Recruiting

ALS Imaging

Sponsor:

University of Minnesota

Code:

NCT06735014

Conditions

Amyotrophic Lateral Sclerosis

ALS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Imaging

Plasma neurofilament light chain (NfL) quantification

Study Details

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

Study ID

NCT06735014

Start date

Sep 15, 2024

Status verified date

May, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with ALS

Adults with early stage ALS

Participants without ALS

Control participants free from neurological disease

Interventions

Magnetic Resonance Imaging

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

Plasma neurofilament light chain (NfL) quantification

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

Primary outcome measure

  • Fiber Density [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
  • Fiber Cross-Section [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
  • Orientation Dispersion [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
  • Intracellular Volume Fraction [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
  • Free Water [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
  • Cortical Thickness [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
  • Spinal Cord Cross-Sectional Area [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
  • Spinal Cord Corticospinal Tract (CST) Fractional Anisotropy (FA) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]

Central Contacts and Locations

Central contacts

Melisa Bailey, MS

612-624-4911baile807@umn.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Principal Investigator:

James Wymer, MD, FAAN

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Principal Investigator:

Senda Ajroud-Driss, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Melisa Bailey, MS

baile807@umn.edu

Principal Investigator:

David Walk, MD

More Information

Sponsor

University of Minnesota

Last update posted

Jul 31, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-07-31.