MRI Biomarkers in ALS

NCT02405182 | Completed

• 1 other identifier: RES0013831
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis; ALS; Motor Neuron Diseases

Keywords

Magnetic Resonance Imaging; MRI; Biomarker

Outcome Measures

Primary Outcomes (1)

• Change in neuronal and white matter integrity measures.

  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 Outcomes (1)

• Correlation of neuronal and white matter integrity measures with clinical indices.

  30 months

Study Arms (2)

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: Magnetic Resonance Imaging

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: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging OTHER

Also known as: MRI

Controls; Patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator
• Western University, Canada: collaborator
• McGill University: collaborator
• University of Toronto: collaborator

Study Sites (6)

University of Calgary / Heritage Medical Research Clinic

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

University of British Columbia / GF Strong Rehab Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Western University / London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

University of Toronto / Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

McGill University / Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

Related Publications (2)

• Ta D, Ishaque A, Srivastava O, Hanstock C, Seres P, Eurich DT, Luk C, Briemberg H, Frayne R, Genge AL, Graham SJ, Korngut L, Zinman L, Kalra S. Progressive Neurochemical Abnormalities in Cognitive and Motor Subgroups of Amyotrophic Lateral Sclerosis: A Prospective Multicenter Study. Neurology. 2021 Aug 24;97(8):e803-e813. doi: 10.1212/WNL.0000000000012367. Epub 2021 Jun 14.

  PMID: 34426551 DERIVED

• Kalra S, Muller HP, Ishaque A, Zinman L, Korngut L, Genge A, Beaulieu C, Frayne R, Graham SJ, Kassubek J. A prospective harmonized multicenter DTI study of cerebral white matter degeneration in ALS. Neurology. 2020 Aug 25;95(8):e943-e952. doi: 10.1212/WNL.0000000000010235. Epub 2020 Jul 9.

  PMID: 32646955 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sanjay Kalra, MD, FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: April 1, 2015
• Study Start: September 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

CA (6)