Cognition and Affect After Stroke: a Prospective Evaluation of Risks (CASPER)

August 23, 2022 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

first-ever and recurrent ischemic and hemorrhagic stroke patients

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vascular cognitive impairment
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
slope analyses of neuropsychological trajectories in various cognitive domains
12 months
incident post-stroke dementia
Time Frame: 12 months
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
Time Frame: 12 months
measured with the stroke-specific quality of life scale to evaluate health-related quality of life
12 months
change in functional ability
Time Frame: 12 months
measured with the Barthel Index and Lawton questionnaires
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Sebastian Köhler, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 23, 2015

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 12-3-068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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