Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors
Primary Purpose
Ischemic White Matter Disease, Transient Ischemic Attack, Mild Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Executive Function Training Program
Psychoeducational Training Program
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic White Matter Disease focused on measuring cognitive impairment, ischemic white matter disease, small vessel disease, transient ischemic attack, mild stroke, stroke risk
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
Sites / Locations
- BaycrestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Executive Function Training Program
Psychoeducational Training Program
Arm Description
Participants in this group will receive the novel intervention training.
Participants in this group will receive the control intervention training.
Outcomes
Primary Outcome Measures
Change from baseline in neuropsychological test performance at post-intervention
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
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
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
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.
Full Information
NCT ID
NCT01951612
First Posted
September 24, 2013
Last Updated
July 18, 2016
Sponsor
Baycrest
Collaborators
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01951612
Brief Title
Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors
Official Title
Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baycrest
Collaborators
Sunnybrook Health Sciences Centre
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic White Matter Disease, Transient Ischemic Attack, Mild Stroke, Stroke Risk
Keywords
cognitive impairment, ischemic white matter disease, small vessel disease, transient ischemic attack, mild stroke, stroke risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Executive Function Training Program
Arm Type
Experimental
Arm Description
Participants in this group will receive the novel intervention training.
Arm Title
Psychoeducational Training Program
Arm Type
Active Comparator
Arm Description
Participants in this group will receive the control intervention training.
Intervention Type
Behavioral
Intervention Name(s)
Executive Function Training Program
Intervention Description
Participants will take part in ten 2-hour sessions over 5 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational Training Program
Intervention Description
Participants will take part in ten 2-hour sessions over 5 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in neuropsychological test performance at post-intervention
Description
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.
Time Frame
Baseline and post-intervention at 10 weeks
Title
Change from baseline in neuropsychological test performance at 2 month follow-up
Description
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.
Time Frame
Baseline and follow-up at 2 months
Secondary Outcome Measure Information:
Title
Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention
Description
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.
Time Frame
Baseline and post-intervention at 10 weeks
Title
Change from baseline in neuroimaging (fMRI/EEG) markers at 2 month follow-up
Description
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.
Time Frame
Baseline and follow-up at 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Levine, PhD
Phone
416-785-2500
Ext
3593
Email
blevine@research.baycrest.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nivethika Jeyakumar, BSc
Phone
416-785-2500
Ext
3104
Email
njeyakumar@research.baycrest.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Levine, PhD
Organizational Affiliation
Rotman Research Institute, Baycrest
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Turner, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Black, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baycrest
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Levine, PhD
Phone
416-785-2500
Ext
3593
Email
blevine@research.baycrest.org
First Name & Middle Initial & Last Name & Degree
Nivethika Jeyakumar, BSc
Phone
416-785-2500
Ext
3104
Email
njeyakumar@research.baycrest.org
First Name & Middle Initial & Last Name & Degree
Brian Levine, PhD
12. IPD Sharing Statement
Learn more about this trial
Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors
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