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| ID | Type | Description | Link |
|---|---|---|---|
| 232-2009 | Other Identifier | Sunnybrook Health Sciences Centre |
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| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Executive Function Training Program | Experimental | Participants in this group will receive the novel intervention training. |
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| Psychoeducational Training Program | Active Comparator | Participants in this group will receive the control intervention training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Executive Function Training Program | Behavioral | Participants will take part in ten 2-hour sessions over 5 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and post-intervention at 10 weeks |
| 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. | Baseline and follow-up at 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and post-intervention at 10 weeks |
| Change from baseline in neuroimaging (fMRI/EEG) markers at 2 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Levine, PhD | Contact | 416-785-2500 | 3593 | blevine@research.baycrest.org |
| Nivethika Jeyakumar, BSc | Contact | 416-785-2500 | 3104 | njeyakumar@research.baycrest.org |
| Name | Affiliation | Role |
|---|---|---|
| Brian Levine, PhD | Rotman Research Institute, Baycrest | Principal Investigator |
| Gary Turner, PhD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baycrest | Recruiting | Toronto | Ontario | M6A 2E1 | Canada |
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| Psychoeducational Training Program | Behavioral | Participants will take part in ten 2-hour sessions over 5 weeks. |
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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. |
| Baseline and follow-up at 2 months |
| Sandra Black, MD |
| Sunnybrook Health Sciences Centre |
| Principal Investigator |
| ID | Term |
|---|---|
| D002546 | Ischemic Attack, Transient |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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