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| Name | Class |
|---|---|
| Celgene | INDUSTRY |
| Hackensack Meridian Health | OTHER |
| St. Barnabas Medical Center | OTHER |
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The purpose of this research study is to investigate the effectiveness of MS Disease modifying medications on cognitive fatigue in persons with relapsing remitting multiple sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.
The researchers aim is to investigate the effects of disease modifying treatments on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with Multiple Sclerosis (MS). The researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task, and also on how cognitive fatigue changes as a function of duration of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS Zeposia | Individuals with MS who will begin taking Zeposia as part of standard care. |
| |
| MS High dose efficacy medication | Individuals with MS who will begin taking high dose efficacy oral medication as part of standard of care. | ||
| Healthy Control | Healthy controls, all of whom will be matched on age, education and gender to the MS groups. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zeposia | Drug | Participants with MS will be divided into two treatment groups: those who will begin to take Zeposia, and those who plan to be begin treatment with high dose oral efficacy medication. The HC group will be free of neurological disease or injury and will be matched to the MS groups for age, gender, and education. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain activation (BOLD signal) | A change in brain activation as measured with functional magnetic resonance imaging through blood oxygen level dependent signal will be measured in association with cognitive fatigue (as measured by the Visual Analogue scale during performance of the modified Symbol Digit Modality and Modified Fatigue Impact Scale). | Measured for change at 3 time points (before, six months and 12 months after intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Onset | A change in the speed with which modified Symbol Digit Modality task (a cognitively demanding task) induces fatigue in MS (as measured by the Visual Analogue scale and Modified Fatigue Impact Scale). | Measured for change at 3 time points (before, six months and 12 months after intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with Relapsing Remitting Multiple Sclerosis and Healthy Controls
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nancy Moore | Contact | 973-324-8450 | nbmoore@kesslerfoundation.org | |
| Amanda PraSisto | Contact | 973-324-3507 | aprasisto@kesslerfoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| John DeLuca, PhD | Kessler Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | Recruiting | West Orange | New Jersey | 07052 | United States |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000607776 | ozanimod |
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| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |