Post Stroke DeliriumRECOVERNCT06680336
Cognitive Recovery After Post Stroke Delirium (RECOVER)
A study testing Mulit-componant neuropsychological assessment and Multimodal MRI in people with Post Stroke Delirium and Cognitive Functioning After Stroke, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Post Stroke Delirium, Cognitive Functioning After Stroke
- What is being tested?
- Mulit-componant neuropsychological assessment and Multimodal MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2023to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
- Ischemic stroke: Stroke Onset ≤ 96h, hospital admission ≤ 48h
- NIHSS ≥ 1
- Informed consent by patient or legal guardian
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, University Hospital Tuebingen
Tübingen
Lena Geiger-Primo, MD, +497071 29 80684, lena.geiger-primo@med.uni-tuebingen.de
About this study
Official title: 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).
- Being tested
- Mulit-componant neuropsychological assessment, Multimodal MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulit-componant neuropsychological assessmentDiagnostic test
Multi-component cognitive assessment including following domains: attention \& information speed, executive functioning, verbal memory, language, visuospatial-construction and orientation.
Multimodal MRIDiagnostic test
Structural MRI (e.g., MPRAGE, DTI) and functional MRI (introducing a modified working memory task for stroke patients)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Mulit-componant neuropsychological assessment; Diagnostic Test: Multimodal MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (2)
Domain specific post-stroke cognitive functioning
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.
Measured: 90 days
Prediction of global post-stroke cognitive outcome
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.
Measured: 5 - 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Dec 2023
- Primary completionAug 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Stroke DeliriumStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal study with 3 measurements (S1, S2, S3) and two groups of stroke patients (post-stroke-delirium (PSD) patients, non PSD patients)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680336
- Sponsor's protocol ID
- AKF_1004-0-0
- Acronym
- RECOVER
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geiger LS, Klutz S, Mychajliw C, Gabele C, Jooss A, Single C, Feil K, Ziemann U, Mengel A. Cognitive Recovery After Poststroke Delirium (RECOVER): Protocol for a Longitudinal Multimodal Study on Cognitive Assessment in Patients With Stroke. JMIR Res Protoc. 2026 Jan 12;15:e77508. doi: 10.2196/77508.
PubMed 41539969
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Recovery After Post Stroke Delirium [RECOVER] a Longitudinal Pilot Proof of Concept Study in Stroke Patients With/without Delirium
- ClinicalTrials.gov ID
- NCT06680336
- Acronym / sponsor ID
- RECOVER / AKF_1004-0-0
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal study with 3 measurements (S1, S2, S3) and two groups of stroke patients (post-stroke-delirium (PSD) patients, non PSD patients)
| Arm | Type | Receives |
|---|---|---|
| Post-stroke Delirium | Other | Diagnostic Test: Mulit-componant neuropsychological assessment, Diagnostic Test: Multimodal MRIAssessment 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. |
| Non-post-stroke Delirium | Other | Diagnostic Test: Mulit-componant neuropsychological assessment, Diagnostic Test: Multimodal MRIAssessment 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 60 years
- Ischemic stroke: Stroke Onset ≤ 96h, hospital admission ≤ 48h
- NIHSS ≥ 1
- Informed consent by patient or legal guardian
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulit-componant neuropsychological assessmentMulti-component cognitive assessment including following domains: attention \& information speed, executive functioning, verbal memory, language, visuospatial-construction and orientation. | Diagnostic test | Non-post-stroke Delirium, Post-stroke Delirium |
| Multimodal MRIStructural MRI (e.g., MPRAGE, DTI) and functional MRI (introducing a modified working memory task for stroke patients) | Diagnostic test | Non-post-stroke Delirium, Post-stroke Delirium |
Primary outcome
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.
2 secondary outcomes
Domain specific post-stroke cognitive functioning
Time frame: 90 days
Prediction of global post-stroke cognitive outcome
Time frame: 5 - 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Derived from this study: PubMed 41539969Geiger LS, Klutz S, Mychajliw C, Gabele C, Jooss A, Single C, Feil K, Ziemann U, Mengel A. Cognitive Recovery After Poststroke Delirium (RECOVER): Protocol for a Longitudinal Multimodal Study on Cognitive Assessment in Patients With Stroke. JMIR Res Protoc. 2026 Jan 12;15:e77508. doi: 10.2196/77508.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Neurology, University Hospital Tuebingen
Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulit-componant neuropsychological assessment and Multimodal MRI in people with Post Stroke Delirium and Cognitive Functioning After Stroke, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global post-stroke cognitive functioning (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06680336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.