NCT06735014 · University of Minnesota
Multicenter ALS Imaging Study
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Magnetic Resonance Imaging
Participants will undergo 3T MRI scanning of the brain and cervical spine MRIs
DIAGNOSTIC_TEST
Plasma neurofilament light chain (NfL) quantification
Participants will undergo a blood draw for the quantification of plasma neurofilament light chain
Primary outcome measures
Fiber Density
Time frame: Baseline, 3 months, 6 months, 12 months
This measure comes from the biophysical model used in brain imaging and is collected using MRI. It refers to the volume of the intra-axonal compartment per unit volume of the tissue. As this is a fraction it does not have a unit.
Fiber Cross-Section
Time frame: Baseline, 3 months, 6 months, 12 months
This measure comes from the biophysical model used in brain imaging and is collected using MRI. It refers to the change it fiber cross-section at the fiber bundle level when undergoing spatial normalization. This measure does not have a unit.
Orientation Dispersion
Time frame: Baseline, 3 months, 6 months, 12 months
This measure comes from the biophysical model used in brain imaging and is collected using MRI. Orientation dispersion is a measure of the uncertainty in the estimation of the fiber bundle orientation. It varies from 0 to 1 and does not have a unit. Higher values indicate greater uncertainty in estimation.
Intracellular Volume Fraction
Time frame: Baseline, 3 months, 6 months, 12 months
This measure comes from the biophysical model used in brain imaging and is collected using MRI. It is the proportion of the imaging voxel occupied by intracellular compartments. This ratio varies from 0 to 1 and does not have a unit. Larger values indicate greater density of intracellular compartments.
Free Water
Time frame: Baseline, 3 months, 6 months, 12 months
This measure comes from the biophysical model used in brain imaging and is collected using MRI. It represents the fractional volume of the free-water compartment. This is a ratio and it does not have a unit.
Cortical Thickness
Time frame: Baseline, 3 months, 6 months, 12 months
This measure is collected using MRI. It is the thickness of the cortical gray matter and is measured in millimeters.
Spinal Cord Cross-Sectional Area
Time frame: Baseline, 3 months, 6 months, 12 months
This measure is collected using MRI. It is the area of the spinal cord cross-section measured in millimeter square.
Spinal Cord Corticospinal Tract (CST) Fractional Anisotropy (FA)
Time frame: Baseline, 3 months, 6 months, 12 months
This measure is collected using MRI. It is a dimensionless scalar value between 0 and 1, indicating the degree of anisotropy (directionality) of water diffusion in the spinal cord's corticospinal tract. Higher values indicate higher anisotropy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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.
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
- Gainesville, Florida
- Evanston, Illinois
- Minneapolis, Minnesota
Collaborators
Food and Drug Administration (FDA), Minnesota Office of Higher Education
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations