MS and NMOSD in African-Americans

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Multiple Sclerosis; Neuromyelitis Optica

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

African American patients who have been diagnosed with MS and later diagnosed as having NMOSD. They will be patients that have been seen in the Kentucky Neuroscience Institute (KNI). The age range will be 18-80.

Description

Inclusion Criteria:

• between the ages of 18 and 80
• are African-American
• have a diagnosis of MS and later diagnosis of NMOSD
• have been seen at the University of Kentucky's Kentucky Neuroscience Institute

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
African Americans with MS; African American patients seen in the University of Kentucky's Multiple Sclerosis Clinic between the ages of 18 and 80 who have been diagnosed with MS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical data collection and comparison	Collect patient age, sex, date of birth, and date of diagnosis to examine trends among this population.	Through study completion, average duration of four years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI analysis	Analyze MRIs of subjects to see how lesions contribute to this disorder over the course of the study.	Through study completion, average duration of four years
Diagnostic tests collection and comparison	Collect blood tests, CSF studies, mimic conditions, and AQP4 testing will be collected and analyzed for changes over the course of the study and compared to other patients in the study.	Through study completion, average duration of four years

Collaborators and Investigators

• Sponsor: Jagannadha R Avasarala

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: MS; multiple sclerosis; African Americans; Neuromyelitis optica spectrum disorder; NMOSD
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Optic Neuritis; Multiple Sclerosis; Sclerosis; Neuromyelitis Optica
• Other Study ID Numbers: 51232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No