Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT07011914

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Multiple Sclerosis

Study ID

NCT07011914

Start date

Oct 23, 2025

Status verified date

Apr, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Aim 1: Adults with RRMS - Focus Groups

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

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

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.

Primary outcome measure

  • Severity of MS [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Taj Adams

646-501-7528Taj.Adams@nyulangone.org

Josselyn Zavaka

646-501-7504Josselyn.Zavala@nyulangone.org

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator:

Yolanda Wheeler, NP, PhD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Principal Investigator:

Emmanuelle Waubant, MD, PhD

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Teri Schreiner, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Tanuja Chitnis, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Aaron Abrams, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Mirjana Maletic-Savatic, MD

More Information

Sponsor

NYU Langone Health

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-05.