NCT07723599

Brief Summary

This observational, longitudinal study will examine whether physical activity and other potentially modifiable lifestyle factors are associated with changes in myelin, the protective coating around nerve fibers, in older adults with multiple sclerosis (MS). Participants will undergo magnetic resonance imaging (MRI) scans to measure myelin throughout the central nervous system and will wear wrist-worn activity trackers to assess physical activity over time.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
11mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

July 15, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

remyelinationdemyelinationphysical activitymultiple sclerosis

Outcome Measures

Primary Outcomes (1)

  • Quantitative MRI-derived myelin measure

    Change in MRI-derived measures of myelin content within the central nervous system. Specifically, the investigators will use macromolecular proton fraction (MPF), a quantitative MRI parameter which describes the magnetization transfer effect and defined as the relative amount of protons bound to biological macromolecules with restricted molecular motion.

    Baseline and 6 months

Secondary Outcomes (7)

  • Total step count

    Continuously collected during the 6-month study period

  • Self-reported physical activity

    Baseline and monthly for the 6-month study period

  • Multiple Sclerosis Functional Composite (MSFC)

    baseline and 6 months

  • Low Contrast Letter Acuity

    Baseline and 6 months

  • Time spent in moderate-to-vigorous physical activity (MVPA)

    Throughout the 6-month period

  • +2 more secondary outcomes

Other Outcomes (10)

  • Physical Function

    Baseline and 6 months

  • Diet Quality

    Baseline and monthly for the 6-month study period.

  • Sleep Quality

    Baseline and monthly for the 6-month study period.

  • +7 more other outcomes

Study Arms (1)

Adults With Multiple Sclerosis

Participants with multiple sclerosis, age 50-70 (inclusive) will undergo quantitative MRI assessments, wearable activity monitoring, and questionnaire-based assessments over the study period.

Other: Observation

Interventions

No intervention is administered. Participants undergo observational assessments including MRI, wearable activity monitoring, and questionnaires.

Adults With Multiple Sclerosis

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will include adults age 50-70 (inclusive) with a diagnosis of multiple sclerosis in the Greater Seattle area.

You may qualify if:

  • Diagnosis of multiple sclerosis
  • Independent with ambulation (able to walk 500m without aid)
  • Disease duration \>10 years
  • Age 50 to 70 years (inclusive)
  • Be able to read, speak, and understand English

You may not qualify if:

  • Diagnosis of other neurologic disease that would interfere with interpretation such as stroke, myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), neuromyelitis optica (NMO), and sarcoidosis.
  • Inability to complete study procedures (including obtaining MRI at BMIC and using Fitbit connected to smartphone)
  • Currently participating in another clinical trial on remyelination
  • Pregnancy. (Pregnancy status will be asked at screening and before each MRI. Pregnancy testing will not be offered as part of this study.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Sclerosis Center at UW Medical Center - Northwest

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Multiple SclerosisDemyelinating DiseasesMotor Activity

Interventions

Observation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Susan R Robles, BS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Rehabilitation Medicine

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 23, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Study data may be shared in de-identified form with outside researchers and collaborators as requested and deemed acceptable by study investigators.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations