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

N/AUnknownNCT01951612

Baycrest40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ischemic White Matter Disease Transient Ischemic Attack

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline and post-intervention at 10 weeks

Change from baseline in neuropsychological test performance at 2 month follow-up

Time frame: Baseline and follow-up at 2 months

Secondary Outcomes

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.

Time frame: 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.