Regional Cortical Cerebral Quantitative MRI Perfusion Correlation Neurocognition in Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Dr. Richard Aviv, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00812474
First received: December 19, 2008
Last updated: November 16, 2015
Last verified: November 2015
  Purpose
Multiple Sclerosis (MS) is a common disease affecting 1/1000 Canadians. Cognition impairment is reported in 40-65% of patients and is socially and functionally disabling. Although multiple sclerosis is widely regarded as a white matter disease, cortical disease burden is increasingly emphasized. Studies confirm that gray matter (GM) disease is grossly underestimated by conventional MRI. Although the cause for MS is unknown vascular impairment is implicated in nerve cell death. Several studies have shown perfusion abnormalities in the central GM and white matter (WM) structure. Severity of perfusion reduction correlates with lesion load, atrophy, MS subtype and disease duration. Further extent of cortical atrophy correlates with neurocognitive impairment. We hypothesize that cortical perfusion is a marker of cortical disease severity and correlates with neurocognitive impairment. To show this we will measure regional cortical perfusion and regional brain and WM lesion volumes in 26 predefined brain regions using a template developed for Alzheimer's disease. Regional perfusion will be correlated with neurocognitive tests validated for MS use. Patients will be divided into impaired and non impaired and perfusion compared controlling for known confounding factors. If confirmed cortical perfusion may be utilized as a surrogate marker of cognitive outcome in therapeutic studies.

Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Regional Cortical Cerebral Quantitative MRI Perfusion Correlation Neurocognition in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Cognitive Impairment [ Time Frame: Cognitive impairment is assessed on the same day as the MRI scan ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2008
Study Completion Date: November 2015
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:
We hypothesize that cortical perfusion is a marker of cortical disease severity and correlates with neurocognitive impairment. To show this we will measure regional cortical perfusion and regional brain and WM lesion volumes in 26 predefined brain regions using a template developed for Alzheimer's disease. Regional perfusion will be correlated with neurocognitive tests validated for MS use. Patients will be divided into impaired and non impaired and perfusion compared controlling for known confounding factors. If confirmed cortical perfusion may be utilized as a surrogate marker of cognitive outcome in therapeutic studies.
  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Secondary progressive Multiple sclerosis
Criteria

Inclusion Criteria:

  • established SPMS according to the McDonald criteria

Exclusion Criteria:

  • Patients with a history of drug/alcohol abuse, a premorbid (pre MS) psychiatric history, a head injury with loss of consciousness and a concurrent physical disease requiring medical attention (eg. cardiovascular disease etc), MRI contraindication including implants, pacemaker, aneurysm clips and known renal impairment
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Dr. Richard Aviv, PI, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00812474     History of Changes
Other Study ID Numbers: 373-2007 
Study First Received: December 19, 2008
Last Updated: November 16, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
cerebral blood flow

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 30, 2016