Stroke AcuteCOGISTROKENCT06670716
BRIEF COGNITIVE and DELIRIUM ASSESSMENTS in STROKE PATIENTS
An observational study of Stroke Acute, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
Trial summary
The aim of the project is to validate the ALBA and PICNIR tests for the easy detection of memory and speech disorders in patients after a stroke. Patients, after their first stroke, with the possibility of initial clinical evaluation within 24 hours of admission to the Neurology Clinic ICU, will undergo a neurological… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke Acute
- What is being tested?
- Examination by a speech therapist, Cognitive examination and Examination of delirium
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 3 Apr 2024to 3 May 2026
- How long will I take part?
- 5 Days
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to the monitored bed of the neurological ICU for ischemic or hemorrhagic CVA with the possibility of initial examination within 24 hours of admission (not the onset of CVA), with an anticipated length of hospitalization longer than five days, will be included in the study.
Who may be able to join
- Native speaker of the Czech Republic. Czech must be the patient\'s native language.
- Admission to the monitored bed of the neurological ICU with the possibility of initial examination within 24 hours of admission (not the onset of CVA).
- Anticipated length of hospitalization longer than five days.
- First clinical CVA in life. Subclinical signs of CVA on brain CT are acceptable.
- Absence of previous neurological deficit of any etiology affecting the brain, e.g., trauma, or spinal cord.
- Vigilant, i.e., without quantitative impairment of consciousness. Delirium may be present.
Who cannot join
- Native speaker of the Czech Republic. Czech must be the patient\'s mother tongue.
- Admission to the monitored bed of the neurological ICU with the possibility of initial examination within 24 hours of admission (not the onset of CVA).
- Anticipated length of hospitalization longer than five days.
- First clinical CVA in life. Subclinical signs of CVA on brain CT are acceptable.
- Absence of previous neurological deficit of any etiology affecting the brain, e.g., trauma, or spinal cord.
- Vigilant, i.e., without quantitative impairment of consciousness. Delirium may be present.
Show all 17Show fewer
- Presence of a previous neurological deficit.
- Unfavorable prognosis upon admission.
- Discharge or anticipation of early discharge from the ICU before the follow-up examination after 5 days.
- Transient ischemic attack and conditions mimicking stroke.
- Resolution of deficit before the initial examination.
- Absence of the principal investigator.
- Intubation upon admission.
- Refusal to participate in the study by the patient or relatives.
- Complications during hospitalization affecting brain function, e.g., aspiration with hypoxia.
- Sudden progression of the condition to unconsciousness.
- Unique situations, e.g., acute endarterectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VERY BRIEF SPEECH and MEMORY ASSESSMENTS USING ALBA a PICNIR TESTS and DELIRIUM ASSESSMENTS USING CAM-ICU and ICDSC TESTS in PATIENTS SHORTLY AFTER the STROKE
The aim of the project is to validate the ALBA and PICNIR tests for the easy detection of memory and speech disorders in patients after a stroke. Patients, after their first stroke, with the possibility of initial clinical evaluation within 24 hours of admission to the Neurology Clinic ICU, will undergo a neurological examination, cognitive tests using the ALBA and PICNIR tests, delirium tests using the CAM-ICU and ICDSC tools, and a speech therapy test using the MASTcz tool. If possible, these will be conducted simultaneously in one half-day. A similar structured examination will take place within five days, with a tolerance of one day. Upon demonstrating utility, doctors will be able to utilize the very brief ALBA and POBAV methods for detecting memory and speech disorders in post-stroke patients in clinical practice.
Read the detailed description
Speech and motor production disorders are easily recognizable or examinable symptoms of stroke (Cerebrovascular Accident - CVA). In contrast, memory disorders are rarely examined, primarily within research studies rather than routine clinical practice, for several reasons. Fatigue-related disorders cause difficulties in memory and other cognitive function examinations. Aphasia is accompanied by cognitive deficits, which are not always easy to detect due to speech and motor impairments. Another reason is the scarcity of suitable tests that are brief yet informative. Since stroke patients are typically older, it can be assumed that memory disorders are frequent in this population. There is a bidirectional relationship between cognitive disorders and stroke. Cognitive impairment increases the risk of stroke and death, while post-stroke cognitive impairment may have existed before the stroke or may be partly caused by it. It can occur early or later after the event. Cognitive impairment persists in patients after a CVA, even after successful clinical recovery, and is closely related to poor functional outcomes.
Assessing cognitive impairment after a stroke is significant in both acute and chronic care. It helps to determine whether the patient remembers important information regarding their health status and recommendations for lifestyle changes (e.g., not smoking, adhering to a diabetic diet, regular blood pressure checks), as well as the use of essential treatments like antihypertensives or secondary preventive treatments-antiplatelet and anticoagulant therapy. Speech and memory disorders affect acute and chronic patient care-nursing, caregiving, rehabilitation, and speech therapy, as well as care in the home environment. Expressive aphasia is easily noticed, but often not quantified. Sensory aphasia is generally less recognizable from ordinary contact. The quality of the examination determines the extent of the disorder found. It is crucial for healthcare personnel to understand what to expect regarding collaboration. It is also essential to estimate whether the patient will understand the significance of the communicated information and how well they will cooperate during rehabilitation.
A physician can quickly and easily quantify speech and memory disorders after a stroke using the original Czech and innovative tests, Amnesia Light and Brief Assessment (ALBA) and Picture Naming and Immediate Recall (PICNIR). Although initially developed for patients with cognitive disorders or dementia, they are also well-suited for post-stroke patients. The validated ALBA test involves learning and repeating a six-word sentence, demonstrating six gestures according to instructions and naming them, and concluding by recalling as many words of the sentence as possible after a distraction. The validated PICNIR test consists of two parts. First, the patient names 20 black-and-white pictures. Then, the task is to recall and rewrite as many of the picture names as possible within one minute. Both tests allow for a quick and simultaneous assessment of speech and memory.
Delirium may develop in 10-30% of patients after a stroke. Post-stroke delirium may be associated with the development of cognitive impairment or dementia within three months to two years. These findings emphasize the importance of rapid detection and treatment of delirium post-stroke, as well as the monitoring of cognitive functions in subsequent years. Detecting delirium is crucial for the proper management of post-stroke care. Various tests have been developed for delirium detection. The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the Intensive Care Delirium Screening Checklist (ICDSC) are commonly used. The CAM-ICU test was designed for use by both doctors and nurses in intensive care settings and has already been validated in Czech for stroke patients. While the Czech version of the ICDSC has not been validated, foreign studies suggest it is a suitable tool for delirium detection. A survey among Czech neurological departments has highlighted the need for such tests.
The investigators aim to assess the usefulness of all four methods in clinical practice for patients after a stroke. Therefore, they have prepared a project to evaluate the benefits and utilization of cognitive tests ALBA and PICNIR, and delirium tests CAM-ICU and ICDSC, in the acute phase of stroke. Additionally, they aim to validate the very short ALBA and PICNIR tests, which take less than five minutes, to improve post-stroke care in the future.
- Conditions
- Stroke Acute
- Being tested
- Examination by a speech therapist, Cognitive examination, Examination of delirium, History taking
- Keywords
- stroke, kognitive function, delirium
- Medical subject headings
- Stroke, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination by a speech therapistOther
MASTcz test
Cognitive examinationDiagnostic test
ALBA test, PICNIR test
Examination of deliriumOther
CAM-ICU and ICDSC questionnaire
History takingOther
The first page includes several sections: personal information, pre-stroke history, time-related data, neurological deficit data, radiological evaluation, pre-admission and admission treatment, and a medical examination focused on motor and speech impairments. The third page will document the physician's delirium examination and the speech therapy assessment. A questionnaire will be given to the relatives or close persons of the patients to fill out in order to collect systematic personal and pre-stroke anamnestic data and to assess the presence of dementia signs before the stroke using the Blessed Dementia Scale (BDS) questionnaire. All pages of the record form and the Questionnaire for Relatives are included in the appendices.
| Study group | Role | What they receive |
|---|---|---|
| Patients with schemic or hemorrhagic CVA | Patients admitted to the monitored bed of the neurological ICU for ischemic or hemorrhagic CVA, with the possibility of an initial examination within 24 hours of admission (not the onset of CVA), and with an anticipated length of hospitalization longer than five days, will be included in the study. Receives: Other: Examination by a speech therapist; Diagnostic Test: Cognitive examination; Other: Examination of delirium; Other: History taking |
What is being measured
The primary outcome is the main question the study is designed to answer.
POBAV test
Speech disorders after a stroke will be easily and quickly detectable using the PICNIR test, which will express the degree of impairment using numerical scales.
In the PICNIR test, we evaluate the number of errors in pictures naming (the lower the better, preferably 0) and the number of correctly named pictures (the higher the better, max 16)
Measured: 1st day after a stroke, 5th day after a stroke
ALBA test
Description: Speech disorders after a stroke will be easily and quickly detectable using the ALBA test, which will express the degree of impairment using numerical scales.
