Cognition and Affect After Stroke: a Prospective Evaluation of Risks

Study Overview
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Brief Summary
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Stroke is a leading cause of disability, affecting about 34,000 to 41,000 individuals in the Netherlands of middle and old age every year. Due to the aging of the population, this figure will increase considerably over the next decades (Struijs et al., 2005). Twenty-five percent of stroke patients die within one month, making stroke a major risk factor for premature death in developed countries. According to the World Health Organization, stroke is the third leading cause of the burden of disease in middle and high-income countries (World Health Organization, 2008). It has a significant negative impact on quality of life of both the patients as well as their caregivers and significant others. Surviving stroke patients often struggle with its manifold and lifelong lasting consequences, with 35 percent of patients being functionally dependent one year after stroke (Wolfe, 2000) and cognitive and emotional changes which are found up to two years post-stroke (Rasquin, Lodder, & Verhey, 2005). Depression, apathy, and cognitive impairment are very prevalent and significantly contribute to the burden of the disease, but their etiologies remain poorly understood. The aim of the CASPER study is to gain more insight into the etiologies of post-stroke depression (PSD), post-stroke apathy (PSA), vascular cognitive impairment (VCI), and post-stroke dementia. Therefore, the primary objectives are to identify biomarker-based predictors of PSD, PSA, and VCI. A secondary aim is to study effect modulation, especially the interaction between cerebrovascular disease, neurodegenerative changes and inflammation in post-stroke dementia. CASPER is a prospective clinical cohort study of 250 first-ever ischemic stroke patients with serial assessments at baseline (10 to 12 weeks after stroke), six and 12 months after baseline. Another wave (36 month after baseline) was later added.

Official Title
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Cognition and Affect After Stroke: a Prospective Evaluation of Risks

Conditions
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Vascular Cognitive Impairment, Post-stroke Depression, Post-stroke Apathy, Post-stroke Dementia, Vascular Dementia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First-ever or recurrent ischemic or hemorrhagic stroke MMSE score ≥15 (to ensure valid testing) Written informed consent Sufficient knowledge of the Dutch language Preferably participation of an informant Exclusion Criteria: Age younger than 40 years (to exclude atypical strokes) Pre-stroke dementia (assessed by a semi-structured interview with a relative, based on clinical diagnosis or IQ-CODE) in the five years prior to stroke 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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First-ever and recurrent ischemic and hemorrhagic stroke<br>First-ever and recurrent ischemic and hemorrhagic stroke patients are enrolled in the study. Recurrent strokes are only included if the patient is fully recovered from the previous event, which occurred at least 3 years ago, without obvious residual symptoms. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular cognitive impairment | defined as a score smaller or equal to 1.5 standard deviations below the general population mean in two or more cognitive domains, based on available norm scores for age, gender and level of education for the Dutch general population | 12 months | 
| post-stroke depression | measured by the Mini International Neuropsychiatric Interview and the Montgomery-Asberg Depression Rating Scale to assess severity. In addition, the Hospital Anxiety and Depression Scale is used to identify levels of anxiety and depression. | 12 months | 
| post-stroke apathy | assessed by the Apathy Evaluation Scale (informant- and clinician rated version is used) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in cognitive function | slope analyses of neuropsychological trajectories in various cognitive domains | 12 months | 
| incident post-stroke dementia | diagnosed according to the criteria proposed by the National instate of Neurological Disorders and Strokes - Association Internationale pour la Recherch et l'Enseignement en Neurosciences | 12 months | 
| change in quality of life | measured with the stroke-specific quality of life scale to evaluate health-related quality of life | 12 months | 
| change in functional ability | measured with the Barthel Index and Lawton questionnaires | 12 months |