Ischemic White Matter DiseaseNCT01951612
Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors
A study testing Executive Function Training Program and Psychoeducational Training Program in people with Ischemic White Matter Disease and Transient Ischemic Attack, run by Baycrest at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic White Matter Disease, Transient Ischemic Attack, Mild Stroke
- What is being tested?
- Executive Function Training Program and Psychoeducational Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Baycrest
Toronto, Ontario, M6A 2E1
Brian Levine, PhD, 416-785-2500 ext. 3593, blevine@research.baycrest.org
Nivethika Jeyakumar, BSc, 416-785-2500 ext. 3104, njeyakumar@research.baycrest.org
About this study
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.
- Being tested
- Executive Function Training Program, Psychoeducational Training Program
- Keywords
- cognitive impairment, ischemic white matter disease, small vessel disease, transient ischemic attack, mild stroke, stroke risk
- Medical subject headings
- Ischemic Attack, Transient, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive Function Training ProgramBehavioural
Participants will take part in ten 2-hour sessions over 5 weeks.
Psychoeducational Training ProgramBehavioural
Participants will take part in ten 2-hour sessions over 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Executive Function Training Program | Experimental | Participants in this group will receive the novel intervention training. Receives: Behavioral: Executive Function Training Program |
| Psychoeducational Training Program | Active comparator | Participants in this group will receive the control intervention training. Receives: Behavioral: Psychoeducational Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and follow-up at 2 months
Secondary outcomes (2)
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.
Measured: Baseline and post-intervention at 10 weeks
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.
Measured: Baseline and follow-up at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic White Matter DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Brian Levine, Baycrest
- Investigators
- Brian Levine, PhD, Principal investigator, Rotman Research Institute, BaycrestGary Turner, PhD, Principal investigator, Sunnybrook Health Sciences CentreSandra Black, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951612
- Sponsor's protocol ID
- 08-53
- Other IDs
- 232-2009
- Status last verified
- Jul 2016
- First submitted
- 24 Sep 2013
- Last updated
- 20 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors
- ClinicalTrials.gov ID
- NCT01951612
- Acronym / sponsor ID
- 08-53
- Keywords
- cognitive impairment, ischemic white matter disease, small vessel disease, transient ischemic attack, mild stroke, stroke risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- Nov 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Executive Function Training Program | Experimental | Behavioral: Executive Function Training ProgramParticipants in this group will receive the novel intervention training. |
| Psychoeducational Training Program | Active comparator | Behavioral: Psychoeducational Training ProgramParticipants in this group will receive the control intervention training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Executive Function Training ProgramParticipants will take part in ten 2-hour sessions over 5 weeks. | Behavioural | Executive Function Training Program |
| Psychoeducational Training ProgramParticipants will take part in ten 2-hour sessions over 5 weeks. | Behavioural | Psychoeducational Training Program |
Primary outcome
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.
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.
2 secondary outcomes
Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Levine, PhD principal investigator
Rotman Research Institute, Baycrest
Gary Turner, PhD principal investigator
Sunnybrook Health Sciences Centre
Sandra Black, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Executive Function Training Program and Psychoeducational Training Program in people with Ischemic White Matter Disease and Transient Ischemic Attack, run by Baycrest at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Levine, PhD (416-785-2500 ext. 3593, blevine@research.baycrest.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in neuropsychological test performance at post-intervention (time frame: Baseline and post-intervention at 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.