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Cognition and Affect After Stroke: a Prospective Evaluation of Risks

Cognition and Affect After Stroke: a Prospective Evaluation of Risks

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02585349
Acronym
CASPER
Enrollment
250
Registered
2015-10-23
Start date
2013-04-01
Completion date
2018-12-31
Last updated
2022-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

None listed

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
vascular cognitive impairment12 monthsdefined 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
post-stroke depression12 monthsmeasured 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.
post-stroke apathy12 monthsassessed by the Apathy Evaluation Scale (informant- and clinician rated version is used)

Secondary

MeasureTime frameDescription
change in cognitive function12 monthsslope analyses of neuropsychological trajectories in various cognitive domains
change in functional ability12 monthsmeasured with the Barthel Index and Lawton questionnaires
incident post-stroke dementia12 monthsdiagnosed according to the criteria proposed by the National instate of Neurological Disorders and Strokes - Association Internationale pour la Recherch et l'Enseignement en Neurosciences
change in quality of life12 monthsmeasured with the stroke-specific quality of life scale to evaluate health-related quality of life

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026