Cognitive Recovery After Post Stroke Delirium [RECOVER] a Longitudinal Pilot Proof of Concept Study in Stroke Patients With/without Delirium
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post Stroke Delirium
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Global post-stroke cognitive functioning
- Status
- Recruiting
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 60 years
- •Ischemic stroke: Stroke Onset ≤ 96h, hospital admission ≤ 48h
- •NIHSS ≥ 1
- •Informed consent by patient or legal guardian
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
- Domain specific post-stroke cognitive functioning(90 days)
- Prediction of global post-stroke cognitive outcome(5 - 90 days)