MS PATHS Normative Sub-Study

Longitudinal Brain Volume Change (and Correlates) in Healthy Control Subjects: A Normative Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02996084

Enrollment

246

Registered

2016-12-19

Start date

2017-12-12

Completion date

2022-12-31

Last updated

2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Imaging research

Brief summary

The primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use the results of the primary endpoint to ensure consistency of brain volume measurements across MS PATHS centers.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local participant privacy regulations. Key

Exclusion criteria

* History of human immunodeficiency virus. * Confirmed or suspected pregnancy. * Diagnosis of migraine requiring medication or any other participant-reported diagnosis of a neurological disease or condition (e.g., stroke, transient ischemic attack, epilepsy, brain infection, brain surgery, prior head injury or concussion, or brain tumor). * Any participant-reported diagnosis of an autoimmune disorder (e.g., rheumatoid arthritis, Sjögren's syndrome, scleroderma, or systemic lupus erythematosus). * Standard MRI

Design outcomes

Primary

Measure	Time frame	Description
Brain volume	Every 12 months up to 3 years	Measured by using magnetic resonance imaging (MRI) scans
Brain volume change	Every 12 months up to 3 years	Measured by using MRI scans

Secondary

Measure	Time frame	Description
Development of models to calibrate brain volume measurements between centers, if necessary	Up to 3 years	Measured by using MRI scans

Countries

Germany, Spain, United States

Outcome results