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

NCT ID: NCT01951612

Last Updated: 2016-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic White Matter Disease Transient Ischemic Attack Mild Stroke Stroke Risk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Executive Function Training Program

Participants in this group will receive the novel intervention training.

Group Type EXPERIMENTAL

Executive Function Training Program

Intervention Type BEHAVIORAL

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

Psychoeducational Training Program

Participants in this group will receive the control intervention training.

Group Type ACTIVE_COMPARATOR

Psychoeducational Training Program

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Executive Function Training Program

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

Intervention Type BEHAVIORAL

Psychoeducational Training Program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

Baycrest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brian Levine

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brian Levine, PhD

Role: PRINCIPAL_INVESTIGATOR

Rotman Research Institute, Baycrest

Gary Turner, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Sandra Black, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baycrest

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Brian Levine, PhD

Role: CONTACT

416-785-2500 ext. 3593

Nivethika Jeyakumar, BSc

Role: CONTACT

416-785-2500 ext. 3104

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Brian Levine, PhD

Role: primary

416-785-2500 ext. 3593

Nivethika Jeyakumar, BSc

Role: backup

416-785-2500 ext. 3104

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

232-2009

Identifier Type: OTHER

Identifier Source: secondary_id

08-53

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Early-phase Telecare Programs for Minor Stroke
NCT06306144 NOT_YET_RECRUITING NA
Cognitive Rehabilitation for PD
NCT03335150 COMPLETED NA