Multicenter ALS Imaging Study

NCT06735014 | Recruiting

• 1 other identifier: CMRR-2024-32796
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis; ALS

Keywords

Magnetic Resonance Imaging; MRI; ALSFRS-R; ECAS; plasma neurofilament light; NfL

Outcome Measures

Primary Outcomes (8)

• Fiber Density

  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.

  Baseline, 3 months, 6 months, 12 months

• Fiber Cross-Section

  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.

  Baseline, 3 months, 6 months, 12 months

• Orientation Dispersion

  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.

  Baseline, 3 months, 6 months, 12 months

• Intracellular Volume Fraction

  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.

  Baseline, 3 months, 6 months, 12 months

• Free Water

  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.

  Baseline, 3 months, 6 months, 12 months

• Cortical Thickness

  This measure is collected using MRI. It is the thickness of the cortical gray matter and is measured in millimeters.

  Baseline, 3 months, 6 months, 12 months

• Spinal Cord Cross-Sectional Area

  This measure is collected using MRI. It is the area of the spinal cord cross-section measured in millimeter square.

  Baseline, 3 months, 6 months, 12 months

• Spinal Cord Corticospinal Tract (CST) Fractional Anisotropy (FA)

  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.

  Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (4)

• Plasma neurofilament light (NfL) quantification

  Baseline, 3 months, 6 months, 12 months

• ALS Functional Rating Scale, Revised (ALSFRS-R)

  Baseline, 3 months, 6 months, 12 months

• Edinburgh Cognitive and Behavioural Screen (ECAS)

  At 3-month visit (optional)

• Penn Upper Motor Neuron Score

  Baseline

Study Arms (2)

Participants with ALS

Adults with early stage ALS

Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Plasma neurofilament light chain (NfL) quantification

Participants without ALS

Control participants free from neurological disease

Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Plasma neurofilament light chain (NfL) quantification

Interventions

Magnetic Resonance Imaging DIAGNOSTIC_TEST

Participants will undergo 3T MRI scanning of the brain and cervical spine MRIs

Participants with ALS; Participants without ALS

Plasma neurofilament light chain (NfL) quantification DIAGNOSTIC_TEST

Participants will undergo a blood draw for the quantification of plasma neurofilament light chain

Participants with ALS; Participants without ALS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with early-stage ALS

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• Food and Drug Administration (FDA): collaborator
• Minnesota Office of Higher Education: collaborator

Study Sites (3)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

Northwestern University

Evanston, Illinois, 60208, United States

NOT YET RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Pramod Pisharady, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melisa Bailey, MS

CONTACT

612-624-4911; baile807@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 16, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (3)