Cognitive Recovery After Post Stroke Delirium (RECOVER) (RECOVER)

Cognitive Recovery After Post Stroke Delirium [RECOVER] a Longitudinal Pilot Proof of Concept Study in Stroke Patients With/without Delirium

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 Overview

• Status: Recruiting
• Conditions: Post Stroke Delirium; Cognitive Functioning After Stroke
• Intervention / Treatment: Diagnostic test: Mulit-componant neuropsychological assessment; Diagnostic test: Multimodal MRI

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany
    • Recruiting
    • Department of Neurology, University Hospital Tuebingen
    • Contact: Lena Geiger-Primo, MD; Phone Number: +497071 29 80684; Email: lena.geiger-primo@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Post-stroke Delirium; Assessment of cognitive functioning using a multi-component neuropsychological assessment and tasked-based functional MRI (introducing a modified working memory task) at three time points S1, S2, S3.	Diagnostic test: Mulit-componant neuropsychological assessment; Multi-component cognitive assessment including following domains: attention & information speed, executive functioning, verbal memory, language, visuospatial-construction and orientation.; Diagnostic test: Multimodal MRI; Structural MRI (e.g., MPRAGE, DTI) and functional MRI (introducing a modified working memory task for stroke patients)
Other: Non-post-stroke Delirium; Assessment of cognitive functioning using a multi-component neuropsychological assessment and tasked-based functional MRI (introducing a modified working memory task) at three time points S1, S2, S3.	Diagnostic test: Mulit-componant neuropsychological assessment; Multi-component cognitive assessment including following domains: attention & information speed, executive functioning, verbal memory, language, visuospatial-construction and orientation.; Diagnostic test: Multimodal MRI; Structural MRI (e.g., MPRAGE, DTI) and functional MRI (introducing a modified working memory task for stroke patients)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	5 - 90 days

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Stroke; Delirium
• Other Study ID Numbers: AKF_1004-0-0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No