Care in Multiple Sclerosis (MS)

CARE in MS: Childhood Adversity Research Effort in MS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07011914

Enrollment

300

Registered

2025-06-10

Start date

2025-10-23

Completion date

2029-06-30

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Severity of MS	Baseline	Severity of MS will be measured by MRI FLAIR lesion volume among Aim 2 participants.

Secondary

Measure	Time frame	Description
Age of MS Onset	Baseline	Age of MS onset will be measured by interval between date of birth and MS symptom onset.

Countries

United States

Contacts

CONTACTTaj Adams

Taj.Adams@nyulangone.org646-501-7528

CONTACTJosselyn Zavaka

Josselyn.Zavala@nyulangone.org646-501-7504

PRINCIPAL_INVESTIGATORLauren Krupp, MD

NYU Langone Health

Outcome results