Recruiting

Cognitive Rehabilitation

Sponsor:

Baycrest

Code:

NCT01951612

Conditions

Ischemic White Matter Disease

Transient Ischemic Attack

Mild Stroke

Stroke Risk

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Executive Function Training Program

Psychoeducational Training Program

Study Details

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.

Conditions

Ischemic White Matter Disease

Transient Ischemic Attack

Mild Stroke

Stroke Risk

Study ID

NCT01951612

Start date

Nov, 2011

Status verified date

Jul, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Executive Function Training Program

Participants in this group will receive the novel intervention training.

active comparator: Psychoeducational Training Program

Participants in this group will receive the control intervention training.

Interventions

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.

Primary outcome measure

  • Change from baseline in neuropsychological test performance at post-intervention [ Time Frame: Baseline and post-intervention at 10 weeks ]
  • Change from baseline in neuropsychological test performance at 2 month follow-up [ Time Frame: Baseline and follow-up at 2 months ]

Central Contacts and Locations

Locations

Baycrest

Recruiting

Toronto, Ontario, Canada, M6A 2E1

Contacts

Principal Investigator:

Brian Levine, PhD

More Information

Sponsor

Baycrest

Last update posted

Jul 20, 2016

Last verified

Jul, 2016

Keywords

  • cognitive impairment
  • ischemic white matter disease
  • small vessel disease
  • transient ischemic attack
  • mild stroke
  • stroke risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baycrest on 2016-07-20.