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CompletedNCT00812474Updated Nov 18, 2015

Regional Cortical Cerebral Quantitative MRI Perfusion Correlation Neurocognition in Multiple Sclerosis

An observational study in Multiple Sclerosis, sponsored by Sunnybrook Health Sciences Centre. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-11-18.

Sponsored by Sunnybrook Health Sciences Centre · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
16 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Multiple Sclerosis

Keywords

  • cerebral blood flow
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Secondary progressive Multiple sclerosis

Inclusion criteria

  • established SPMS according to the McDonald criteria

Exclusion 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
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What researchers measure

Primary outcomes

  1. Cognitive Impairment

    Time frame: Cognitive impairment is assessed on the same day as the MRI scan

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00812474
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborators
Unity Health Toronto, The Physicians' Services Incorporated Foundation
Responsible party
Dr. Richard Aviv (PI, Sunnybrook Health Sciences Centre) — Principal investigator
First posted
Dec 22, 2008
Start date
Dec 2008
Primary completion
Jun 2009
Completion
Nov 2015
Last update
Nov 18, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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