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Care in Multiple Sclerosis (MS)

CARE in MS: Childhood Adversity Research Effort in MS

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Procedures mentioned: Blood draws, MRI scans, Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how hard childhood experiences affect multiple sclerosis (MS) and how social factors affect quality of life. It focuses on people with relapsing-remitting MS, especially Black, Hispanic, and low-income people. One part includes two visits with a blood draw and an MRI scan.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Aims 1 and 2: Have relapsing-remitting MS, a type with flare-ups and periods of recovery.
  • Aims 1 and 2: The listed age range is unclear (written as “≥18–29”). Ask the study team to confirm.
  • Aim 1: Speak English or Spanish fluently. Aim 2: Read English or Spanish fluently.
  • The study aims for 70% of participants to be Black, Hispanic, or low-income. Aim 1 defines low income as no more than 138% of the federal poverty level.
  • Aim 2: If MS started before age 18, be age 18–25 when joining. If MS started at age 18 or older, be age 19–29 when joining.
  • Aim 2: Have had MS for less than 8 years.
  • Aim 3: Be among the first 20 eligible Aim 2 participants and have completed at least 80% of Aim 2 study data.
  • Aim 3: Interviews will include equal numbers of people with scores in the highest and lowest quarters on the PROMIS-10 health survey.

Who can't join

  • Have primary or secondary progressive MS, types in which symptoms get worse over time.
  • Cannot give informed consent, meaning you cannot understand and agree to take part.
  • Had an MS flare-up within 30 days before joining.
  • Have another major illness affecting the brain or nerves, or a major mental health condition.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (6)

AL

  • University of Alabama at Birmingham · Birmingham, AL 35294Yolanda Wheeler, NP, PhD · Principal investigatorMore trials in Birmingham

CA

  • University of California, San Francisco · San Francisco, CA 94158Emmanuelle Waubant, MD, PhD · Principal investigatorMore trials in San Francisco

CO

  • University of Colorado Denver · Aurora, CO 80045Teri Schreiner, MD · Principal investigatorMore trials in Aurora

MA

  • Massachusetts General Hospital · Boston, MA 02114Tanuja Chitnis, MD · Principal investigatorMore trials in Boston

OH

TX

  • Baylor College of Medicine · Houston, TX 77030Mirjana Maletic-Savatic, MD · Principal investigatorTimothy Lotze, MD · Principal investigatorMore trials in Houston