Cognitive Functioning After Stroke, Post Stroke Delirium
Conditions
Brief summary
RECOVER is a Proof-of-Concept study on cognitive functioning following a longitudinal design with three measurements (during the acute- and post-acute phases of a stroke and a 3-month follow-up) and two equally-sized stroke patient groups: a post-stroke delirium(PSD), and a non-PSD group (control group). Cognitive functioning will be assessed using a multi-component neuropsychological assessment and tasked-based functional MRI (introducing a modified working memory task).
Interventions
DIAGNOSTIC_TESTMulit-componant neuropsychological assessment
Multi-component cognitive assessment including following domains: attention & information speed, executive functioning, verbal memory, language, visuospatial-construction and orientation.
DIAGNOSTIC_TESTMultimodal MRI
Structural MRI (e.g., MPRAGE, DTI) and functional MRI (introducing a modified working memory task for stroke patients)
Sponsors
University Hospital Tuebingen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Longitudinal study with 3 measurements (S1, S2, S3) and two groups of stroke patients (post-stroke-delirium (PSD) patients, non PSD patients)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 60 years * Ischemic stroke: Stroke Onset ≤ 96h, hospital admission ≤ 48h * NIHSS ≥ 1 * Informed consent by patient or legal guardian
Exclusion criteria
* Aphasia * Pre-existing conditions such as Dementia, psychiatric disorders (e.g., Depression, Schizophrenia) * MRI contraindication such as certain metal implants * Reduced consciousness, defined as Glasgow Coma Scale (GCS) ≤ 8 * Delirium onset before study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global post-stroke cognitive functioning | 90 days | The primary endpoint will be a between-group comparison of the cognitive outcome, defined as global post-stroke cognitive functioning, at 3 months follow-up (S3), using multimodal data generated from the neuropsychological assessment and tasked-based fMRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Domain specific post-stroke cognitive functioning | 90 days | The second endpoint will be a between-group comparison of the cognitive outcome, defined as domain specific post-stroke cognitive functioning, at 3 months follow-up, using multimodal data generated from the neuropsychological assessment and tasked-based fMRI. |
| Prediction of global post-stroke cognitive outcome | 5 - 90 days | A multivariate linear regression model will be used to establish a multi-item prognostic or predictive tool for cognitive outcome, defined as global post-stroke cognitive functioning at the follow-up measurement (S3) by parameters assessed at S1. |
Countries
Germany
Outcome results
None listed