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due to low enrollment
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Multiple sclerosis (MS) is the most common progressive neurologic disorder to occur in adults of working-age. Despite longstanding recognition of cognitive impairment as a symptom of MS, two obstacles in measurement have limited understanding its biological basis, and therefore identifying targeted options for management. First is the absence of a sensitive and precise measure of cognitive impairment. Second is the absence of an index of disease status linked to brain pathophysiology and cognitive performance. This project overcomes both obstacles to link cognitive impairment to MS disease biomarkers. The absence of a sensitive and precise measure of cognitive impairment, along with the absence of an index of disease status linked to brain pathophysiology and cognitive performance, limits the understanding of the biological basis for multiple sclerosis (MS). This project overcomes both obstacles to link cognitive function to MS disease biomarkers, and provides preliminary evaluation of a disease modifying therapy (Tecfidera) for preserving cognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS Patients | Definite diagnosis of RRMS |
| |
| Healthy Controls | gender aged match healthy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siemens Biograph mMR (molecular MR) | Diagnostic Test | 5mCi of the radiotracer FDG administered intravenously as a bolus over 30s. After injection, emission data will be collected for 60 min, |
| Measure | Description | Time Frame |
|---|---|---|
| intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT) | Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen. | Baseline |
| intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT) | Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen. | 3 Months |
| intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT) | Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen. | 6 Months |
| intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT) | Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen. | 9 Months |
| intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT) | Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
Unable or unwilling to provide informed consent.
Beck Depression Inventory-Fast Screen (BDI-FS) [129, 130] score of 4 or more
Current alcohol or other substance use disorder
Primary psychiatric disorder that would adversely influence ability to participate
Other neurological condition associated with cognitive impairment (e.g., epilepsy, brain injury)
Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
Learned English language after 12 years of age
For low absolute low lymphocyte count (ALC), USPI guidance will be utilized.
For MS participants:
Lemtrada, Cladribine, Mitoxantrone
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20 MS participants and 10 healthy controls. However, the data analysis is planned for 15 MS participants and 10 healthy control participants. It is expected that 15 MS subjects and 10 healthy controls will complete 12 months.
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Charvet | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D003072 | Cognition Disorders |
| 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 |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| fMRI | Diagnostic Test | High-resolution T1-weighted structural image will be acquired using an MP2RAGE sequence. Subject will beasked to look at the cross hair on a screen andnot fixate on any one thought. |
|
| Diffusion Spectrum Imaging (DSI) | Diagnostic Test | DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |