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

Transient Ischemic Attack Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01951612
• Other study ID #: 08-53
• Secondary ID: 232-2009
• Status: Recruiting
• Phase: N/A
• First received: September 24, 2013
• Last updated: July 18, 2016
• Start date: November 2011
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Baycrest
• Contact: Brian Levine, PhD
• Phone: 416-785-2500
• Email: blevine[@]research.baycrest.org
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Ischemic White Matter Disease
• Leukoencephalopathies
• Mild Stroke
• Stroke
• Stroke Risk
• Transient Ischemic Attack

Intervention

Behavioral:
• Executive Function Training Program
Participants will take part in ten 2-hour sessions over 5 weeks.
• Psychoeducational Training Program
Participants will take part in ten 2-hour sessions over 5 weeks.

Locations

Country	Name	City	State
Canada	Baycrest	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Baycrest	Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and post-intervention at 10 weeks	No
Primary	Change from baseline in neuropsychological test performance at 2 month follow-up	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.	Baseline and follow-up at 2 months	No
Secondary	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.	Baseline and post-intervention at 10 weeks	No
Secondary	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.	Baseline and follow-up at 2 months	No