Cognitive Recovery After Post Stroke Delirium (RECOVER)

NCT06680336 | Recruiting

• 1 other identifier: AKF_1004-0-0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Post Stroke Delirium; Cognitive Functioning After Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Domain specific post-stroke cognitive functioning

  90 days

• Prediction of global post-stroke cognitive outcome

  5 - 90 days

Study Arms (2)

Post-stroke Delirium

OTHER

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; Diagnostic Test: Multimodal MRI

Non-post-stroke Delirium

OTHER

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; Diagnostic Test: Multimodal MRI

Interventions

Mulit-componant neuropsychological assessment DIAGNOSTIC_TEST

Multi-component cognitive assessment including following domains: attention \& information speed, executive functioning, verbal memory, language, visuospatial-construction and orientation.

Non-post-stroke Delirium; Post-stroke Delirium

Multimodal MRI DIAGNOSTIC_TEST

Structural MRI (e.g., MPRAGE, DTI) and functional MRI (introducing a modified working memory task for stroke patients)

Non-post-stroke Delirium; Post-stroke Delirium

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years
• Ischemic stroke: Stroke Onset ≤ 96h, hospital admission ≤ 48h
• NIHSS ≥ 1
• Informed consent by patient or legal guardian

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Department of Neurology, University Hospital Tuebingen

Tübingen, Germany

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal study with 3 measurements (S1, S2, S3) and two groups of stroke patients (post-stroke-delirium (PSD) patients, non PSD patients)

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: November 8, 2024
• Study Start: December 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)