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Verified September 2016 by Colorado State University



William R. Shaffer, M.D.

Information provided by (Responsible Party):

Thorsten Rudroff, Colorado State University

ClinicalTrials.gov Identifier:


First received: September 6, 2016

Last updated: September 8, 2016

Last verified: September 2016

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 the investigators plan to objectively measure multiple domains of motor function, such as: fatigue, strength, and walking ability. No marijuana will be brought on to campus or given to participants.

Multiple Sclerosis Behavioral: Medical Marijuana

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis: An Observational Case-control Study

Primary Outcome Measures:

  • Fatigue [ Time Frame: Through study completion, an average of 6 months. ] [ Designated as safety issue: No ]

    Strength decline during fatiguing muscle contraction measured with force transducer

  • Muscle Strength [ Time Frame: Through study completion, an average of 6 months. ] [ Designated as safety issue: No ]

    Maximal muscle strength measured with force transducer

  • Postural Stability [ Time Frame: Through study completion, an average of 6 months. ] [ Designated as safety issue: No ]

    Measured with force plates

Estimated Enrollment: 32
Study Start Date: September 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Regular Medical Marijuana users

People with MS that are regular Medical Marijuana users

Behavioral: Medical Marijuana

To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design

Non Users of Medical Marijuana

People with MS that are non users of Medical Marijuana

To investigate the effects of medical marijuana usage on physical function the investigators 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).

Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

Adults diagnosed with Multiple Sclerosis.

Inclusion Criteria:

  • Medically diagnosed with MS,
  • 30-60 years of age,
  • Moderate disability (Patient Determined Disease Steps score 2-6).

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,
  • Inability to understand/sign informed consent.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02898974

Department of Health and Exercise Science
Fort Collins, Colorado, United States, 80523
Contact: Laurie M Biela, BS    970-491-2242    Laurie.Biela@nullcolostate.edu   

Colorado State University

William R. Shaffer, M.D.

Principal Investigator: Thorsten Rudroff, Ph.D. Colorado State University

Additional Information:

Responsible Party: Thorsten Rudroff, Assistant Professor, Colorado State University
ClinicalTrials.gov Identifier: NCT02898974     History of Changes
Other Study ID Numbers: 16-6685HH 
Study First Received: September 6, 2016
Last Updated: September 8, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:

Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 13, 2016