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| Name | Class |
|---|---|
| St. Barnabas Medical Center | OTHER |
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The purpose of this research study is to investigate the effectiveness of Tysabri 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 Tysabri on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with RRMS. 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 |
|---|---|---|---|
| Group 1: Multiple Sclerosis | Individuals with RRMS who are going to be starting Tysabri as determined by Neurologist as part of clinical care. Intervention: Drug: Tysabri |
| |
| Group 2: Healthy Controls | Healthy individuals who are age, gender and education matched to the MS group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tysabri | Drug | Participants with RRMS who are planning to begin treatment with Tysabri will be compared to a group of healthy individuals who are matched 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 Task and Modified Fatigue Impact Scale). | Measured by change between 2 time points (baseline and six months after intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue onset (SDMT) | 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) | Measured by change between 2 time points (baseline and six months after intervention) |
| Fatigue onset |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals diagnosed with Relapsing-Remitting Multiple Sclerosis and Healthy Volunteers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nancy Moore, M.A. | Contact | 19733248450 | nbmoore@kesslerfoundation.org | |
| Angela Smith, M.A. | Contact | 19733248448 | asmith@kesslerfoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| John DeLuca, Ph.D. | 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 |
| 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 |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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 Modified Fatigue Impact Scale) |
| Measured by change between 2 time points (baseline and six months after intervention) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |