MRI Biomarkers in ALS

December 4, 2020 updated by: Sanjay Kalra, University of Alberta

Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative disorder. There is no treatment that significantly slows progression. Increasing age is an important risk factor for developing ALS; thus, the societal impact of this devastating disease will become more profound as the population ages. A significant hurdle to finding effective treatment has been an inability to accurately measure brain degeneration in humans. Advanced magnetic resonance imaging (MRI) techniques hold promise in this respect, and may assist in aiding diagnosis and the efficient testing of new drugs.

Different MRI features of brain degeneration will be measured in a large sample of patients with ALS. The study will operate within the Canadian ALS Neuroimaging Consortium (CALSNIC). CALSNIC is a clinical research platform comprised of ALS clinics with standardized clinical and neuroimaging protocols.

Study Overview

Detailed Description

This study will use advanced Magnetic Resonance Imaging (MRI) techniques to measure brain changes in ALS and related neurological conditions. Results from cognitive and neurological tests will be compared to the MRI. It is believed that these techniques will reveal changes in the brain that will help us understand normal brain function and the symptoms of neurological diseases as seen in ALS, as well to provide an objective measurement of degeneration (which is called a biomarker). This could improve not only the process by which new drugs for the treatment of neurological diseases are evaluated, but also how health care professionals address the needs of patients with these diseases.

Furthermore, a biomarker may give insight into the biological factors related to the diverse and variable clinical features amongst different patients.

Subjects will be recruited from ALS clinics that are a part of the Canadian ALS Neuroimaging Consortium (CALSNIC). Patients will have a diagnosis of ALS, PLS, PMA, or FTD. Healthy controls will be age and gender matched to patients. Subjects will visit their respective sites to undergo a clinical evaluation and an MRI. Follow up visits will occur at approximately 3-6 month intervals. Most subjects will have 2 follow up visits; more visits may occur for subjects who are physically able to continue in the protocol.

Study Type

Observational

Enrollment (Actual)

145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary / Heritage Medical Research Clinic
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2G9
        • University of British Columbia / GF Strong Rehab Centre
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Western University / London Health Sciences Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • University of Toronto / Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • McGill University / Montreal Neurological Institute and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited predominantly from ALS clinics at: the University of Alberta Hospital in Edmonton; the Foothills Medical Centre in Calgary; the Sunnybrook Health Sciences Centre in Toronto; the London Health Sciences Centre in London; and the Montreal Neurological Hospital in Montreal.

Description

Inclusion Criteria:

  • Patients will be adults with a diagnosis of motor neuron disease (MND), including those with ALS, PLS, and PMA, and as well frontotemporal dementia (FTD) without motor neuron signs.
  • Healthy controls over the age of 40 will also be recruited and will be age- and gender-matched to patients.

Exclusion Criteria:

  • Subjects with other psychiatric/CNS illnesses such as Major Depressive Disorder, Schizophrenia, and Bipolar disorder, and those with significant head injury.
  • Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body, or significant claustrophobia that could affect the ability to have an MRI scan.

These exclusion criteria will also apply to controls.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
ALS patients (as well as patients with other motor neuron diseases such PLS and PMA) will be recruited from ALS clinics under the direction of ALS neurologists who are participating in this study. ALS patients should meet research criteria for possible, probable, probable laboratory-supported, or definite ALS. Patients with a history of CNS disease (e.g. stroke, head injury) or significant psychiatric disease will be ineligible. Patients must be able to undergo a brain MRI for approximately an hour.
Other Names:
  • MRI
Controls
Healthy controls who are age and gender matched to patients will be recruited. Controls with a history of CNS disease (e.g. stroke, head injury) or significant psychiatric disease will be ineligible. Controls must be able to undergo a brain MRI for approximately an hour.
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in neuronal and white matter integrity measures.
Time Frame: 24 months
The primary analysis will evaluate changes in the brain using various advanced MRI techniques at baseline and specified follow up periods. Patients and controls scans will be compared.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of neuronal and white matter integrity measures with clinical indices.
Time Frame: 30 months
Secondary analyses will involve MRI comparison to clinical measures both at the time of the baseline scan and over time.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sanjay Kalra, MD, FRCPC, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

December 7, 2020

Last Update Submitted That Met QC Criteria

December 4, 2020

Last Verified

December 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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