Cognitive Recovery After Post Stroke Delirium (RECOVER)

Not Applicable

Recruiting

• Conditions: Post Stroke Delirium; Cognitive Functioning After Stroke

• Registration Number: NCT06680336
• Lead Sponsor: University Hospital Tuebingen

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Study First Posted: 2024-11-08
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-08
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Neurology, University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany