Understanding ALS Through Tissue Analysis and Patient Registry
This observational study aims to better understand Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease, a progressive condition causing muscle weakness. Researchers will collect information from your medical records, including physical exams and other standard tests, to monitor disease progression. You may also be asked to have an MRI scan. Additionally, the study seeks consent for a rapid autopsy after passing, to collect and bank tissue from the brain, spinal cord, nerves, and muscles for detailed cellular and molecular analysis. This research will help identify reliable markers of disease progression and lead to new approaches for treatment. You can join if you are 18-90 years old, have an established ALS diagnosis, and are willing to provide informed consent.
- Study design
- This is an observational study with a planned enrollment of 40 participants. It is not a treatment study, but rather focuses on collecting and analyzing data.
- What's involved
- You would provide consent for researchers to access your medical information and potentially undergo an MRI. You may also consent to a postmortem autopsy for tissue collection.
- Compensation
- Not stated in the trial record.
- Follow-up
- Imaging biomarkers will be measured within 6 months of enrollment. Molecular biomarkers will be measured within 12 months of a participant's passing.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Analysis of Human ALS Tissues and Registry of ALS Patients
At a glance
Conditions
NCT05067179
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Illinois at Chicago
Chicago, Illinoisstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jeffrey Loeb, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago
Who to contact
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Inclusion
Exclusion
What this trial measures
- Imaging biomarkersWithin 6 months of participant enrollment
High resolution 3T MRI T1, T2/FLAIR, DWI, SWI, MRS, and MT sequences at the cervical, thoracic, and lumbar spine and brainstem will be used to identify individual and combinatorial (of each sequence) changes to be used as clinical biomarkers of progression in cases with focal disease onset and spread. These will be compared to histologic and genomic changes in rapid postmortem tissues in the same areas. High resolution T1-weighted imaging is preferred for anatomical structure morphometry. The hypothesis is that spinal cord cross-sectional area decreases over time may be a sensitive MRI parameter to detect progression and respiratory distress. The aim is to develop a highly sensitive and specific, non-invasive measure of ALS progression in the spinal cord using a multi-parametric measurement scheme. Image sequences will be attained and a combinatorial statistical analysis performed to find the best biomarker of progression that could differ regardless of upper motor neuron involvement.
- Molecular biomarkersWithin 12 months of participant's passing
Tissue analyses will be performed to identify differentially expressed genes and histological differences from a rapid postmortem analysis of human ALS tissues from the same spinal cord levels and brainstem imaged on MRI, using an initial genomic analysis (RNAseq). Clinically meaningful biomarkers for disease progression will be validated through bioinformatics and confirmatory studies on human tissues and linked to imaging and clinical findings. Further analysis will look for differences in those with and without upper motor neuron involvement and for those taking or not taking drugs. Tissues will be stored for future studies.