Cognitive Recovery After Post Stroke Delirium (RECOVER)

University Hospital Tuebingen40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Post Stroke Delirium Cognitive Functioning After Stroke

Interventions

Mulit-componant neuropsychological assessmentDIAGNOSTIC_TEST

Multi-component cognitive assessment including following domains: attention \& information speed, executive functioning, verbal memory, language, visuospatial-construction and orientation.

Multimodal MRIDIAGNOSTIC_TEST

Structural MRI (e.g., MPRAGE, DTI) and functional MRI (introducing a modified working memory task for stroke patients)

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurology, University Hospital Tuebingen

Tübingen, Germany

RECRUITING

Outcomes

Primary Outcomes

Global post-stroke cognitive functioning

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.

Time frame: 90 days

Secondary Outcomes

Domain specific post-stroke cognitive functioning

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.

Time frame: 90 days

Prediction of global post-stroke cognitive outcome

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.

Time frame: 5 - 90 days

Data from ClinicalTrials.gov

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