Care in Multiple Sclerosis (MS)
Recruiting · NCT07011914 · Observational (researchers observe without assigning treatment) · Lead sponsor: NYU Langone Health
View the official record on ClinicalTrials.gov →What this trial is about
This study is structured around three main aims. In Aim 1, investigators will conduct community-based participatory research (CBPR) to develop culturally tailored methods to assess childhood adversity in multiple sclerosis (MS). Aim 2 will investigate the impact of childhood adversity on MS outcomes among individuals with relapsing-remitting MS (RRMS), among whom 70% belong to a group historically under-represented in MS research: Black, Hispanic, or poverty-impacted. Aim 2 procedures involve two visits that include a research blood draw and an MRI scan. In Aim 3, investigators will conduct interviews and surveys to explore environmental and social factors affecting quality of life for minority MS patients.
Who can take part
Inclusion criteria
- Aim 1 -
- aged ≥18-29 years
- diagnosis of RRMS (Fulfill international criteria for relapsing remitting (RRMS))
- 70% self-identifying as a Black, Hispanic, or poverty-impacted (up to 138% of the federal poverty level) individual,and
- fluent in English or Spanish.
- Aim 2 -
- aged ≥18-29 years
- diagnosis of RRMS (Fulfill international criteria for relapsing remitting (RRMS))
- 70% self-identifying as a Black, Hispanic, or poverty impacted, and
- fluent reading in English or Spanish
- Pediatric onset MS (MS onset before age 18 and age at time of enrollment is 18-25) OR adult-onset MS (MS onset at age 18 or older and age at time of enrollment is 19-29)
- Disease duration below 8 years
- Aim 3 -
- Aim 3 will enroll the first 20 participants from Aim 2 who meet the following criteria:
- completed at least 80% of study data in the cross-sectional study/Aim 2.
- a total of 70% must self-identify as Black, Hispanic, or meet criteria for poverty impacted.
- interviews will be evenly split between participants with high (top quartile) and low (bottom quartile) of PROMIS-10 scores.
Exclusion criteria
- Primary or Secondary Progressive MS
- Inability to consent.
- MS relapse within 30 days prior to study entry
- Other major neurologic or psychiatric illness
Where it is running
6 locations listed across 6 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- University of California, San Francisco - San Francisco, California, United States
- University of Colorado Denver - Aurora, Colorado, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Baylor College of Medicine - Houston, Texas, United States