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

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ClinicalTrials.gov Identifier: NCT03723356
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Sclerosis Cognition Disorders Diagnostic Test: Siemens Biograph mMR (molecular MR) Diagnostic Test: fMRI Diagnostic Test: Diffusion Spectrum Imaging (DSI)

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 13, 2021
Estimated Study Completion Date : December 13, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MS Patients
Definite diagnosis of RRMS
Diagnostic Test: 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,

Diagnostic Test: 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.

Diagnostic Test: 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
Diagnostic Test: 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,

Diagnostic Test: 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.

Diagnostic Test: 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




Primary Outcome Measures :
  1. intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT) [ Time Frame: Baseline ]
    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.

  2. intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT) [ Time Frame: 3 Months ]
    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. intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT) [ Time Frame: 6 Months ]
    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.

  4. intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT) [ Time Frame: 9 Months ]
    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.

  5. intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT) [ Time Frame: 12 Months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. 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.
  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:

  1. Unable or unwilling to provide informed consent.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723356


Contacts
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Contact: Matthew Lustberg, MA 9294555090 Matthew.Lustberg@nyulangone.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Kathleen Sherman, MD    929-455-5125    kai.sherman@nyumc.org   
Principal Investigator: Leigh Charvet, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Leigh Charvet NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03723356    
Other Study ID Numbers: 17-00238
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Cognition Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurocognitive Disorders
Mental Disorders