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| Name | Class |
|---|---|
| William R. Shaffer, M.D. | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular Medical Marijuana users | People with MS that are regular Medical Marijuana users |
| |
| Non Users of Medical Marijuana | People with MS that are non users of Medical Marijuana |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Marijuana | Behavioral | To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults diagnosed with Multiple Sclerosis.
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| Name | Affiliation | Role |
|---|---|---|
| Thorsten Rudroff, Ph.D. | Colorado State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Health and Exercise Science | Fort Collins | Colorado | 80523 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Regular Medical Marijuana Users | People with MS that are regular Medical Marijuana users Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design |
| FG001 | Non Users of Medical Marijuana | People with MS that are non users of Medical Marijuana |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Regular Medical Marijuana Users | People with MS that are regular Medical Marijuana users Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design |
| BG001 | Non Users of Medical Marijuana |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fatigue | Strength decline during fatiguing muscle contraction measured with force transducer | Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users. Matching was only possible for 16 subjects. The remaining 6 subjects were not included in the analysis. | Posted | Mean | Standard Deviation | % decline | Through study completion, an average of 6 months. |
|
Through out the study and assessed at every study visit, an average of 6 months.
Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regular Medical Marijuana Users | People with MS that are regular Medical Marijuana users Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Research Operations | Colorado State University | 9704912242 | Laurie.Biela@colostate.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 19, 2017 | Jul 24, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D064086 | Medical Marijuana |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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People with MS that are non users of Medical Marijuana |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
People with MS that are non users of Medical Marijuana |
|
|
| Primary | Muscle Strength | Maximal muscle strength measured with force transducer | Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users. | Posted | Mean | Standard Deviation | Newton | Through study completion, an average of 6 months. |
|
|
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| Primary | Postural Stability | Timed up and go | Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users. | Posted | Mean | Standard Deviation | Seconds | Through study completion, an average of 6 months. |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Non Users of Medical Marijuana | People with MS that are non users of Medical Marijuana | 0 | 9 | 0 | 9 | 0 | 9 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |