Cognition and Affect After Stroke: a Prospective Evaluation of Risks

NCT02585349 | Completed

• 1 other identifier: METC 12-3-068
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• change in cognitive function

  12 months

• incident post-stroke dementia

  12 months

• change in quality of life

  12 months

• change in functional ability

  12 months

Study Arms (1)

First-ever and recurrent ischemic and hemorrhagic stroke

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

first-ever and recurrent ischemic and hemorrhagic stroke patients

You may qualify if:

• 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

You may not qualify if:

• 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
• Severe aphasia (as it interferes with understanding and following test instructions)

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MaastrichtUMC

Maastricht, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 27176617 RESULT

• 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.

  PMID: 28831649 RESULT

• 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.

  PMID: 29073590 RESULT

• 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.

  PMID: 29079017 RESULT

• 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.

  PMID: 29439160 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Buffycoats from EDTA tubes are taken for DNA extraction (ApoE, CLU, PICALM, CR1, ACE, MTHFR). One PAXgene tube is collected to ensure long-term stability of RNA. Extraction of RNA and subsequent analysis of expression of inflammatory and stroke-related genes at the mRNA level will be done.

MeSH Terms

Conditions

Dementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sebastian Köhler, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: October 23, 2015
• Study Start: April 1, 2013
• Primary Completion: October 31, 2016
• Study Completion: December 31, 2018
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

NL (1)