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Active, not recruitingNCT03362658Updated May 8, 2026

Novel MRI Biomarkers for Monitoring Disease Progression in ALS

An observational study in Amyotrophic Lateral Sclerosis and Motor Neuron Disease, sponsored by University of Alberta. Active, not recruiting at 7 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by University of Alberta · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
119
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 82 studies in Amyotrophic Lateral Sclerosis with a site in Canada — 15 open to participants now, 25 under way, 5 of them phase 3. Amyotrophic Lateral Sclerosis · Canada.

Enrollment
8th of 10
119 · median 148
Started
2016
with 5 others
Observational
10 of 82
2 open now
Primary completion
2023-12
later than 0 of 24 live
Registered
30th of 82
by date
Lead sponsor
5 of 82
University of Alberta

Among the 82 studies in Amyotrophic Lateral Sclerosis with a site in Canada, this one is the 8th largest by enrollment of the 10 observational ones that give a count, is one of 6 that started in 2016, is one of 10 observational ones, reaches primary completion later than 0 of the 24 other live ones, and was the 30th registered.

Amyotrophic Lateral Sclerosis

979 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 278 are open to participants now.

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Open to participants now

15 of the 82 studies in Amyotrophic Lateral Sclerosis with a site in Canada are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 193 Amyotrophic Lateral Sclerosis studies recruiting now, 118 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study summary

Routine MRI is normal in motor neuron diseases such as ALS. However, advanced MRI techniques can provide an objective measure of degeneration (a "biomarker") by examining brain structure, wiring, chemistry, and function. We will develop and evaluate novel MRI techniques that could improve our understanding of ALS and provide a means to diagnose it sooner and monitor its progression. Importantly, we expect these techniques to improve how new drugs are tested, which may lead to the more rapid discovery of a treatment for ALS.

Each participant will have 3 MRI scans over a period of 8 months, along with neurological and cognitive evaluations. Study visits will take 2 - 3 hours. MRI is a safe technique that does not involve radiation.

Read the detailed description

Current clinical measures of disease burden have suboptimal sensitivity to disease progression in ALS. A biomarker would play an essential role in the evaluation of novel therapeutics, leading to the realization of effective treatments faster. Magnetic resonance imaging (MRI) holds promise as a non-invasive source of biomarkers in ALS. In this study data is collected from a national imaging platform (the Canadian ALS Neuroimaging Consortium [CALSNIC]) using standardized MRI and clinical protocols.

CALSNIC was founded with the objective to validate MRI biomarkers on a standardized multi-centre platform. CALSNIC is a multidisciplinary group of scientists at 7 centres across Canada. The first CALSNIC study entitled "MRI Biomarkers in ALS" (CALSNIC-1) is ongoing and slated to finish recruitment in 2017.

This study ("Novel MRI Biomarkers for Monitoring Disease Progression in ALS", CALSNIC-2) is a new project that will evaluate novel MRI biomarkers using advanced imaging acquisition and processing methods. The specific aims of CALSNIC-2 are 1) to establish a standardized MRI and clinical protocol across the 7 centres, and 2) to validate MRI measures with clinical measures of disease burden and progression.

It is anticipated that the project will lead to the discovery of MR-based biomarkers of cerebral degeneration that can be applied across different centres and hence, can assist with drug development. Secondly, this project will expand CALSNIC to include more centres and provide opportunities for collaborative and multidisciplinary translational research on a national scale.

03

Conditions studied

  • Amyotrophic Lateral Sclerosis
  • Motor Neuron Disease

Keywords

  • Magnetic Resonance Imaging
  • MRI
  • Biomarker
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

  1. Patients with a diagnosis of motor neuron disease (MND). This includes the diagnoses of amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA).
  2. Patients with frontotemporal dementia (FTD) with or without motor neuron signs.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with a suspected or confirmed diagnosis as described in Study Populations
  • For those with a diagnosis of ALS, patients will be considered with an El Escorial classification of suspected, possible, probable, probable lab-supported, and definite ALS.
  • Patients 18 years of age or older
  • Healthy controls over the age of 40.
  • Be able to lie in an MRI machine for approximately 60 minutes

Exclusion criteria

Exclusion Criteria:

  • Subjects with psychiatric/CNS illnesses such as Major Depressive Disorder, Schizophrenia, and Bipolar disorder.
  • Subjects with significant head injury or other neurological disease (stroke, brain tumour).
  • Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
119 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

    ALS patients (as well as patients with other related disorders such PLS, PMA, and ALS-FTD) will be recruited from ALS clinics under the direction of neurologists who are participating in this study. ALS patients should meet research criteria for suspected, possible, probable, probable laboratory supported, or definite ALS.

  • Controls

    Healthy controls who are age and gender matched to patients.

06

What researchers measure

Primary outcomes

  1. Change in cortical thickness in millimetres.

    This primary analysis will evaluate neuronal integrity at baseline and specified follow up periods. Patients and controls scans will be compared.

    Time frame: 8 months

  2. Change in DTI indices (unitless).

    This primary analysis will evaluate white matter integrity at baseline and specified follow up periods. Patients and controls scans will be compared.

    Time frame: 8 months

07

Study locations

7 sites
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2016, a primary completion of Dec 2023 and a completion of Dec 2026. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2017
First posted
Dec 5, 2017
Start
Oct 2016
Primary completionActual
Dec 31, 2023
CompletionEst.
Dec 31, 2026
Last update
May 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03362658
Responsible party
Sponsor
First posted
Dec 5, 2017
Start date
Oct 2016
Primary completion
Dec 31, 2023
Completion
Dec 31, 2026 (estimated)
Last update
May 8, 2026

Study contacts

Sanjay Kalra, MD
principal investigator · FRCPC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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