MS PATHS Normative Sub-Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02996084 |
Recruitment Status :
Active, not recruiting
First Posted : December 19, 2016
Last Update Posted : January 6, 2021
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Condition or disease |
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Healthy Volunteer |
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official 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) |
Actual Study Start Date : | December 12, 2017 |
Estimated Primary Completion Date : | December 15, 2022 |
Estimated Study Completion Date : | December 15, 2022 |

- 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
- Development of models to calibrate brain volume measurements between centers, if necessary [ Time Frame: Up to 3 years ]Measured by using MRI scans
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996084
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Missouri | |
Washington University | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, Ohio | |
The Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
Germany | |
University Hospital Carl Gustav Carus Dresden | |
Dresden, Germany | |
Spain | |
Multiple Sclerosis Centre of Catalonia (Cemcat) Vall d'Hebron Hospital | |
Barcelona, Spain |
Study Director: | Medical Director | Biogen |
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT02996084 |
Other Study ID Numbers: |
888MS005 |
First Posted: | December 19, 2016 Key Record Dates |
Last Update Posted: | January 6, 2021 |
Last Verified: | January 2021 |
Imaging research |