Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis (MS)



Status:Recruiting
Conditions:Cognitive Studies, Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 45
Updated:10/31/2018
Start Date:July 1, 2018
End Date:June 16, 2020
Contact:Kathleen Sherman
Email:kathleen.cherman@nyumc.org
Phone:929 455 5125

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Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis

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.


Inclusion Criteria:

- Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (PHI) in
accordance with national and local subject privacy regulations.

- Male and Female subjects between 18 and 45 years

- WRAT-4 Reading [127] standard score of 85 to 115 For MS Participants

- Definite diagnosis of RRMS [128]

- EDSS of 0 to 6.0

- Adequate vision (20/50 or better) and hearing, based on neurological exam

- Eligible for initiation of Tecfidera therapy, with no contraindications

- At baseline visit, concurrent medications to be kept constant over three months prior
to data collection visits

- No relapse or steroids in previous month

- Able to undergo neuroimaging data collection procedures.

Exclusion Criteria:

- Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (PHI) in
accordance with national and local subject privacy regulations.

- Male and Female subjects between 18 and 45 years

- WRAT-4 Reading [127] standard score of 85 to 115 For MS Participants

- Definite diagnosis of RRMS [128]

- EDSS of 0 to 6.0

- Adequate vision (20/50 or better) and hearing, based on neurological exam

- Eligible for initiation of Tecfidera therapy, with no contraindications

- At baseline visit, concurrent medications to be kept constant over three months prior
to data collection visits

- No relapse or steroids in previous month

- Able to undergo neuroimaging data collection procedures.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Leigh Charvet, MD
Phone: 929-455-5125
New York University School of Medicine NYU School of Medicine has a proud history that...
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