Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001248
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
1999-11-03
Brief Title:
Magnetic Resonance Imaging MRI to Evaluate Activity of Multiple Sclerosis MS
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Progression in Multiple Sclerosis by Magnetic Resonance Imaging MRI
Status:
RECRUITING
Status Verified Date:
2024-10-01
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:
Studies performed under 89-N-0045 are designed to examine the natural history of multiple sclerosis MS using MRI and immunological measures In addition to studying the natural history of untreated patients the natural history of patients receiving approved disease-modifying therapies of MS will be examined In both cohorts of patients levels of disease activity on MRI will be compared with immunological characteristics in order to help identify disease mechanism Patients with either definite MS based either on clinical or combined clinical and MRI criteria or with an initial presentation of neurological dysfunction consistent with MS will be studied longitudinally by MRI Disease activity on MRI will be assessed using several MRI measures of disease activity including the number of contrast enhancing lesions the overall burden of disease brain atrophy and measures to assess axonal damage Patients will be assessed clinically and correlations between immunological and genetic factors and disease activity as seen clinically or by MRI will be studied
A second cohort of patients starting the use of approved therapy will also be examined Patients referred to NIH prior to beginning approved therapy will be assessed with a series of three monthly MRIs to determine the level of pretreatment disease activity After beginning approved therapy under the direction of their private physician patients will be followed similarly to the natural history cohort Immunological and genetic findings will be accessed before and during therapy in order to help establish the mechanisms of action of the therapies and to identify mechanisms accounting for either a response or lack of response to therapy Part of the collected samples willl be cryopreserved to provide respository for further studies focusing on detection of biomarkers indicative of disease state disease stage or repsonse to therapies
Additionally a cohort of normal volunteers will be studied The studies in the normal volunteers will be used to establish the most appropriate imaging sequences for studying normal white matter in MS patients using magnetization transfer MT imaging sequences for studying normal white matter in MS patients using magnetization transfer MT imaging and to provide normative immunological measures
A second cohort of patients starting the use of approved therapy will also be examined Patients referred to NIH prior to beginning approved therapy will be assessed with a series of three monthly MRIs to determine the level of pretreatment disease activity After beginning approved therapy under the direction of their private physician patients will be followed similarly to the natural history cohort Immunological and genetic findings will be accessed before and during therapy in order to help establish the mechanisms of action of the therapies and to identify mechanisms accounting for either a response or lack of response to therapy Part of the collected samples willl be cryopreserved to provide respository for further studies focusing on detection of biomarkers indicative of disease state disease stage or repsonse to therapies
Additionally a cohort of normal volunteers will be studied The studies in the normal volunteers will be used to establish the most appropriate imaging sequences for studying normal white matter in MS patients using magnetization transfer MT imaging sequences for studying normal white matter in MS patients using magnetization transfer MT imaging and to provide normative immunological measures
Detailed Description:
Study Description
This study is primarily designed to examine the evolving natural history of multiple sclerosis MS and its mimickers viewed through the window of neuroimaging especially magnetic resonance imaging or MRI After required baseline evaluation follow-up study timepoints are driven by clinical standard-of-care and data from clinically driven procedures may be analyzed for research Optional research procedures may also be performed during these visits Optional research-only visits may be scheduled to further investigate findings from the clinical visits The same research procedures may be performed in healthy volunteers to assess whether the research findings are specific to the affected participant group
Objectives
To describe the evolving natural history of MS viewed clinically radiologically and biologically both prior to and after the introduction of increasingly effective disease modifying therapies DMT The protocol has three other important objectives 1 screening prospective participants for selected NINDS Neuroimmunology Clinic trials 2 studying healthy volunteers for comparison with affected participants and for development of new experimental technologies and 3 comparing MS to other neurological diseases that share imaging or clinical features
Endpoints
The primary endpoint is the rate of change in the number of new white matter lesions per participant indexed by the date of baseline evaluation
This study is primarily designed to examine the evolving natural history of multiple sclerosis MS and its mimickers viewed through the window of neuroimaging especially magnetic resonance imaging or MRI After required baseline evaluation follow-up study timepoints are driven by clinical standard-of-care and data from clinically driven procedures may be analyzed for research Optional research procedures may also be performed during these visits Optional research-only visits may be scheduled to further investigate findings from the clinical visits The same research procedures may be performed in healthy volunteers to assess whether the research findings are specific to the affected participant group
Objectives
To describe the evolving natural history of MS viewed clinically radiologically and biologically both prior to and after the introduction of increasingly effective disease modifying therapies DMT The protocol has three other important objectives 1 screening prospective participants for selected NINDS Neuroimmunology Clinic trials 2 studying healthy volunteers for comparison with affected participants and for development of new experimental technologies and 3 comparing MS to other neurological diseases that share imaging or clinical features
Endpoints
The primary endpoint is the rate of change in the number of new white matter lesions per participant indexed by the date of baseline evaluation
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 |
|---|---|---|---|
| 89-N-0045 | None | None | None |