Multicenter ALS Imaging Study
Multicenter Longitudinal Imaging in ALS for Disease Biomarker Development
University of Minnesota
90 participants
Sep 15, 2024
OBSERVATIONAL
Conditions
Summary
This is a multi-site study of ALS participants and healthy controls who will undergo brain and cervical spine MRIs and NfL blood testing at up-to 4 time points over the course of a year. The primary goal is to identify objective biomarkers of disease progression that are biologically relevant, linearly progressive, and sensitive to change.
Eligibility
Inclusion Criteria7
- For participants with ALS:
- < 36 months since onset of symptoms
- Definite, probable, lab supported-probable or possible ALS by El Escorial criteria OR definite, probable or possible ALS per Awaji-Shima Criteria
- Forced vital capacity within the last 90 days ≥ 60% of the predicted value
- Able to consent for themselves
- Able to read and speak English
- Clear of any contraindications for MRI
Exclusion Criteria2
- Individuals will be excluded if they have any condition that makes MRI unsafe or if they are unable to comply with instructions.
- All participants will undergo a neurologic examination at enrollment. Control participants with clinically significant abnormal findings on neurological examination will be excluded from the study.
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Interventions
Participants will undergo 3T MRI scanning of the brain and cervical spine MRIs
Participants will undergo a blood draw for the quantification of plasma neurofilament light chain
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06735014