ALBA score (0-12): the worst 0 and the best 12 points.
Measured: 1st day after a stroke, 5th day after a stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start3 Apr 2024
- Primary completion3 May 2025 (estimated)
- Study completion3 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke AcuteStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Magda Michalovová, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670716
- Sponsor's protocol ID
- EK-VP l05l00l2024
- Acronym
- COGISTROKE
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bartos A, Weinerova J, Diondet S. Effects of human probiotics on memory and psychological and physical measures in community-dwelling older adults with normal and mildly impaired cognition: results of a bi-center, double-blind, randomized, and placebo-controlled clinical trial (CleverAge biota). Front Aging Neurosci. 2023 Jul 7;15:1163727. doi: 10.3389/fnagi.2023.1163727. eCollection 2023.
PubMed 37502424Bartoš, A., Test ALBA byl uznán jako certifikovaná metodika Ministerstvem zdravotnictví ČR (2024) Ceska a Slovenska Neurologie a Neurochirurgie, 87 (3), p. 153.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VERY BRIEF SPEECH and MEMORY ASSESSMENTS USING ALBA a PICNIR TESTS and DELIRIUM ASSESSMENTS USING CAM-ICU and ICDSC TESTS in PATIENTS SHORTLY AFTER the STROKE
- ClinicalTrials.gov ID
- NCT06670716
- Acronym / sponsor ID
- COGISTROKE / EK-VP l05l00l2024
- Conditions
- Stroke Acute
- Keywords
- stroke, kognitive function, delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 3 May 2025 (estimated)
- Study completion
- 3 May 2026 (estimated)
- First posted
- 1 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.
The aim of the project is to validate the ALBA and PICNIR tests for the easy detection of memory and speech disorders in patients after a stroke. Patients, after their first stroke, with the possibility of initial clinical evaluation within 24 hours of admission to the Neurology Clinic ICU, will undergo a neurological examination, cognitive tests using the ALBA and PICNIR tests, delirium tests using the CAM-ICU and ICDSC tools, and a speech therapy test using the MASTcz tool. If possible, these will be conducted simultaneously in one half-day. A similar structured examination will take place within five days, with a tolerance of one day. Upon demonstrating utility, doctors will be able to utilize the very brief ALBA and POBAV methods for detecting memory and speech disorders in post-stroke patients in clinical practice.
Detailed description
Speech and motor production disorders are easily recognizable or examinable symptoms of stroke (Cerebrovascular Accident - CVA). In contrast, memory disorders are rarely examined, primarily within research studies rather than routine clinical practice, for several reasons. Fatigue-related disorders cause difficulties in memory and other cognitive function examinations. Aphasia is accompanied by cognitive deficits, which are not always easy to detect due to speech and motor impairments. Another reason is the scarcity of suitable tests that are brief yet informative. Since stroke patients are typically older, it can be assumed that memory disorders are frequent in this population. There is a bidirectional relationship between cognitive disorders and stroke. Cognitive impairment increases the risk of stroke and death, while post-stroke cognitive impairment may have existed before the stroke or may be partly caused by it. It can occur early or later after the event. Cognitive impairment persists in patients after a CVA, even after successful clinical recovery, and is closely related to poor functional outcomes.
Assessing cognitive impairment after a stroke is significant in both acute and chronic care. It helps to determine whether the patient remembers important information regarding their health status and recommendations for lifestyle changes (e.g., not smoking, adhering to a diabetic diet, regular blood pressure checks), as well as the use of essential treatments like antihypertensives or secondary preventive treatments-antiplatelet and anticoagulant therapy. Speech and memory disorders affect acute and chronic patient care-nursing, caregiving, rehabilitation, and speech therapy, as well as care in the home environment. Expressive aphasia is easily noticed, but often not quantified. Sensory aphasia is generally less recognizable from ordinary contact. The quality of the examination determines the extent of the disorder found. It is crucial for healthcare personnel to understand what to expect regarding collaboration. It is also essential to estimate whether the patient will understand the significance of the communicated information and how well they will cooperate during rehabilitation.
