Clinical trial NCT02585349: Cognition and Affect After Stroke: a Prospective Evaluation of Risks
Official title: Cognition and Affect After Stroke: a Prospective Evaluation of Risks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Cognitive Impairment
Post-stroke Depression
Post-stroke Apathy
Post-stroke Dementia
Vascular Dementia
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: first-ever and recurrent ischemic and hemorrhagic stroke patients

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.


Eligibility criteria: 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)

Primary outcomes:
measure: vascular cognitive impairment
timeFrame: 12 months
measure: post-stroke depression
timeFrame: 12 months
measure: post-stroke apathy
timeFrame: 12 months
Secondary outcomes:
measure: change in cognitive function
timeFrame: 12 months
measure: incident post-stroke dementia
timeFrame: 12 months
measure: change in quality of life
timeFrame: 12 months
measure: change in functional ability
timeFrame: 12 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MaastrichtUMC
Study officials:
affiliation: Maastricht University Medical Center
name: Sebastian Köhler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Douven E, Schievink SH, Verhey FR, van Oostenbrugge RJ, Aalten P, Staals J, Kohler S. The Cognition and Affect after Stroke - a Prospective Evaluation of Risks (CASPER) study: rationale and design. BMC Neurol. 2016 May 12;16:65. doi: 10.1186/s12883-016-0588-1.
citation: Douven E, Kohler S, Rodriguez MMF, Staals J, Verhey FRJ, Aalten P. Imaging Markers of Post-Stroke Depression and Apathy: a Systematic Review and Meta-Analysis. Neuropsychol Rev. 2017 Sep;27(3):202-219. doi: 10.1007/s11065-017-9356-2. Epub 2017 Aug 22.
citation: Douven E, Kohler S, Schievink SHJ, van Oostenbrugge RJ, Staals J, Verhey FRJ, Aalten P. Temporal Associations between Fatigue, Depression, and Apathy after Stroke: Results of the Cognition and Affect after Stroke, a Prospective Evaluation of Risks Study. Cerebrovasc Dis. 2017;44(5-6):330-337. doi: 10.1159/000481577. Epub 2017 Oct 26.
citation: Douven E, Kohler S, Schievink SHJ, van Oostenbrugge RJ, Staals J, Verhey FRJ, Aalten P. Baseline Vascular Cognitive Impairment Predicts the Course of Apathetic Symptoms After Stroke: The CASPER Study. Am J Geriatr Psychiatry. 2018 Mar;26(3):291-300. doi: 10.1016/j.jagp.2017.09.022. Epub 2017 Sep 28.
citation: Douven E, Aalten P, Staals J, Schievink SHJ, van Oostenbrugge RJ, Verhey FRJ, Kohler S. Co-occurrence of depressive symptoms and executive dysfunction after stroke: associations with brain pathology and prognosis. J Neurol Neurosurg Psychiatry. 2018 Aug;89(8):859-865. doi: 10.1136/jnnp-2017-317548. Epub 2018 Feb 8.