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Clinical Trials/NCT01951612
NCT01951612
Unknown
Not Applicable

Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors

Baycrest1 site in 1 country40 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic White Matter Disease
Sponsor
Baycrest
Enrollment
40
Locations
1
Primary Endpoint
Change from baseline in neuropsychological test performance at post-intervention
Last Updated
9 years ago

Overview

Brief Summary

Stroke is a leading cause of disability; most strokes (80%) are subcortical, with ischemic damage due to occlusion in penetrating arteries. Although ischemic white matter disease (iWMD) may lack gross clinical manifestation, it causes significant cognitive impairment, particularly on measures of executive function, attention, and memory. This impairment is attributable to diffuse damage affecting network connections.

While there are many studies concerning rehabilitation of motor function and language in patients with large focal strokes, few studies have addressed attentional and executive functions. To our knowledge, there are no such studies on iWMD. In this study, patients will be randomized to a novel intervention for improving executive function and a control condition matched for therapist exposure. Patients will be assessed pre-intervention, post-intervention, and at long-term follow-up using a battery of behavioural and neuroimaging tasks. We predict that the novel intervention will be associated with improved executive function, as assessed behaviourally, and improved frontal network function, as assessed through neuroimaging markers.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Baycrest
Responsible Party
Principal Investigator
Principal Investigator

Brian Levine

Senior Scientist

Baycrest

Eligibility Criteria

Inclusion Criteria

  • Patients with ischemic white matter disease or small vessel disease, who have experienced a transient ischemic attack, mild stroke, or are at risk of stroke
  • Fluent in English
  • Able to provide informed consent to all procedures
  • Sufficient motor and sensory functioning to complete all study components (with correction or assistance as required)

Exclusion Criteria

  • Substance abuse
  • Other psychiatric condition (other than mood, personality, or behaviour change following onset/diagnosis of white matter disease or related condition mentioned above)
  • Other medical condition suspected to influence cognition

Outcomes

Primary Outcomes

Change from baseline in neuropsychological test performance at post-intervention

Time Frame: Baseline and post-intervention at 10 weeks

Performance will be assessed using standardized neuropsychological tests of processing speed, attention, executive functions, visuospatial abilities, and learning and memory. A composite measure of executive functioning derived from principal components analysis will be used as the primary outcome measure.

Change from baseline in neuropsychological test performance at 2 month follow-up

Time Frame: Baseline and follow-up at 2 months

Performance will be assessed using standardized neuropsychological tests of processing speed, attention, executive functions, visuospatial abilities, and learning and memory. A composite measure of executive functioning derived from principal components analysis will be used as the primary outcome measure.

Secondary Outcomes

  • Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention(Baseline and post-intervention at 10 weeks)
  • Change from baseline in neuroimaging (fMRI/EEG) markers at 2 month follow-up(Baseline and follow-up at 2 months)

Study Sites (1)

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