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

Not Applicable

• Conditions: Transient Ischemic Attack; Stroke Risk; Mild Stroke; Ischemic White Matter Disease
• Interventions: Behavioral: Executive Function Training Program; Behavioral: Psychoeducational Training Program

• Registration Number: NCT01951612
• Lead Sponsor: Baycrest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-26
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-20
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Executive Function Training Program	Executive Function Training Program	Participants in this group will receive the novel intervention training.
Psychoeducational Training Program	Psychoeducational Training Program	Participants in this group will receive the control intervention training.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Baycrest; 🇨🇦 Toronto, Ontario, Canada