 
walking 25 feet as quickly and safely as possible, 2 times. The next test involves 
you placing 9 plastic pegs into a square grid of holes and removing them. The 
last test will have you add (+) a series of numbers spoken on a computer. 
- 
Balance test. In this test you will stand on a platform with your feet next to each 
other. You will stand quietly for 30 seconds in 4 different conditions: eyes open, 
eyes closed, eyes open on a foam pad, and eyes closed on a foam pad. 
- 
Leg Strength: The maximal strength of each leg will be measured by having you 
perform a series of maximal effort knee extension, knee flexion, plantar/dorsi-
flexion trials.  This will be performed one leg at a time up to five times.  
- 
6 minute walk test: The object of this test is to walk as far as possible for 6 
minutes. You will walk back and forth in a hallway around cones, and are 
permitted to slow down, to stop, and to rest as necessary. You may lean against 
the wall while resting, but resume walking as soon as you are able. 
 
This second visit will last approximately 120-180 minutes. 
 
 
 
Visit 3 
Your third visit will consist of the following tests: 
- 
Force Steadiness: For this test you will produce a submaximal force, 5%, 25% 
and 50% of your maximum strength, of your thigh muscles and hold for a period 
of 20 seconds. During this time we will place 4 stickers on your muscles 
designed to measure the electrical activity of your muscles while they are 
contracting.  
- 
Timed-Up-and-Go: For this test we will record the time it takes you to rise from a 
chair, walk 3 meters, and return to the position you started in. 
 

 
 
 
 
 
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This third visit will last approximately 120-180 minutes. 
 
ARE THERE REASONS WHY I SHOULD NOT TAKE PART IN THIS STUDY? 
You should not take part in this study if: 
 
• A relapse of disease symptoms in the last 60 days 
• A condition unrelated to MS that would exacerbate fatigue, such as 
anemia, hypothyroidism, shiftwork-related fatigue, B12 deficiency, 
major sleep disorder, or major depressive disorder 
• Medical diagnosis or condition that  makes participating in exercise 
training dangerous, such as major renal, pulmonary, hepatic, cardiac, 
gastrointestinal, HIV, cancer (other than treated basal cell cancer), other 
neurological disorders, or pregnancy 
• History of heart attack or current diagnosis of cardiovascular disease 
• History of seizure disorders (or on medications known to 
lower seizure threshold), hydrocephalus (buildup of fluid in 
the brain), or diabetes 
• Alcohol dependence or abuse (>2 drinks/day), or present history 
(last six months) of drug abuse 
• History of significant traumatic brain injury or hydrocephalus 
• Pregnancy 
• Recent hospitalization (within the last 3 months) or enforced bed   
   rest/sedentary state. 
 
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS?  
It is not possible to identify all potential risks in research procedures, but the 
researcher(s) have taken reasonable safeguards to minimize any known and potential, 
but unknown, risks. 
 
Risks of Performing Motor Tasks 
 
Generally, the procedures outlined for measuring force and muscle activity during the 
motor tasks are safe.  Nevertheless, there is potential for injury (muscle strain), resulting 
from the maximal contractions.  There is a 0.01% chance of death (in people who have 
heart problems), a 0.02% risk of cardiac arrhythmias that would require you to go the 
hospital (in people with heart problems), and a risk of an increase or decrease in blood 
pressure. 
 
All contractions are voluntary and you can stop immediately if they experience any slight 
pain or discomfort.  Following participation, you may experience some muscle soreness.  
Muscle soreness tends to be more common for individuals who have not exercised 
recently.  Other risk factors may include increased feelings of anxiety and/or stress 
induced by the experiment, which can lead to an increase in heart rate and blood 
pressure.  The electrodes that will be used to measure muscle activity could potentially 
cause skin irritation after removal.  Furthermore, your skin will need to be shaved prior 
to placing the electrodes, which can also cause irritation. 

 
 
 
 
 
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General Risk 
 
Even though the risk is minimal, there is a risk for breach of confidentiality.  Your data 
will be coded to prevent any link to your identity, and any identifying material will be 
locked in a secure filing cabinet.  Furthermore, the potential physical risks of 
participating in the proposed experiments are reasonably small.  The motor 
performance tasks have been used previously by the members of the investigative team 
without complication.   
 
