NCT04131673

MS and NMOSD in African-Americans

MS and NMOSD in African-Americans: a Prospective Data Collection Protocol Using REDCap

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Jagannadha R Avasarala · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective study that aims to collect and review neuromyelitis optica spectrum disorder (NMOSD) data from African American patients with a known diagnosis of multiple sclerosis (MS). It is an investigational study, prospective in nature. No randomization of patients will be done. Information collected includes: Age, gender, age at diagnosis, MRI data (access to images), clinical presentation, findings on clinical examination, lab (blood and evoked potentials) and LP test results, eye exam findings if any and treatment, if started. Additional details may include other NEUROLOGICAL diseases which are also diagnosed (if any).

Detailed description

African-Americans with MS are high risk for ambulatory difficulty given aggressive disease phenotype. Disease responsiveness to FDA-approved drugs is also marginal at best. A positive correlation between the presence of oligoclonal bands (OCBs) and progressive course of MS has been established even when adjusted for ethnicity. It is well documented that the CSF humoral immune response, including a higher IgG index is higher in African-American MS patients. Although MRI lesions, specifically cord and infra-tentorial regions, contribute to disability, the phenotype in African-American populations is also probably linked to HLA-antigen complex. No study has ever collected data as it relates to ethnic background and MS. The University of Kentucky would be the first institution to collect such data. This is a prospective study that will collect data from patients with the known diagnosis of MS who were later classified as NMOSD from the University of Kentucky's Multiple Sclerosis Clinic. Researchers will use REDCap to store data.

Conditions

• Multiple Sclerosis
• Neuromyelitis Optica

Timeline

• Start date: 2019-07-05
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-10-18
• Last updated: 2022-11-14

Locations

1 site across 1 country: United States