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

This study is currently recruiting participants.
Verified July 2016 by Brian Levine, Baycrest
Sponsor:
ClinicalTrials.gov Identifier:
NCT01951612
First Posted: September 26, 2013
Last Update Posted: July 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Brian Levine, Baycrest
September 24, 2013
September 26, 2013
July 20, 2016
November 2011
December 2016   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01951612 on ClinicalTrials.gov Archive Site
  • Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention [ Time Frame: Baseline and post-intervention at 10 weeks ]
    Measurement of fMRI and EEG signal changes at post-intervention (10 weeks) will be used. Measures of brain activation and network function will be used as secondary outcome measures.
  • Change from baseline in neuroimaging (fMRI/EEG) markers at 2 month follow-up [ Time Frame: Baseline and follow-up at 2 months ]
    Measurement of fMRI and EEG signal changes at follow-up (2 months) will be used. Measures of brain activation and network function will be used as secondary outcome measures.
Same as current
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Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors
Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Ischemic White Matter Disease
  • Transient Ischemic Attack
  • Mild Stroke
  • Stroke Risk
  • Behavioral: Executive Function Training Program
    Participants will take part in ten 2-hour sessions over 5 weeks.
  • Behavioral: Psychoeducational Training Program
    Participants will take part in ten 2-hour sessions over 5 weeks.
  • Experimental: Executive Function Training Program
    Participants in this group will receive the novel intervention training.
    Intervention: Behavioral: Executive Function Training Program
  • Active Comparator: Psychoeducational Training Program
    Participants in this group will receive the control intervention training.
    Intervention: Behavioral: Psychoeducational Training Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Brian Levine, PhD 416-785-2500 ext 3593 blevine@research.baycrest.org
Contact: Nivethika Jeyakumar, BSc 416-785-2500 ext 3104 njeyakumar@research.baycrest.org
Canada
 
 
NCT01951612
08-53
232-2009 ( Other Identifier: Sunnybrook Health Sciences Centre )
Not Provided
Not Provided
Not Provided
Brian Levine, Baycrest
Baycrest
Sunnybrook Health Sciences Centre
Principal Investigator: Brian Levine, PhD Rotman Research Institute, Baycrest
Principal Investigator: Gary Turner, PhD Sunnybrook Health Sciences Centre
Principal Investigator: Sandra Black, MD Sunnybrook Health Sciences Centre
Baycrest
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP