Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT01617395
Eligibility Criteria:
* INCLUSION CRITERIA:
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 150):
* Referred by Columbia University Medical Center 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 Columbia University Medical Center as having a GERS in the top 20% of the overall GEMS study.
* Willing to undergo additional study procedures at the NIH for up to 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 Clinic 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 participant.
* Able and willing to send medical records associated with their MS diagnosis to NIH.
* Healthy volunteer cohort (target n=80)
* Age 18-50, inclusive.
* No known first-degree relative (parent, sibling, or child) with MS.
* All cohorts
* Able to give informed consent.
EXCLUSION CRITERIA:
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)
--None
* 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.
Eligible NIH employees and staff may participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01617395
Study Brief:
Protocol Section:
NCT01617395