MS PATHS Normative Sub-Study

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.

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Key information

Conditions

Healthy Volunteer

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Carl Gustav Carus Dresden, Dresden, Germany

Who can participate

Healthy volunteers accepted: Yes

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

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 exclusion criteria, including claustrophobia, inability to lay still in the magnet (e.g., tremor), or any type of implanted metal in the body that would be affected by the strong magnetic field.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

Primary outcomes

Brain volume

Time frame: Every 12 months up to 3 years

Measured by using magnetic resonance imaging (MRI) scans
Brain volume change

Time frame: Every 12 months up to 3 years

Measured by using MRI scans

Secondary outcomes

Development of models to calibrate brain volume measurements between centers, if necessary

Time frame: Up to 3 years

Measured by using MRI scans

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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)

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Dec 19, 2016
Registry last updated: Feb 24, 2023

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.

Published trials that share one or more normalized conditions with this study.

Completed