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Recruiting NCT02994121

Prospective Investigation of Multiple Sclerosis in the Three Rivers Region

Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: from 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Establish a prospective cohort of well-characterized MS patients and controls [Time frame: within 30 years]
  • Investigate the predictors of the variations in disease trajectory and treatment response [Time frame: within 30 years]

Eligibility criteria

Inclusion criteria

  • Inclusion criteria for MS patients include:
  • Age 7 years or older
  • 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)
  • 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:
  • Age 7 years or older
  • 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)
  • No known personal history of multiple sclerosis or related disorders
  • No other chronic diseases
  • Family members, unrelated household controls, or controls from the general population could be eligible

There is no exclusion criteria.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT02994121 · STUDY19080007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