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Recruiting

NCT Number: NCT07011914

Care in Multiple Sclerosis (MS)

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Severity of MS

    Time frame: Baseline

    Severity of MS will be measured by MRI FLAIR lesion volume among Aim 2 participants.

Secondary outcomes

  1. Age of MS Onset

    Time frame: Baseline

    Age of MS onset will be measured by interval between date of birth and MS symptom onset.

Study contacts

Contact information is provided by the study sponsor or research team.

Josselyn Zavaka

CONTACT

[email protected]

646-501-7504

Taj Adams

CONTACT

[email protected]

646-501-7528

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

CARE in MS: Childhood Adversity Research Effort in MS

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 10, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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