Study Purpose:
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.
Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis , Motor Neuron Disease
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Sanjay Kalra, MD, FRCPC
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
University of Alberta
Sara Moradipoor, MSc / email hidden; JavaScript is required / 780-248-1805
Canada
Full Study Summary:
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.
Study Sponsor:
University of Alberta
Participant Duration:
8 months
Estimated Enrollment:
700
Estimated Study Start Date:
10 / 01 / 2016
Estimated Study Completion Date:
12 / 01 / 2023
Posting Last Modified Date:
01 / 26 / 2023
Date Study Added to neals.org:
12 / 05 / 2017
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
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.
University of Miami | Recruiting
Anna Thompson / 305-243-7613 / email hidden; JavaScript is required
Miami, Florida
United States
University of Utah | Recruiting
Robert Welsh / email hidden; JavaScript is required
Salt Lake City, Utah
84108
United States
University of Calgary / Heritage Medical Research Clinic | Recruiting
Victoria Hodgkinson / 403-210-7303 / email hidden; JavaScript is required
Janet Petrillo / 403-210-7006 / email hidden; JavaScript is required
Calgary, Alberta
T2N 4Z6
Canada
University of Alberta | Recruiting
Sara Moradipoor, MSc / 780-248-1805 / email hidden; JavaScript is required
Edmonton, Alberta
T6G 2B7
Canada
University of British Columbia / GF Strong Rehab Centre | Withdrawn
Vancouver, British Columbia
V5Z 2G9
Canada
Western University / London Health Sciences Centre | Withdrawn
London, Ontario
N6A 5A5
Canada
University of Toronto / Sunnybrook Health Sciences Centre | Recruiting
Shirley Pham / 416-480-5618 / email hidden; JavaScript is required
Toronto, Ontario
M4N 3M5
Canada
McGill University / Montreal Neurological Institute and Hospital | Recruiting
Natalie Saunders / 514-398-6526 / email hidden; JavaScript is required
Smita Patel / 514-398-1779 / email hidden; JavaScript is required
Montreal, Quebec
H3A 2B4
Canada
Laval University | Recruiting
Alexandra Simard, BSc / 418-649-0252 Ext. 63559 / email hidden; JavaScript is required
Quebec City, Quebec
G1V 0A6
Canada