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MS and NMOSD in African-Americans

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04131673
Enrollment
0
Registered
2019-10-18
Start date
2019-07-05
Completion date
2023-12-31
Last updated
2022-11-14

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

Conditions

Multiple Sclerosis, Neuromyelitis Optica

Keywords

multiple sclerosis, MS, Neuromyelitis optica spectrum disorder, NMOSD, African Americans

Brief 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.

Interventions

None listed

Sponsors

Jagannadha R Avasarala
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical data collection and comparisonThrough study completion, average duration of four yearsCollect patient age, sex, date of birth, and date of diagnosis to examine trends among this population.

Secondary

MeasureTime frameDescription
MRI analysisThrough study completion, average duration of four yearsAnalyze MRIs of subjects to see how lesions contribute to this disorder over the course of the study.
Diagnostic tests collection and comparisonThrough study completion, average duration of four yearsCollect 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.

Countries

United States

Outcome results

None listed

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