Department of Neurology, University Hospital Tuebingen
Tübingen, Germany
Location status: Recruiting
Recruiting
NCT Number: NCT06680336
Cognitive Recovery After Post Stroke Delirium (RECOVER)
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).
Recruiting
Interested in participating?
Request InfoKey information
Age range
60 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Mulit-componant neuropsychological assessment
Diagnostic TestMulti-component cognitive assessment including following domains: attention & information speed, executive functioning, verbal memory, language, visuospatial-construction and orientation.
Multimodal MRI
Diagnostic TestStructural MRI (e.g., MPRAGE, DTI) and functional MRI (introducing a modified working memory task for stroke patients)
Primary outcomes
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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.
Secondary outcomes
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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.
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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.
Sponsors and collaborators
Lead sponsor
University Hospital Tuebingen
Other
Registry information
Official study title
Cognitive Recovery After Post Stroke Delirium [RECOVER] a Longitudinal Pilot Proof of Concept Study in Stroke Patients With/without Delirium
Acronym: RECOVER
Important dates
- Study start
- 2023
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Nov 8, 2024
- Registry last updated
- Nov 8, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.