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Novel MRI Biomarkers for Monitoring Disease Progression in ALS
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.
Conditions:
🦠 Amyotrophic Lateral Sclerosis 🦠 Motor Neuron Disease
🗓️ Study Start (Actual) October 2016
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 700
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Miami, Florida, United States
📍 Salt Lake City, Utah, United States
📍 Calgary, Alberta, Canada
📍 Edmonton, Alberta, Canada
📍 Vancouver, British Columbia, Canada
📍 London, Ontario, Canada
📍 Toronto, Ontario, Canada
📍 Montreal, Quebec, Canada
📍 Quebec City, Quebec, Canada
More locations available...

📋 Eligibility Criteria

Description

    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:

    • * 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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 Registration Dates

  • First Submitted 18 October 2017
  • First Submitted that Met QC Criteria 29 November 2017
  • First Posted 5 December 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 February 2024
  • Last Update Posted 20 February 2024
  • Last Verified February 2024
I'm interested ...!!