ARE THERE ANY BENEFITS FROM TAKING PART IN THIS STUDY?  
There may be no direct benefit to you associated with this research. This study is 
designed for the researcher to learn more about the effects of medical marijuana use for 
symptom management related to your diagnosis of Multiple Sclerosis.  This study is not 
designed to treat any illness or to improve your health specifically.   
 
DO I HAVE TO TAKE PART IN THE STUDY?  
Your participation in this research is voluntary.  If you decide to participate in the study, 
you may withdraw your consent and stop participating at any time. 
 
WHAT WILL IT COST ME TO PARTICIPATE?  
Other than transport to and from the lab, your participation should incur no costs. 
 
WHO WILL SEE THE INFORMATION THAT I GIVE?  
We will keep private all research records that identify you, to the extent allowed by law.  
Your information will be combined with information from other people taking part in the 
study.  When we write about the study to share with other researchers, we will write 
about the combined information we have gathered.  You will not be identified in these 
written materials.  We may publish the results of this study; however, we will keep your 
name and other identifying information private. 
 
We will make every effort to prevent anyone who is not on the research team from 
knowing that you gave us information, or what that information is.  For example, your 
name will be kept separate from your research records and these two things will be 
stored in different places under lock and key.  You should know, however, that there are 
some circumstances in which we may have to show your information to other people.  
We may be asked to share the research files with the CSU Institutional Review Board 
ethics committee for auditing purposes, if necessary. 
 
 
CAN MY TAKING PART IN THE STUDY END EARLY?  
If you fail to show up to your visits you may be removed from the study. 
 
WILL I RECEIVE ANY COMPENSATION FOR TAKING PART IN THIS STUDY? 
Yes, you will receive $20, $25, and $30 pre-paid Visa gift cards after the 1st, 2nd, and 3rd 
visits, respectively. 

 
 
 
 
 
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WHAT HAPPENS IF I AM INJURED BECAUSE OF THE RESEARCH?  
The Colorado Governmental Immunity Act determines and may limit Colorado State 
University's legal responsibility if an injury happens because of this study.  Claims 
against the University must be filed within 180 days of the injury. The research team will 
not cover any injury resulting in this study. You and/or your health insurance will be 
responsible for paying for any study-related injury. 
 
FUTURE STUDIES: 
Would you like to be contacted for future studies that you may be eligible for? Please 
initial:   
 
 
Yes 
 
 
 
No 
 
WHAT IF I HAVE QUESTIONS?       
Before you decide whether to accept this invitation to take part in the study, please ask 
any questions that might come to mind now.  Later, if you have questions about the 
study, you can contact the investigator, Dr. Thorsten Rudroff, via phone 970-491-8655 or 
email: Thorsten.rudroff@colostate.edu.  If you have any questions about your rights as a 
volunteer in this research, contact the CSU IRB at:  RICRO_IRB@mail.colostate.edu; 
970-491-1553. We will give you a copy of this consent form to take with you. 
 
WHAT ELSE DO I NEED TO KNOW? 
 
A description of this clinical trial will be available on http://www.ClinicialTrials.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 
anytime. 
 
 
 
Your signature acknowledges that you have read the information stated and willingly sign 
this consent form.  Your signature also acknowledges that you have received, on the 
date signed, a copy of this document containing    5     pages. 
 
_________________________________________ 
_____________________ 
Signature of person agreeing to take part in the study  
 
 
Date 
 
_________________________________________ 
_____________________ 
Printed name of person agreeing to take part in the study  
Time of Day 
 
_______________________________________  
_____________________ 
Name of person providing information to participant 
 
 
 
Date 
 
_________________________________________    
Signature of Research Staff 

Statistical Analysis 
            All data are reported as Mean (Standard Deviation) unless otherwise noted. Pearson’s correlations 
were calculated between demographic variables (age, height, weight, BMI, disease duration) and whole 
brain SUV to identify possible covariates for the SPM analysis. Significant factors were individually 
tested as covariates during SPM analysis.  
 
Demographic, clinical, and extracted regional SUV variables were compared between the two 
groups using unpaired student’s t-tests. If a clinical variable differed between the two groups a Pearson’s 
correlation was performed with it and regional SUVs. Cohen’s D measures of effect size were calculated 
for the regional SUVs. Analysis was performed using IBM SPSS Statistics for Windows version 24 (IBM 
Corp., NY, USA) with alpha set to 0.05.