Prospective Investigation of Multiple Sclerosis in the Three Rivers Region

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT02994121
• Lead Sponsor: University of Pittsburgh

Brief Summary

In this longitudinal prospective natural history study of multiple sclerosis (MS), the overarching goal is to understand the factors that influence individual variation in disease trajectory and treatment response and pave the way for realizing precision medicine in MS. Because MS is a chronic neurological disorder, this observational cohort study will span a 30-year time frame.

Detailed Description

Research Activities: Initial Questionnaire, Questionnaire for Self-Reported Outcomes, Biological Sample Collection (Blood, Stool, Urine, Cerebrospinal fluid), Genetic Analysis, Standard Quantitative Assessment of Function, Cognitive Assessment, Neuroimaging, Biometric Sensors, Social Network Questionnaire, Connor-Davidson Resilience Scale, NEO Five-Factor Inventory, and the COVID19 Response Surveys.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-01
• Last Update Posted: 2025-01-03
• Primary Completion: 2047-01
• Study Completion: 2047-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7500

Inclusion Criteria

• Inclusion criteria for MS patients include:

  1. willing and able to give consent
  2. age 7 years or older
  3. diagnosis of multiple sclerosis or related disorders, including a first central nervous system demyelinating episode with a positive MRI scan or abnormal MRI scans characteristic of MS but no clinical symptoms of the disease

• For healthy controls:

  1. Age 7 years or older
  2. Willing and able to provide consent (for >=18 years) or assent with permission from at least one of the child's parents (for <18 years)
  3. No known personal history of multiple sclerosis or related disorders
  4. No other chronic diseases
  5. Family members, unrelated household controls, or controls from the general population could be eligible

There is no exclusion criteria.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigate the predictors of the variations in disease trajectory and treatment response	within 30 years	Understanding the factors that influence disease trajectory and treatment response will pave the way to realize precision medicine in delivering individualized MS care.
Establish a prospective cohort of well-characterized MS patients and controls	within 30 years	For this longitudinal prospective observational study, we will establish a prospective cohort of well-characterized MS patients and controls (2:1).

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States