Care in Multiple Sclerosis (MS)

Not yet recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT07011914
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Study Start: 2025-09-01
• Primary Completion: 2029-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 386

Inclusion Criteria

Aim 1 -

• aged ≥18 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of MS	Baseline	Severity of MS will be measured by MRI FLAIR lesion volume among Aim 2 participants.

Secondary Outcome Measures

Name	Time	Method
Age of MS Onset	Baseline	Age of MS onset will be measured by interval between date of birth and MS symptom onset.

Trial Locations

Locations (6)

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