PRediction Of Cognitive Recovery After Stroke: a role for new MRI modalities in daily clinical practice?

Completed

Conditions: cerebrovascular accident
Stroke
10007963

Registration Number: NL-OMON46000

Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 350

Inclusion Criteria

For cognitive impaired group:
Ischemic stroke (clinical diagnosis, CT-scan confirmed or not)
Age 50 years or older
Montreal Cognitive Assessment (MoCa) score <26 ;For control group
Ischemic stroke (clinical diagnosis, CT-scan confirmed or not)
Age 50 years or older
Montreal Cognitive Assessment (MoCa) score equal to or above 26

Exclusion Criteria

-Pre-existent dementia (clinical diagnosis) and/or Pre-existing cognitive impairment (score of 3.6 or higher on the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE))
-Life expectancy < 1 year
-Very severe stroke needing long term nursing care facilities
-History of major neurological disease interfering with cognitive functioning
-Pre-stroke dependence in activities of daily living (Barthel Index below 18);
-Insufficient command of the Dutch language in order to participate and understand questionnaires
- Impossibilitiy to participate in a neuropsychological assessment
- Not able to undergo an MRI-scan due to contra-indications

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure of this study is recovery of cognitive function in<br /><br>the first year after stroke, measured with a 60 minute neuropsychological<br /><br>assessment battery<br /><br>For the primary analyses cognitive recovery is operationalized as a transition<br /><br>from a mild vascular cognitive disorder in the acute stage to no<br /><br>disorder after one year or a transition from a major vascular disorder in the<br /><br>acute stage to a mild or no vascular cognitive disorder after one year.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary cognitive outcome measure is deterioration of cognitive function,<br /><br>operationalized as transition from mild to major vascular cognitive disorder,<br /><br>or a transition from no disorder in the acute stage to a mild or major vascular<br /><br>cognitive disorder after one year.<br /><br>Additional outcome measures that will be collected include also important<br /><br>outcome parameters as Cognitive complaints (CLCE-24), self-efficacy (Self<br /><br>Efficacy for symptom management scale (SEsx)), Quality of Life measured by the<br /><br>Stroke-Specific Quality of Life Scale (SS-QOL), emotional functioning (Hospital<br /><br>Anxiety and Depression Scale (HADS), neuropsychiatric inventory-questionnaire<br /><br>(NPI-Q)) and participation measured by Utrecht Scale for Evaluation of<br /><br>Rehabilitation-Participation (User-P) and Patient Reported Outcomes Measurement<br /><br>System (PROMIS-10) will be assessed at one year post stroke.</p><br>