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Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02898974
Recruitment Status : Completed
First Posted : September 13, 2016
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
William R. Shaffer, M.D.
Information provided by (Responsible Party):
Thorsten Rudroff, Colorado State University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Sclerosis Behavioral: Medical Marijuana

Detailed Description:
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).
Study Design
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Study Type : Observational
Actual Enrollment : 22 participants
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
Study Start Date : September 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Fatigue [ Time Frame: Through study completion, an average of 6 months. ]
    Strength decline during fatiguing muscle contraction measured with force transducer

  2. Muscle Strength [ Time Frame: Through study completion, an average of 6 months. ]
    Maximal muscle strength measured with force transducer

  3. Postural Stability [ Time Frame: Through study completion, an average of 6 months. ]
    Timed up and go


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults diagnosed with Multiple Sclerosis.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898974


Locations
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United States, Colorado
Department of Health and Exercise Science
Fort Collins, Colorado, United States, 80523
Sponsors and Collaborators
Colorado State University
William R. Shaffer, M.D.
Investigators
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Principal Investigator: Thorsten Rudroff, Ph.D. Colorado State University
  Study Documents (Full-Text)

Documents provided by Thorsten Rudroff, Colorado State University:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] June 19, 2017

More Information
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Responsible Party: Thorsten Rudroff, Assistant Professor, Colorado State University
ClinicalTrials.gov Identifier: NCT02898974    
Other Study ID Numbers: 16-6685HH
First Posted: September 13, 2016    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases