An interventional study of Executive Function Training Program and Psychoeducational Training Program in Ischemic White Matter Disease, Transient Ischemic Attack and Mild Stroke, sponsored by Baycrest. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-07-20.
Sponsored by Baycrest · Not applicable, Interventional, and Treatment
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.
329 studies on the registry are indexed under Ischemic Attack, Transient; 71 are open to participants now.
This study's planned enrollment of 40 is below the median of 217 across 178 interventional studies indexed under Ischemic Attack, Transient.
Browse Ischemic Attack, Transient studies →Baycrest is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive the novel intervention training.
Behavioral: Executive Function 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.
Participants will take part in ten 2-hour sessions over 5 weeks.
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.
Time frame: 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.
Time frame: Baseline and follow-up at 2 months
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.
Time frame: 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.
Time frame: Baseline and follow-up at 2 months
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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