Regional Cortical Cerebral Quantitative MRI Perfusion Correlation Neurocognition in Multiple Sclerosis

November 16, 2015 updated by: Dr. Richard Aviv, Sunnybrook Health Sciences Centre
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

60

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Secondary progressive Multiple sclerosis

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive Impairment
Time Frame: Cognitive impairment is assessed on the same day as the MRI scan
Cognitive impairment is assessed on the same day as the MRI scan

Collaborators and Investigators

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

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Unity Health Toronto
The Physicians' Services Incorporated Foundation

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

December 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 373-2007

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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