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Prospective Investigation of Multiple Sclerosis in the Three Rivers Region

Prospective Investigation of Multiple Sclerosis in the Three Rivers Region

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02994121
Acronym
PROMOTE
Enrollment
7500
Registered
2016-12-15
Start date
2016-12-31
Completion date
2047-01-31
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

None listed

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Inclusion criteria for MS patients include: 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. 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

.

Design outcomes

Primary

MeasureTime frameDescription
Establish a prospective cohort of well-characterized MS patients and controlswithin 30 yearsFor this longitudinal prospective observational study, we will establish a prospective cohort of well-characterized MS patients and controls (2:1).
Investigate the predictors of the variations in disease trajectory and treatment responsewithin 30 yearsUnderstanding the factors that influence disease trajectory and treatment response will pave the way to realize precision medicine in delivering individualized MS care.

Countries

United States

Contacts

Primary ContactZongqi Xia, MD, PhD
msstudy2@pitt.edu412-383-5377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026