Cognitive Recovery After Post Stroke Delirium (RECOVER)

NCT ID: NCT06680336

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Post Stroke Delirium Cognitive Functioning After Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Longitudinal study with 3 measurements (S1, S2, S3) and two groups of stroke patients (post-stroke-delirium (PSD) patients, non PSD patients)
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Mulit-componant neuropsychological assessment

Intervention Type DIAGNOSTIC_TEST

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

Multimodal MRI

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type OTHER

Mulit-componant neuropsychological assessment

Intervention Type DIAGNOSTIC_TEST

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

Multimodal MRI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Mulit-componant neuropsychological assessment

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

Intervention Type DIAGNOSTIC_TEST

Multimodal MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Neurology, University Hospital Tuebingen

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Lena Geiger-Primo, MD

Role: primary

+497071 29 80684

Other Identifiers

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AKF_1004-0-0

Identifier Type: -

Identifier Source: org_study_id

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