Prospective Investigation of Multiple Sclerosis in the Three Rivers Region (PROMOTE)

University of Pittsburgh

Status: Enrolling

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT02994121

STUDY19080007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,500 estimated patients

Sex: All

Ages: 7+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

7,500 participants in 2 patient groups

People with Multiple Sclerosis or Related Disorders

Description:

Individuals must be 7 years or older, diagnosed with 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

People without Multiple Sclerosis or Related Disorders

Description:

Control participants must be 7 years or older, have no known personal history of multiple sclerosis or related disorders, no other chronic disease, and can be a family member, unrelated household control, or control from the general population.