Clinical trial NCT07011914: Care in Multiple Sclerosis (MS)
Official title: CARE in MS: Childhood Adversity Research Effort in MS
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2025-06-10
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Aim 1: 2-3 focus groups, each with 8-12 participants per group., aged ≥18 years with RRMS, who self-identify as a Black, Hispanic, or poverty-impacted, and are fluent in English or Spanish.
* Aim 2: 330 young adults (ages 18-29 years of age with MS duration of 8 years or less) of whom 165 have pediatric-onset RRMS (aged 18-25) and 165 have adult-onset (aged 19-29) RRMS. 70% self-identify as persons with MS who are either Black, Hispanic, or poverty-impacted.
* Aim 3: 20 participants who have completed at least 80% of study data in the cross-sectional study/Aim 2. 70% must self-identify as Black, Hispanic, or meet criteria for poverty impacted.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Severity of MS
timeFrame: Baseline
Secondary outcomes:
measure: Age of MS Onset
timeFrame: Baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: NYU Langone Health
name: Lauren Krupp, MD
role: PRINCIPAL_INVESTIGATOR
References: