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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Department of Health and Exercise Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults diagnosed with Multiple Sclerosis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Strength decline during fatiguing muscle contraction measured with force transducer	Through study completion, an average of 6 months.
Muscle Strength	Maximal muscle strength measured with force transducer	Through study completion, an average of 6 months.
Postural Stability	Timed up and go	Through study completion, an average of 6 months.

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: William R. Shaffer, M.D.
• Investigators: Principal Investigator: Thorsten Rudroff, Ph.D., Colorado State University

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 16-6685HH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO