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

NCT01951612 | Unknown

• 2 other identifiers: 08-53232-2009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention

  Baseline and post-intervention at 10 weeks

• Change from baseline in neuroimaging (fMRI/EEG) markers at 2 month follow-up

  Baseline and follow-up at 2 months

Study Arms (2)

Executive Function Training Program

EXPERIMENTAL

Participants in this group will receive the novel intervention training.

Behavioral: Executive Function Training Program

Psychoeducational Training Program

ACTIVE COMPARATOR

Participants in this group will receive the control intervention training.

Behavioral: Psychoeducational Training Program

Interventions

Executive Function Training Program BEHAVIORAL

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

Executive Function Training Program

Psychoeducational Training Program BEHAVIORAL

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

Psychoeducational Training Program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baycrest: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

Baycrest

Toronto, Ontario, M6A 2E1, Canada

RECRUITING

MeSH Terms

Conditions

Ischemic Attack, Transient; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Levine, PhD

CONTACT

416-785-2500; blevine@research.baycrest.org

Nivethika Jeyakumar, BSc

CONTACT

416-785-2500; njeyakumar@research.baycrest.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 26, 2013
• Study Start: November 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

CA (1)