Multicenter study using MRI to identify biomarkers in ALS patients
Multicenter Longitudinal Imaging in ALS for Disease Biomarker Development
This study is trying to see if brain scans and blood tests can help track how ALS changes over time in patients compared to healthy people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 3 sites (Gainesville, Florida and 2 other locations) |
| Trial ID | NCT06735014 on ClinicalTrials.gov |
What this trial studies
This observational study involves participants with Amyotrophic Lateral Sclerosis (ALS) and healthy controls who will undergo brain and cervical spine MRIs along with blood tests for neurofilament light chains at multiple time points over a year. The primary aim is to identify objective biomarkers that can effectively track disease progression in ALS. By utilizing advanced MRI techniques and combining various imaging metrics, the study seeks to enhance the sensitivity of detecting changes in the central nervous system associated with ALS. The findings could lead to improved diagnostic accuracy and better understanding of disease dynamics.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with ALS within the last 24 months who meet specific clinical criteria and have a forced vital capacity of at least 60%.
Not a fit: Patients with conditions that contraindicate MRI or those unable to comply with study protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical biomarkers for monitoring ALS progression, leading to more effective treatment strategies.
How similar studies have performed: Previous studies have shown promise in using MRI metrics to detect changes in ALS, suggesting that this multimodal approach may build on existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Criteria: * 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.
Where this trial is running
Gainesville, Florida and 2 other locations
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Northwestern University — Evanston, Illinois, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Pramod Pisharady, PhD — University of Minnesota
- Study coordinator: Melisa Bailey, MS
- Email: baile807@umn.edu
- Phone: 612-624-4911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.