Care in Multiple Sclerosis (MS)

NYU Langone Health

Status: Enrolling

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07011914

24-00939

1R01NS139999 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 386 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

386 participants in 3 patient groups

Aim 1: Adults with RRMS - Focus Groups

Description:

Aim 1 will involve 2-3 focus groups, each with 8-12 participants per group. The focus group sessions will occur only one time and will take around 90-120 minutes. Aim 1 will enroll individuals with RRMS who self-identify as a Black, Hispanic, or poverty-impacted.

Aim 2: Young Adults with MS - MRI Scan

Description:

Participants enrolled in Aim 2 will complete a baseline visit and research MRI occurring around and in concurrence with their routine/standard of care visit. The study visit is estimated to take around 1 to 1.5 hours. The MRI scan is estimated to take 30 minutes. The research team will maintain contact with study participants at least annually (up to 4 years). Aim 2 will enroll 330 young adults, of whom 165 have pediatric-onset RRMS and 165 have adult-onset RRMS. Further, 70% of participants in Aim 2 must self-identify as persons with MS who are either Black, Hispanic, or poverty-impacted.

Aim 3: Young Adults with MS - Interviews

Description:

Aim 3 will involve one-time interviews estimated to take 30 to 45 minutes to complete. Aim 3 will enroll 20 participants who have completed at least 80% of study data in Aim 2; further, 70% of participants enrolled Aim 3 participants must self-identify as Black, Hispanic, or meet criteria for poverty impacted.