Clinical Trial Details
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NCT01617395 : Relating Genetic and Environmental Risk Scores to Multiple Sclerosis Susceptibility
AgesMin: 18 Years Max: 50 Years

GEMS cohort (target n equals 1000)

- First-degree relative (parent, sibling, or child) of a self-reported MS patient.

- Age 18-50, inclusive, at the time of enrollment into the overall GEMS study.

- Willingness to be contacted regarding additional follow-up procedures.

- Cross-sectional subcohort (target n equal 100):

- Referred by Harvard as having a genetic and environmental risk score (GERS),
defined in Section 4.1.1, in the top or bottom 20% of the overall GEMS study.

- NINDS Longitudinal subcohort (target n equal 100):

- Ages 18-40, inclusive.

- Referred by Harvard as having a GERS in the top 20% of the overall GEMS study.

- Willing to undergo additional study procedures at the NIH for 20 years, with
planned follow-up every year for participants between ages 18 and 25, every 2
years for participants between ages 26 and 30, and every 5 years for
participants between ages 31 and 40.

- Relative enrolled in NIH study with confirmation of MS diagnosis.

MS patient cohort (target n=1000):

- MS patients (NIH)

- Co-enrolled in another Neuroimmunology Branch natural history protocol.

- Diagnosis confirmed at NIH.

- Age 18 or older.

- MS patient (non-NIH)

- First-degree relative (parent, sibling, or child) of an existing GEMS

- Able and willing to send medical records associated with their MS diagnosis to

- Healthy volunteer cohort (target n=50)

- Age 18-50, inclusive.

- No known first-degree relative (parent, sibling, or child) with MS.

- All cohorts

- Able to give informed consent.


GEMS cohort

-Diagnosis of MS.

Cross-sectional and NINDS longitudinal subcohorts

- Contraindications to MRI scanning.

- Diagnosis of another central nervous system disease disease (CNS neoplasm, known
cerebrovascular disease, known CNS degenerative diseases, or known CNS inflammatory
diseases) at the time enrollment into the study.

- MS cohort (both)


- Healthy volunteer cohort

- Diagnosis of MS or another central nervous system (CNS neoplasm, cerebrovascular
disease CNS degenerative diseases, or CNS inflammatory diseases) or a systemic
disease that would interfere with the aims of this study.

- Contraindications to MRI scanning.
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