Verified September 2016 by Colorado State University
Sponsor:
Collaborator:
William R. Shaffer, M.D.
Information provided by (Responsible Party):
Thorsten Rudroff, Colorado State University
ClinicalTrials.gov Identifier:
NCT02898974
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 |
- 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.
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 |
| 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:
| Sclerosis 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