Ischemic White Matter Disease, Mild Stroke, Stroke Risk, Transient Ischemic Attack
Conditions
Keywords
cognitive impairment, ischemic white matter disease, small vessel disease, transient ischemic attack, mild stroke, stroke risk
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.
Interventions
BEHAVIORALExecutive Function Training Program
Participants will take part in ten 2-hour sessions over 5 weeks.
BEHAVIORALPsychoeducational Training Program
Participants will take part in ten 2-hour sessions over 5 weeks.
Sponsors
Sunnybrook Health Sciences Centre
Baycrest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in neuropsychological test performance at post-intervention | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention | 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 | 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. |
Countries
Canada
Contacts
Primary ContactBrian Levine, PhD
Backup ContactNivethika Jeyakumar, BSc
Outcome results
None listed