Cognition and affect after stroke: a prospective evaluation of risks
- Conditions
- cerebrovascular accidentstroke1000796310027946
- Registration Number
- NL-OMON45133
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
- First-ever ischemic stroke.
- MMSE score *15 (to ensure valid testing).
- Written informed consent.
- Sufficient knowledge of the Dutch language.
- Participation of informant.
- Recurrent stroke.
- Age younger than 40 years (to exclude atypical strokes).
- Pre-stroke dementia (assessed by a semi-structured interview with a relative, based on DSM-IV criteria of dementia).
- Psychiatric and neurological disease other than the qualifying event known to affect cognition such as schizophrenia, bipolar disorder, substance abuse, Parkinson*s disease, or epilepsy.
- Current episode of depression at admission (as evidenced by medical records and patient or informant interview). In contrast, a lifetime history of depression will not be considered as a reason for exclusion as this is considered a potential risk factor for PSD.
- Severe aphasia (as it interferes with understanding and following test instructions).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are a) vascular cognitive impairment (this term<br /><br>includes both vascular MCI and post-stroke dementia and is therefore broadly<br /><br>defined as a score * 1.5 standard deviations below the general population mean<br /><br>(based on available norm scores); also, it must represent a significant decline<br /><br>from premorbid levels of functioning (based on informant interview and<br /><br>patient's self-report), and considered a consequence of vascular<br /><br>insufficiency/disease), b) minor or major depression as defined by a diagnostic<br /><br>interview and severity ratings, and c) apathy defined by symptoms frequency<br /><br>severity ratings.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include a) slope analyses of neuropsychological<br /><br>trajectories in the domains of memory, executive functions, attention and<br /><br>information processing speed during the observational period, b) incident<br /><br>post-stroke dementia, c) mortality, d) recurrent stroke events, e) quality of<br /><br>life and f) level of disability.<br /><br><br /><br>Other study parameters are: comprehensive baseline assessments, which include<br /><br>history of depression, medical history, 3T structural brain MRI, blood samples<br /><br>to determine levels of inflammatory and immunological markers (acute response<br /><br>proteins, cytokines, cell adhesion molecules, antibodies), and DNA (for genetic<br /><br>testing of candidate genotypes). </p><br>