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

November 6, 2024 updated by: University Hospital Tuebingen

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

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

  • 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

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

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

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
Time Frame: 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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Domain specific post-stroke cognitive functioning
Time Frame: 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.
90 days
Prediction of global post-stroke cognitive outcome
Time Frame: 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.
5 - 90 days

Collaborators and Investigators

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

Sponsor

University Hospital Tuebingen

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)

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

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

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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