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

Study Overview
=================
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.

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

Conditions
-----------------
Ischemic White Matter Disease, Transient Ischemic Attack, Mild Stroke, Stroke Risk

Intervention / Treatment
-----------------
* Behavioral: Executive Function Training Program
* Behavioral: Psychoeducational Training Program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Executive Function Training Program<br>Participants in this group will receive the novel intervention training. | Behavioral: Executive Function Training Program<br>* Participants will take part in ten 2-hour sessions over 5 weeks.<br>|
| Active Comparator: Psychoeducational Training Program<br>Participants in this group will receive the control intervention training. | Behavioral: Psychoeducational Training Program<br>* Participants will take part in ten 2-hour sessions over 5 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive impairment, ischemic white matter disease, small vessel disease, transient ischemic attack, mild stroke, stroke risk