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

Sponsor

Baycrest (Other)

Overall Status

Unknown status

CT.gov ID

NCT01951612

Collaborator

Sunnybrook Health Sciences Centre (Other)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic White Matter Disease Transient Ischemic Attack Mild Stroke Stroke Risk	Behavioral: Executive Function Training Program Behavioral: Psychoeducational Training Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Executive Function Training Program

Participants in this group will receive the novel intervention training.

Behavioral: Executive Function Training Program

Participants will take part in ten 2-hour sessions over 5 weeks.

Active Comparator: Psychoeducational Training Program

Participants in this group will receive the control intervention training.

Behavioral: Psychoeducational Training Program

Participants will take part in ten 2-hour sessions over 5 weeks.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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