Multicenter study using MRI to identify biomarkers in ALS patients
Official title: Multicenter Longitudinal Imaging in ALS for Disease Biomarker Development
Run by University of Minnesota · NCT06735014 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of Minnesota Academic / other |
| Locations | 3 sites (Gainesville, Florida and 2 other locations) |
| Status | Recruiting |
| Started | September 15, 2024 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2028 |
| Registry record updated | July 31, 2026 |
| Trial ID | NCT06735014 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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%.
✕Probably not a fit
Patients with conditions that contraindicate MRI or those unable to comply with study protocols may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promise in using MRI metrics to detect changes in ALS, suggesting that this multimodal approach may build on existing knowledge.
Who can join: the full rules
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 OR meets Gold Coast 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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Biobank for studying ALS and Alzheimer's diseases
This study is collecting blood, skin samples, and health information from people to see how genetics might help us understand and find treatments for ALS and Alzheimer's disease.
-
Treatment for neurologic disorders using stem cells
This study is testing whether using stem cells from patients' own bone marrow can help improve brain and nerve function in people with serious neurologic disorders that don't respond well to regular treatments.
-
Implanted Brain-Computer Interface to Help People with Severe Arm Impairment
We’re testing the N1 System, a fully implanted brain interface in the motor cortex with a robot, to see if it can help adults with spinal cord injury, ALS, or chronic stroke use a computer or keyboard more easily.
-
Brain-computer interface chat tool for people with ALS
This test compares a wearable brain-computer interface communication device to eye-tracking devices that people with ALS currently use to help them communicate.
-
BIIB147 safety and how it behaves in adults with ALS
This study tests BIIB147 in adults with ALS to see if it is safe and how the body handles it, including early and long-term effects.
-
Aims to restore UNC13A function in people with ALS
This trial tests TRCN-1023 in adults with ALS to see if it’s safe, tolerated, and shows early signs of benefit.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.