Health Trialsby

Multicenter ALS Imaging Study

ConditionsAmyotrophic Lateral Sclerosis ALS

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

< 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

Disqualifiers

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.

Trial population

Adults with early-stage ALS

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Magnetic Resonance Imaging
Diagnostic test
Participants will undergo 3T MRI scanning of the brain and cervical spine MRIs
Plasma neurofilament light chain (NfL) quantification
Diagnostic test
Participants will undergo a blood draw for the quantification of plasma neurofilament light chain

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Participants with ALS2 interventions

Group B: Participants without ALS2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame

Baseline, 3 months, 6 months, 12 months

2

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.

Time frame

Baseline, 3 months, 6 months, 12 months

3

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.

Time frame

Baseline, 3 months, 6 months, 12 months

4

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.

Time frame

Baseline, 3 months, 6 months, 12 months

Secondary outcomes

1

Plasma neurofilament light (NfL) quantification

Plasma NfL quantification will be reported in units of pg/ml.

Time frame

Baseline, 3 months, 6 months, 12 months

2

ALS Functional Rating Scale, Revised (ALSFRS-R)

The ALSFRS-R includes 12 questions. Each task is rated on a five-point scale from 0 (can't do) to 4 (normal ability). Individual item scores are summed to produce a reported score of between 0=worst and 48=best.

Time frame

Baseline, 3 months, 6 months, 12 months

3

Edinburgh Cognitive and Behavioural Screen (ECAS)

The ECAS is a 20-minute assessment of language, memory, verbal fluency, executive function, visuospatial function, and social cognition, which produce a number of subscales with a maximum total score of 136. Higher scores indicate better functioning.

Time frame

At 3-month visit (optional)

4

Penn Upper Motor Neuron Score

The Penn Upper Motor Neuron Score (PUMNS) is a 28-item scale that measures upper motor neuron (UMN) signs in amyotrophic lateral sclerosis (ALS). The scale ranges from 0 (normal) to 32 (for widespread/severe UMN involvement) and evaluates the bulbar region (scores 0-4), upper limbs (scores 0-14), and lower limb (scores 0-14). Higher scores indicate greater disease burden.

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Food and Drug Administration (FDA)

Collaborator

Minnesota Office of Higher Education

Collaborator

Source ClinicalTrials.gov