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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01951612
Other study ID # 08-53
Secondary ID 232-2009
Status Recruiting
Phase N/A
First received September 24, 2013
Last updated July 18, 2016
Start date November 2011
Est. completion date December 2016

Study information

Verified date July 2016
Source Baycrest
Contact Brian Levine, PhD
Phone 416-785-2500
Email blevine@research.baycrest.org
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
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.

Locations

Country Name City State
Canada Baycrest Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Baycrest Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Secondary Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention 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 No
Secondary Change from baseline in neuroimaging (fMRI/EEG) markers at 2 month follow-up 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 No
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