Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis (MS)
NCT ID: NCT03723356
Last Updated: 2021-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
6 participants
OBSERVATIONAL
2018-07-01
2021-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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MS Patients
Definite diagnosis of RRMS
Siemens Biograph mMR (molecular MR)
5mCi of the radiotracer FDG administered intravenously as a bolus over 30s. After injection, emission data will be collected for 60 min,
fMRI
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)
DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers
Healthy Controls
gender aged match healthy
Siemens Biograph mMR (molecular MR)
5mCi of the radiotracer FDG administered intravenously as a bolus over 30s. After injection, emission data will be collected for 60 min,
fMRI
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)
DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers
Interventions
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Siemens Biograph mMR (molecular MR)
5mCi of the radiotracer FDG administered intravenously as a bolus over 30s. After injection, emission data will be collected for 60 min,
fMRI
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)
DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers
Eligibility Criteria
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Inclusion Criteria
2. Male and Female subjects between 18 and 45 years
3. WRAT-4 Reading \[127\] standard score \> 85
4. Able to undergo neuroimaging data collection procedures. For MS Participants
5. Definite diagnosis of RRMS \[128\]
6. EDSS of 0 to 6.0
7. Adequate vision as as reported by the participant (with correction if applicable)
8. Clinically prescribed Tecfidera, Tysabri or Ocrevus therapy by treating neurologist, with first dose being within 3 months + 14 days from baseline visit
9. At baseline visit, concurrent medications to be kept constant over three months prior to data collection visits
10. No relapse or steroids in previous month
Exclusion Criteria
2. Beck Depression Inventory-Fast Screen (BDI-FS) \[129, 130\] score of 4 or more
3. Current alcohol or other substance use disorder
4. Primary psychiatric disorder that would adversely influence ability to participate
5. Other neurological condition associated with cognitive impairment (e.g., epilepsy, brain injury)
6. Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
7. Learned English language after 12 years of age
8. For low absolute low lymphocyte count (ALC), USPI guidance will be utilized.
For MS participants:
9. Lemtrada, Cladribine, Mitoxantrone
18 Years
45 Years
ALL
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Leigh Charvet
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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17-00238
Identifier Type: -
Identifier Source: org_study_id
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