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

NCT02898974 | Completed Results

• 1 other identifier: 16-6685HH
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Regular Medical Marijuana users

People with MS that are regular Medical Marijuana users

Behavioral: Medical Marijuana

Non Users of Medical Marijuana

People with MS that are non users of Medical Marijuana

Interventions

Medical Marijuana BEHAVIORAL

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

Regular Medical Marijuana users

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adults diagnosed with Multiple Sclerosis.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colorado State University: lead
• William R. Shaffer, M.D.: collaborator

Study Sites (1)

Department of Health and Exercise Science

Fort Collins, Colorado, 80523, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Manager of Research Operations
• Organization: Colorado State University

Laurie.Biela@colostate.edu

9704912242

Study Officials

• Thorsten Rudroff, Ph.D.

  Colorado State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 13, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)