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

This study is currently recruiting participants.
Verified September 2013 by Baycrest
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Brian Levine, Baycrest
ClinicalTrials.gov Identifier:
NCT01951612
First received: September 24, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Ischemic White Matter Disease
Transient Ischemic Attack
Mild Stroke
Stroke Risk
Behavioral: Executive Function Training Program
Behavioral: Psychoeducational Training Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors

Resource links provided by NLM:


Further study details as provided by Baycrest:

Primary Outcome Measures:
  • Change from baseline in neuropsychological test performance at post-intervention [ Time Frame: Baseline and post-intervention at 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention [ Time Frame: Baseline and post-intervention at 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Executive Function Training Program
Participants in this group will receive the novel intervention training.
Behavioral: Executive Function Training Program
Participants will take part in ten 2-hour sessions over 5 weeks.
Active Comparator: Psychoeducational Training Program
Participants in this group will receive the control intervention training.
Behavioral: Psychoeducational Training Program
Participants will take part in ten 2-hour sessions over 5 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01951612

Contacts
Contact: Brian Levine, PhD 416-785-2500 ext 3593 blevine@research.baycrest.org
Contact: Aggie Bacopulos, BSc 416-785-2500 ext 3100 abacopulos@research.baycrest.org

Locations
Canada, Ontario
Baycrest Recruiting
Toronto, Ontario, Canada, M6A 2E1
Contact: Brian Levine, PhD    416-785-2500 ext 3593    blevine@research.baycrest.org   
Contact: Aggie Bacopulos, BSc    416-785-2500 ext 3100    abacopulos@research.baycrest.org   
Principal Investigator: Brian Levine, PhD         
Sponsors and Collaborators
Baycrest
Sunnybrook Health Sciences Centre
Investigators
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
  More Information

No publications provided

Responsible Party: Brian Levine, Senior Scientist, Baycrest
ClinicalTrials.gov Identifier: NCT01951612     History of Changes
Other Study ID Numbers: 08-53, 232-2009
Study First Received: September 24, 2013
Last Updated: September 24, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Baycrest:
cognitive impairment
ischemic white matter disease
small vessel disease
transient ischemic attack
mild stroke
stroke risk

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
Cerebral Infarction
Leukoencephalopathies
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction

ClinicalTrials.gov processed this record on April 17, 2014