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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Baycrest
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Brian Levine, Baycrest
ClinicalTrials.gov Identifier:
NCT01951612
First received: September 24, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted

September 24, 2013
September 24, 2013
November 2011
December 2014   (final data collection date for primary outcome measure)
  • Change from baseline in neuropsychological test performance at post-intervention [ Time Frame: Baseline and post-intervention at 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and follow-up at 2 months ] [ Designated as safety issue: No ]
    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.
Same as current
No Changes Posted
  • Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention [ Time Frame: Baseline and post-intervention at 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and follow-up at 2 months ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors
Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Ischemic White Matter Disease
  • Transient Ischemic Attack
  • Mild Stroke
  • Stroke Risk
  • Behavioral: Executive Function Training Program
    Participants will take part in ten 2-hour sessions over 5 weeks.
  • Behavioral: Psychoeducational Training Program
    Participants will take part in ten 2-hour sessions over 5 weeks.
  • Experimental: Executive Function Training Program
    Participants in this group will receive the novel intervention training.
    Intervention: Behavioral: Executive Function Training Program
  • Active Comparator: Psychoeducational Training Program
    Participants in this group will receive the control intervention training.
    Intervention: Behavioral: Psychoeducational Training Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Brian Levine, PhD 416-785-2500 ext 3593 blevine@research.baycrest.org
Contact: Aggie Bacopulos, BSc 416-785-2500 ext 3100 abacopulos@research.baycrest.org
Canada
 
NCT01951612
08-53, 232-2009
Not Provided
Brian Levine, Baycrest
Baycrest
Sunnybrook Health Sciences Centre
Principal Investigator: Brian Levine, PhD Rotman Research Institute, Baycrest
Principal Investigator: Gary Turner, PhD Sunnybrook Health Sciences Centre
Principal Investigator: Sandra Black, MD Sunnybrook Health Sciences Centre
Baycrest
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP