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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 : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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)

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 : June 16, 2020
Estimated Study Completion Date : June 16, 2020

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.



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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:

  • 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.

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
Contact: Kathleen Sherman 929 455 5125 kathleen.cherman@nyumc.org

Locations
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
New York University School of Medicine
Investigators
Principal Investigator: Leigh Charvet New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03723356     History of Changes
Other Study ID Numbers: 17-00238
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple 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