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Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)

Study Purpose

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. ...

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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INCLUSION CRITERIA:
- One of the following: - Diagnosis of MS or clinically isolated syndrome based on currently accepted diagnostic criteria.

- Presentation with neuroimaging features consistent with MS.

- Diagnosis of another disease of the CNS.

- Healthy volunteer.

- Age greater than or equal to 18.

- Able to give informed consent.

NIH employees are eligible to participate.

EXCLUSION CRITERIA:

- Contraindication to MRI.

- Pregnancy.

- Unwilling to allow coded samples to be processed offsite or unwilling to have coded samples used in other studies.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00001248
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Daniel S Reich, M.D.
Principal Investigator Affiliation	National Institute of Neurological Disorders and Stroke (NINDS)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis
Study Website:	View Trial Website

Additional Details

Studies performed under 89-N-0045 are 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). The protocol has four other important objectives:

(1) Screening prospective participants for selected NINDS Neuroimmunology Clinic trials; (2) Performing studies to help define the mechanism of action and cause of side effects of disease modifying therapies (DMT); (3) Studying healthy volunteers for comparison with patients and for development of new experimental technologies; and (4) Comparing MS to other neurological diseases that share imaging features.

To the extent possible, scheduled testing performed under this protocol will coincide with standard-of-care evaluations for diagnosis and longitudinal clinical management, thereby reducing the burden of research participation by participants. Such testing may involve state-of-the-art research methods. Additional pure-research visits may be scheduled to further investigate findings observed on scheduled visits and/or outside studies. Disease activity on MRI will be assessed using several MRI measures, including the detection of new on-study lesions, quantification of contrast-enhancing lesions, the total number and/or volume of MRI-visible lesions, brain volume and brain volume change, and more advanced MRI measures of tissue damage, such as quantitative magnetic relaxation mapping, diffusion-weighted imaging (DWI), magnetization transfer imaging (MTI), and MR spectroscopy (MRS). Participants may be assessed with other imaging modalities, including optical coherence tomography (OCT), and they will be asked to provide research samples (generally blood, but also saliva and cerebrospinal fluid) and be studied clinically. In order to obtain comparative data for proper interpretation of the results in MS, two control cohorts

- one consisting of patients, the other of healthy volunteers - will be studied.

The patient control cohort will include patients with other CNS diseases that may share pathophysiological processes with MS patients (e.g. other inflammatory conditions of the central nervous system, mitochondrial disorders, leukodystrophies, neurodegenerative diseases that may cause axonal loss or oxidative stress, or cerebral small vessel disease). Enrollment of these control patient populations will help to answer the question of whether the identified MRI findings and/or pathophysiological mechanisms are MS-specific or generalizable.

Arms & Interventions

Arms

: healthy volunteers

Healthy volunteers for technique development and comparison with the patient populations.

: MS/CIS/RIS population

Patients with a diagnosis of MS or who have typical imaging abnormalities associated with MS.

: Non-MS comparison population

Patients with disorders of the CNS, to include patients with diseases that share mechanisms of tissue damage with MS

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

[email protected]

800-411-1222 #TTY dial 711

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