Pathological Basis of MRI Signal Changes in Multiple Sclerosis
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2018 |
| Start Date: | January 20, 2016 |
| End Date: | February 26, 2041 |
| Contact: | Joan M Ohayon, C.R.N.P. |
| Email: | eatonj@ninds.nih.gov |
| Phone: | (301) 496-3825 |
The Pathological Basis of MRI Signal Changes in Multiple Sclerosis: A Longitudinal In Vivo-to-Postmortem Study
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.
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.
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.
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.
- 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.
EXCLUSION CRITERIA:
Unwilling to allow sharing and/or use in future studies of coded samples and data that are
collected for this study.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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