Clinical trial NCT01951612: Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors
Official title: Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic White Matter Disease
Transient Ischemic Attack
Mild Stroke
Stroke Risk
Keywords: cognitive impairment
ischemic white matter disease
small vessel disease
transient ischemic attack
mild stroke
stroke risk
Lead sponsor: Baycrest
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2013-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in neuropsychological test performance at post-intervention
timeFrame: Baseline and post-intervention at 10 weeks
measure: Change from baseline in neuropsychological test performance at 2 month follow-up
timeFrame: Baseline and follow-up at 2 months
Secondary outcomes:
measure: Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention
timeFrame: Baseline and post-intervention at 10 weeks
measure: Change from baseline in neuroimaging (fMRI/EEG) markers at 2 month follow-up
timeFrame: Baseline and follow-up at 2 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest
state: Ontario
Study officials:
affiliation: Rotman Research Institute, Baycrest
name: Brian Levine, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Gary Turner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Sandra Black, MD
role: PRINCIPAL_INVESTIGATOR
References: