Care for young adults with relapsing-remitting MS
CARE in MS: Childhood Adversity Research Effort in MS
This project will test culturally tailored ways to measure childhood adversity and see if past adversity links to blood, MRI, and quality-of-life outcomes in young adults with relapsing-remitting MS, prioritizing Black, Hispanic, and low-income participants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 6 sites (Birmingham, Alabama and 5 other locations) |
| Trial ID | NCT07011914 on ClinicalTrials.gov |
What this trial studies
The project uses community-based participatory research to develop culturally tailored measures of childhood adversity for people with MS. In a cross-sectional arm, eligible young adults with relapsing-remitting MS will attend two visits including a research blood draw and MRI to examine relationships between adversity and clinical, imaging, and laboratory outcomes. A subset of participants will complete interviews and surveys to explore environmental and social factors that affect quality of life among minority and underrepresented MS patients. The work is conducted across multiple U.S. academic sites with involvement from a federal neurological institute.
Who should consider this trial
Good fit: Ideal candidates are 18–29-year-olds with relapsing-remitting MS who can read English or Spanish, with an emphasis on those who self-identify as Black, Hispanic, or are low-income and who meet the study's onset and disease-duration windows.
Not a fit: Older adults, people with progressive forms of MS, non-English/Spanish speakers, or those with disease duration beyond the study limits are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, this work could lead to culturally appropriate screening for childhood adversity and more targeted supports that improve outcomes and quality of life for young adults with RRMS.
How similar studies have performed: Previous research has linked childhood adversity to worse MS outcomes, but applying community-based, culturally tailored measurement methods in a young, underrepresented RRMS population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 5 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Krupp, MD — NYU Langone Health
- Study coordinator: Taj Adams
- Email: Taj.Adams@nyulangone.org
- Phone: 646-501-7528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.