Multiple SclerosisNCT07011914
Care in Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis, run by NYU Langone Health at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 300 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Oct 2025to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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 -
Show all 17Show fewer
- 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.
Who cannot join
- Primary or Secondary Progressive MS
- Inability to consent.
- MS relapse within 30 days prior to study entry
- Other major neurologic or psychiatric illness
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Teri Schreiner, MD
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Yolanda Wheeler, NP, PhD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Tanuja Chitnis, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Aaron Abrams, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Mirjana Maletic-Savatic, MD
Timothy Lotze, MD
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
Emmanuelle Waubant, MD, PhD
About this study
Official title: CARE in MS: Childhood Adversity Research Effort in 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).
Read more
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.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1: Adults with RRMS - Focus Groups | Aim 1 will involve 2-3 focus groups, each with 8-12 participants per group. The focus group sessions will occur only one time and will take around 90-120 minutes. Aim 1 will enroll individuals with RRMS who self-identify as a Black, Hispanic, or poverty-impacted. | |
| Aim 2: Young Adults with MS - MRI Scan | Participants enrolled in Aim 2 will complete a baseline visit and research MRI occurring around and in concurrence with their routine/standard of care visit. The study visit is estimated to take around 1 to 1.5 hours. The MRI scan is estimated to take 30 minutes. The research team will maintain contact with study participants at least annually (up to 4 years). Aim 2 will enroll 330 young adults, of whom 165 have pediatric-onset RRMS and 165 have adult-onset RRMS. Further, 70% of participants in Aim 2 must self-identify as persons with MS who are either Black, Hispanic, or poverty-impacted. | |
| Aim 3: Young Adults with MS - Interviews | Aim 3 will involve one-time interviews estimated to take 30 to 45 minutes to complete. Aim 3 will enroll 20 participants who have completed at least 80% of study data in Aim 2; further, 70% of participants enrolled Aim 3 participants must self-identify as Black, Hispanic, or meet criteria for poverty impacted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of MS
Severity of MS will be measured by MRI FLAIR lesion volume among Aim 2 participants.
Measured: Baseline
Secondary outcomes (1)
Age of MS Onset
Age of MS onset will be measured by interval between date of birth and MS symptom onset.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start23 Oct 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Lauren Krupp, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011914
- Sponsor's protocol ID
- 24-00939
- Other IDs
- 1R01NS139999
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: kimberly.oneill@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARE in MS: Childhood Adversity Research Effort in MS
- ClinicalTrials.gov ID
- NCT07011914
- Acronym / sponsor ID
- 24-00939
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Adults with RRMS - Focus Groups | – | –Aim 1 will involve 2-3 focus groups, each with 8-12 participants per group. The focus group sessions will occur only one time and will take around 90-120 minutes. Aim 1 will enroll individuals with RRMS who self-identify as a Black, Hispanic, or poverty-impacted. |
| Aim 2: Young Adults with MS - MRI Scan | – | –Participants enrolled in Aim 2 will complete a baseline visit and research MRI occurring around and in concurrence with their routine/standard of care visit. The study visit is estimated to take around 1 to 1.5 hours. The MRI scan is estimated to take 30 minutes. The research team will maintain contact with study participants at least annually (up to 4 years). Aim 2 will enroll 330 young adults, of whom 165 have pediatric-onset RRMS and 165 have adult-onset RRMS. Further, 70% of participants in Aim 2 must self-identify as persons with MS who are either Black, Hispanic, or poverty-impacted. |
| Aim 3: Young Adults with MS - Interviews | – | –Aim 3 will involve one-time interviews estimated to take 30 to 45 minutes to complete. Aim 3 will enroll 20 participants who have completed at least 80% of study data in Aim 2; further, 70% of participants enrolled Aim 3 participants must self-identify as Black, Hispanic, or meet criteria for poverty impacted. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (4 listed)
- Primary or Secondary Progressive MS
- Inability to consent.
- MS relapse within 30 days prior to study entry
- Other major neurologic or psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severity of MS
Time frame: Baseline
Severity of MS will be measured by MRI FLAIR lesion volume among Aim 2 participants.
1 secondary outcome
Age of MS Onset
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: kimberly.oneill@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Krupp, MD principal investigator
NYU Langone Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by NYU Langone Health at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taj Adams (646-501-7528, Taj.Adams@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of MS (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.