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Pathological Basis of MRI Signal Changes in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02659956
Recruitment Status : Recruiting
First Posted : January 21, 2016
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Tracking Information
First Submitted Date January 20, 2016
First Posted Date January 21, 2016
Last Update Posted Date November 28, 2019
Actual Study Start Date April 17, 2016
Estimated Primary Completion Date February 26, 2080   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 22, 2019)
Correlation among in vivo imaging, postmortem imaging, and pathological characteristics of individual areas of tissue damage ("lesions") in the brain, spinal cord, and retinas. [ Time Frame: annual visits ]
Correlation among in vivo imaging, postmortem imaging, and pathological characteristics of individual areas of tissue damage ( lesions ) in the brain, spinal cord, and retinas. Priority will be given to measures of myelination, axonal preservation, inflammation, and astrogliosis, as judged primarily by histological stains and immunohistochemistry.
Original Primary Outcome Measures
 (submitted: January 20, 2016)
Correlation among in vivo imaging, postmortem imaging, and pathological characteristics of individual areas of tissue damage ("lesions") in the brain, spinal cord, and retinas. [ Time Frame: Time of Autopsy ]
Change History Complete list of historical versions of study NCT02659956 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 20, 2016)
Correlation among in vivo imaging, postmortem imaging, and pathological characteristics of nonlesional structures in the brain, spinal cord, and retinas. [ Time Frame: Autopsy ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pathological Basis of MRI Signal Changes in Multiple Sclerosis
Official Title The Pathological Basis of MRI Signal Changes in Multiple Sclerosis: A Longitudinal In Vivo-to-Postmortem Study
Brief Summary

Background:

Multiple sclerosis (MS) is a disease that damages the central nervous system (brain and spinal cord). This leads to increased physical disability over time. The disease is lifelong once it begins. Researchers want to learn more about MS s stages and follow them until a person s death.

Objective:

To understand how the physical and clinical signs of MS relate to its changes over time.

Eligibility:

Adults age 18 or older with MS or a disease of the brain and spinal cord that may act like MS.

Design:

Participants will have a medical history and a complete neurological exam. They may have timed tests of neurological function, such as a 25-foot walk and a 9-hole peg test.

Participants will have multi-day visits about once a year.

Participants will have blood drawn.

Participants may have a brain magnetic resonance imaging (MRI) scan. They may also have an MRI of the spinal cord. They may get a contrast agent (dye) injected into a tube in an arm vein. During the MRI, participants will lie on a table that slides in and out of a metal cylinder.

Participants will have the thickness of their retina measured using optical coherence tomography. A camera on top of a table uses lasers. Participants will look through a lens and follow instructions. Eye drops may be used to dilate the pupils.

Participants will chew on a piece of sterile cotton for 1 minute to collect saliva.

Participants agree to have an autopsy at the time of their death and to donate some of their organs to research, such as the brain and spinal cord.

Detailed Description

Objective:

The goal of this protocol is to understand how the pathology of multiple sclerosis (MS) relates to its evolution over time as observed through neuroradiological, clinical, and biological data collection in vivo.

Study population:

This study will enroll up to 100 individuals with MS, targeting 50 study completers, across various ages and stages of the disease, as well as 20 appropriate disease control participants, for a total of 120 participants.

Design:

This is a longitudinal cohort study in which participants will be seen approximately annually at the NIH Clinical Center. Most visits will extend over several days. Participants will receive ongoing care by their outside clinician. They may also concurrently participate in additional research protocols at the NIH or elsewhere, and data may be shared between those protocols and the current one. At the time of death, the central nervous system (CNS) (brain, spinal cord, retinas, and cerebrospinal fluid), as well as lymph nodes and possibly other lymphoid tissue, will be harvested.

Outcome measures:

Outcome measures include data derived from magnetic resonance imaging (MRI) of the brain and spinal cord, optical coherence tomography (OCT) of the retinas, clinical examination, and disability scales; radiological and pathological examination of CNS tissue; and the correlation between in vivo and postmortem measures. Particular attention will be paid to the extent to which longitudinal in vivo changes predict postmortem findings.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary clinical
Condition Multiple Sclerosis
Intervention Not Provided
Study Groups/Cohorts
  • Patient Controls
    a target population of 20 patient controls will also be enrolled. These individuals will have diseases that share clinical, imaging, or biological features with MS.
  • Patients with multiple sclerosis
    Up to 100 adults (age greater than or equal to 18) with MS, diagnosed by applicable consensus criteria, and by the best judgment of the investigators, at the time of enrollment.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 20, 2016)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 26, 2085
Estimated Primary Completion Date February 26, 2080   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:
  • Diagnosis of MS according to consensus criteria at the time of enrollment OR diagnosis of a disease that shares clinical, imaging, or biological features with MS.
  • Age greater than or equal to 18.
  • Able to participate in study procedures and provide high-quality clinical research data (for example, prior MRI scans show ability to tolerate the MRI scan with minimal motion artifact).
  • Agrees to return to NIH for follow-up visits approximately annually until the time of autopsy. Note: participants who become too sick to return to NIH will not be removed from the study.
  • Agrees to undergo autopsy with donation of at least the brain, spinal cord, and retinas.
  • Able to provide informed consent at the time of initial study enrollment and willing to appoint a Durable Power of Attorney (DPA) if an advanced directive is not already in place.
  • Simultaneously participates in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry.
  • Eligible NIH employees and staff may participate.

EXCLUSION CRITERIA:

Unwilling to allow sharing and/or use in future studies of coded samples and data that are collected for this study.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Joan M Ohayon, C.R.N.P. (301) 496-3825 eatonj@ninds.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02659956
Other Study ID Numbers 160055
16-N-0055
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Study Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators Not Provided
Investigators
Principal Investigator: Daniel S Reich, M.D. National Institutes of Health Clinical Center (CC)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date November 21, 2019