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

NCT ID: NCT02898974

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-10-31

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.

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).

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Regular Medical Marijuana users

People with MS that are regular Medical Marijuana users

Medical Marijuana

Intervention Type: BEHAVIORAL

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

No interventions assigned to this group

Interventions

Medical Marijuana

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William R. Shaffer, M.D.

UNKNOWN

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Thorsten Rudroff

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thorsten Rudroff, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

Department of Health and Exercise Science

Fort Collins, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

16-6685HH

Identifier Type: -

Identifier Source: org_study_id