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

July 18, 2016 updated by: Brian Levine, Baycrest

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Executive Function Training Program
Participants in this group will receive the novel intervention training.
Behavioral: Executive Function Training Program
Participants will take part in ten 2-hour sessions over 5 weeks.
ACTIVE_COMPARATOR: Psychoeducational Training Program
Participants in this group will receive the control intervention training.
Behavioral: Psychoeducational Training Program
Participants will take part in ten 2-hour sessions over 5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in neuropsychological test performance at post-intervention
Time Frame: Baseline and post-intervention at 10 weeks
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
Time Frame: Baseline and follow-up at 2 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention
Time Frame: Baseline and post-intervention at 10 weeks
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
Change from baseline in neuroimaging (fMRI/EEG) markers at 2 month follow-up
Time Frame: Baseline and follow-up at 2 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baycrest

Collaborators

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Brian Levine, PhD, Rotman Research Institute, Baycrest
  • Principal Investigator: Gary Turner, PhD, Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (ESTIMATE)

September 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-53
  • 232-2009 (OTHER: Sunnybrook Health Sciences Centre)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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