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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Executive Function Training Program Behavioral
    Intervention Desc: Participants will take part in ten 2-hour sessions over 5 weeks.
    ARM 1: Kind: Experimental
    Label: Executive Function Training Program
    Description: Participants in this group will receive the novel intervention training.
  • Psychoeducational Training Program Behavioral
    Intervention Desc: Participants will take part in ten 2-hour sessions over 5 weeks.
    ARM 1: Kind: Experimental
    Label: Psychoeducational Training Program
    Description: Participants in this group will receive the control intervention training.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in neuropsychological test performance at post-intervention Baseline and post-intervention at 10 weeks No
Primary Change from baseline in neuropsychological test performance at 2 month follow-up Baseline and follow-up at 2 months No
Secondary Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention Baseline and post-intervention at 10 weeks No
Secondary Change from baseline in neuroimaging (fMRI/EEG) markers at 2 month follow-up Baseline and follow-up at 2 months No

Sponsors