Ignite Creation Date:
2024-05-06 @ 7:15 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02504840
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2015-07-21
Brief Title:
Natural History of Multiple Sclerosis and Its Mimickers
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Thematic Studies of Multiple Sclerosis and Related Diseases
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- Magnetic resonance imaging MRI has been used for decades to help diagnose and monitor neurological disorders like multiple sclerosis MS Researchers want to improve how MRI pictures are taken They also want to learn more about using newer MRIs with stronger magnets to get better pictures than standard MRIs provide
Objectives
- To collect data that will help researchers better understand MS and related diseases
Eligibility
Adults 18 and older with MS or MRI findings that appear similar to MS or with other neurological diseases that may look or act like MS
Healthy adult volunteers
Design
Participants will be screened with a review of their medical records
Participants will have a baseline visit It will include a physical exam medical history and neurological exam They may have blood tests
The study will last indefinitely
Participants may have MRIs Some MRIs may include a contrast dye For this a needle will be used to guide a thin plastic tube into an arm vein
Participants may have up to 2 lumbar punctures per year Skin will be numbed and a needle inserted between back bones will remove fluid
Participants may give saliva samples and have an eye exam
Participants may have evoked potential tests These measure how the nervous system responds to different types of stimulation Participants may sit in front of a TV and watch pictures on the screen Or they may wear earphones that make a clicking noise or static Or they may get a small electrical shock that may tingle and cause a hand or foot twitch
Participants may have tests of strength spasticity sensations balance andor walking
- Magnetic resonance imaging MRI has been used for decades to help diagnose and monitor neurological disorders like multiple sclerosis MS Researchers want to improve how MRI pictures are taken They also want to learn more about using newer MRIs with stronger magnets to get better pictures than standard MRIs provide
Objectives
- To collect data that will help researchers better understand MS and related diseases
Eligibility
Adults 18 and older with MS or MRI findings that appear similar to MS or with other neurological diseases that may look or act like MS
Healthy adult volunteers
Design
Participants will be screened with a review of their medical records
Participants will have a baseline visit It will include a physical exam medical history and neurological exam They may have blood tests
The study will last indefinitely
Participants may have MRIs Some MRIs may include a contrast dye For this a needle will be used to guide a thin plastic tube into an arm vein
Participants may have up to 2 lumbar punctures per year Skin will be numbed and a needle inserted between back bones will remove fluid
Participants may give saliva samples and have an eye exam
Participants may have evoked potential tests These measure how the nervous system responds to different types of stimulation Participants may sit in front of a TV and watch pictures on the screen Or they may wear earphones that make a clicking noise or static Or they may get a small electrical shock that may tingle and cause a hand or foot twitch
Participants may have tests of strength spasticity sensations balance andor walking
Detailed Description:
Objectives
The goals of this protocol are to study the pathophysiology of multiple sclerosis MS primarily through small studies that utilize magnetic resonance imaging MRI and to correlate the results with clinical and biological measures The protocol includes only techniques with minimal risk standard and quantitative clinical evaluation MRI blood draws saliva testing urine and stool collection visual evoked potentials ophthalmologic evaluation or more-than-minimal risk injection of approved gadolinium-based contrast agents lumbar punctures that are appropriate and common in this study population Under this protocol we will conduct
Pilot substudies These studies are exploratory and hypothesis generating Once sufficient data are collected to justify a hypothesis-driven study and a formal power analysis further work will continue under either a dedicated protocol or if appropriate a hypothesis-testing substudy There are no enrollment limitations for pilot substudies
Hypothesis-testing substudy These studies have a specific hypothesis that can be tested with at most 6 participants per arm If additional participants are required a memo will be sent to the Protocol Review Committee PIRC and its statistical reviewer to request review of a hypothesis-testing substudy for possible additional enrollmentThe memo will also be forwarded to the IRB
Individual patient substudies These studies seek to increase knowledge of a disease process or to assist in the diagnosis of an individual patient
Technique development substudies These studies will lay the groundwork for new experimental paradigms using the methods approved under this protocol which can be further tested in the substudies listed above
Training of investigators These studies will be done to train new investigators in techniques relevant to the studies under this protocol
Study Population
Three groups of study participants will be enrolled
MS patients Participants with definite probable or possible MS
Patient controls Participants with diseases that share features with MS
Healthy volunteers
Design
We will design small substudies as ideas arise in the course of our work that are pertinent to the theme of the pathophysiology of MS or of diseases that share features with MS If a hypothesis testing sub-study leads to results of interest and if a larger population is necessary to reach statistical significance a separate protocol will be submitted with a priori hypotheses specific study design and power analysis adapted from the pilot or exploratory substudies performed in the present protocol
Outcome Measures
These will include MRI clinical and biological outcome measures consistent with the objectives of the study and its investigators Imaging measures will focus on features related to the central nervous system CNS particularly focal lesions Clinical measures will include standard and established MS disability scales as well as quantitative measures related to function Biological measures will include genotype gene expression proteomics virological studies and immunological profiling
The goals of this protocol are to study the pathophysiology of multiple sclerosis MS primarily through small studies that utilize magnetic resonance imaging MRI and to correlate the results with clinical and biological measures The protocol includes only techniques with minimal risk standard and quantitative clinical evaluation MRI blood draws saliva testing urine and stool collection visual evoked potentials ophthalmologic evaluation or more-than-minimal risk injection of approved gadolinium-based contrast agents lumbar punctures that are appropriate and common in this study population Under this protocol we will conduct
Pilot substudies These studies are exploratory and hypothesis generating Once sufficient data are collected to justify a hypothesis-driven study and a formal power analysis further work will continue under either a dedicated protocol or if appropriate a hypothesis-testing substudy There are no enrollment limitations for pilot substudies
Hypothesis-testing substudy These studies have a specific hypothesis that can be tested with at most 6 participants per arm If additional participants are required a memo will be sent to the Protocol Review Committee PIRC and its statistical reviewer to request review of a hypothesis-testing substudy for possible additional enrollmentThe memo will also be forwarded to the IRB
Individual patient substudies These studies seek to increase knowledge of a disease process or to assist in the diagnosis of an individual patient
Technique development substudies These studies will lay the groundwork for new experimental paradigms using the methods approved under this protocol which can be further tested in the substudies listed above
Training of investigators These studies will be done to train new investigators in techniques relevant to the studies under this protocol
Study Population
Three groups of study participants will be enrolled
MS patients Participants with definite probable or possible MS
Patient controls Participants with diseases that share features with MS
Healthy volunteers
Design
We will design small substudies as ideas arise in the course of our work that are pertinent to the theme of the pathophysiology of MS or of diseases that share features with MS If a hypothesis testing sub-study leads to results of interest and if a larger population is necessary to reach statistical significance a separate protocol will be submitted with a priori hypotheses specific study design and power analysis adapted from the pilot or exploratory substudies performed in the present protocol
Outcome Measures
These will include MRI clinical and biological outcome measures consistent with the objectives of the study and its investigators Imaging measures will focus on features related to the central nervous system CNS particularly focal lesions Clinical measures will include standard and established MS disability scales as well as quantitative measures related to function Biological measures will include genotype gene expression proteomics virological studies and immunological profiling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-N-0158 | None | None | None |