Care in Multiple Sclerosis (MS)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
NYU Langone Health
Study ID
NCT07011914
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Oct 23, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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

Locations (6)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Yolanda Wheeler, NP, PhD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94158
Emmanuelle Waubant, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Colorado DenverAuroraColorado80045
Teri Schreiner, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Tanuja Chitnis, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Aaron Abrams, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Mirjana Maletic-Savatic, MD (PRINCIPAL_INVESTIGATOR)
Timothy Lotze, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Multiple sclerosis
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NeurologyBrain disordersAutoimmune disease
By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California, San Francisco· San Francisco, CAUniversity of Colorado Denver· Aurora, COMassachusetts General Hospital· Boston, MACleveland Clinic· Cleveland, OHBaylor College of Medicine· Houston, TX

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