Pathological Basis of MRI Signal Changes in Multiple Sclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02659956|
Recruitment Status : Recruiting
First Posted : January 21, 2016
Last Update Posted : August 3, 2022
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.
To understand how the physical and clinical signs of MS relate to its changes over time.
Adults age 18 or older with MS or a disease of the brain and spinal cord that may act like MS.
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.
|Condition or disease|
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.
This study will enroll up to 150 individuals with MS, targeting 50 study completers, across various ages and stages of the disease, as well as 50 appropriate disease and non-neurological control participants, for a total of 200 participants.
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.
This is a multi-site study with Johns Hopkins University. Some analysis of identifiable data will be conducted at Johns Hopkins University JHU under a reliance agreement. Patients will not be consented to the study or participate in study interventions/procedures at JHU.
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|
|Estimated Enrollment :||200 participants|
|Official Title:||The Pathological Basis of MRI Signal Changes in Multiple Sclerosis: A Longitudinal In Vivo-to-Postmortem Study|
|Actual Study Start Date :||April 7, 2016|
|Estimated Primary Completion Date :||February 26, 2080|
|Estimated Study Completion Date :||February 26, 2080|
Individuals without known CNS disease
Family members of patient participants
a target population of 50 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 150 adults (age >= 18) with MS, diagnosed by applicable consensus criteria, and by the best judgment of the investigators, at the time of enrollment.
- 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.
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): NCT02659956
|Contact: Joan M Ohayon, C.R.N.P.||(301) email@example.com|
|Contact: Daniel S Reich, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Daniel S Reich, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|