A physician can quickly and easily quantify speech and memory disorders after a stroke using the original Czech and innovative tests, Amnesia Light and Brief Assessment (ALBA) and Picture Naming and Immediate Recall (PICNIR). Although initially developed for patients with cognitive disorders or dementia, they are also well-suited for post-stroke patients. The validated ALBA test involves learning and repeating a six-word sentence, demonstrating six gestures according to instructions and naming them, and concluding by recalling as many words of the sentence as possible after a distraction. The validated PICNIR test consists of two parts. First, the patient names 20 black-and-white pictures. Then, the task is to recall and rewrite as many of the picture names as possible within one minute. Both tests allow for a quick and simultaneous assessment of speech and memory.
Delirium may develop in 10-30% of patients after a stroke. Post-stroke delirium may be associated with the development of cognitive impairment or dementia within three months to two years. These findings emphasize the importance of rapid detection and treatment of delirium post-stroke, as well as the monitoring of cognitive functions in subsequent years. Detecting delirium is crucial for the proper management of post-stroke care. Various tests have been developed for delirium detection. The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the Intensive Care Delirium Screening Checklist (ICDSC) are commonly used. The CAM-ICU test was designed for use by both doctors and nurses in intensive care settings and has already been validated in Czech for stroke patients. While the Czech version of the ICDSC has not been validated, foreign studies suggest it is a suitable tool for delirium detection. A survey among Czech neurological departments has highlighted the need for such tests.
The investigators aim to assess the usefulness of all four methods in clinical practice for patients after a stroke. Therefore, they have prepared a project to evaluate the benefits and utilization of cognitive tests ALBA and PICNIR, and delirium tests CAM-ICU and ICDSC, in the acute phase of stroke. Additionally, they aim to validate the very short ALBA and PICNIR tests, which take less than five minutes, to improve post-stroke care in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with schemic or hemorrhagic CVA | – | Other: Examination by a speech therapist, Diagnostic Test: Cognitive examination, Other: Examination of delirium, Other: History takingPatients admitted to the monitored bed of the neurological ICU for ischemic or hemorrhagic CVA, with the possibility of an initial examination within 24 hours of admission (not the onset of CVA), and with an anticipated length of hospitalization longer than five days, will be included in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to the monitored bed of the neurological ICU for ischemic or hemorrhagic CVA with the possibility of initial examination within 24 hours of admission (not the onset of CVA), with an anticipated length of hospitalization longer than five days, will be included in the study.
Key inclusion criteria (6 listed)
- Native speaker of the Czech Republic. Czech must be the patient\'s native language.
- Admission to the monitored bed of the neurological ICU with the possibility of initial examination within 24 hours of admission (not the onset of CVA).
- Anticipated length of hospitalization longer than five days.
- First clinical CVA in life. Subclinical signs of CVA on brain CT are acceptable.
- Absence of previous neurological deficit of any etiology affecting the brain, e.g., trauma, or spinal cord.
Key exclusion criteria (17 listed)
- Native speaker of the Czech Republic. Czech must be the patient\'s mother tongue.
- Admission to the monitored bed of the neurological ICU with the possibility of initial examination within 24 hours of admission (not the onset of CVA).
- Anticipated length of hospitalization longer than five days.
- First clinical CVA in life. Subclinical signs of CVA on brain CT are acceptable.
- Absence of previous neurological deficit of any etiology affecting the brain, e.g., trauma, or spinal cord.
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 |
|---|---|---|
| Examination by a speech therapistMASTcz test | Other | Patients with schemic or hemorrhagic CVA |
| Cognitive examinationALBA test, PICNIR test | Diagnostic test | Patients with schemic or hemorrhagic CVA |
| Examination of deliriumCAM-ICU and ICDSC questionnaire | Other | Patients with schemic or hemorrhagic CVA |
| History takingThe first page includes several sections: personal information, pre-stroke history, time-related data, neurological deficit data, radiological evaluation, pre-admission and admission treatment, and a medical examination focused on motor and speech impairments. The third page will document the physician's delirium examination and the speech therapy assessment. A questionnaire will be given to the relatives or close persons of the patients to fill out in order to collect systematic personal and pre-stroke anamnestic data and to assess the presence of dementia signs before the stroke using the Blessed Dementia Scale (BDS) questionnaire. All pages of the record form and the Questionnaire for Relatives are included in the appendices. | Other | Patients with schemic or hemorrhagic CVA |
Primary outcome
POBAV test
Time frame: 1st day after a stroke, 5th day after a stroke
Speech disorders after a stroke will be easily and quickly detectable using the PICNIR test, which will express the degree of impairment using numerical scales. In the PICNIR test, we evaluate the number of errors in pictures naming (the lower the better, preferably 0) and the number of correctly named pictures (the higher the better, max 16)
ALBA test
Time frame: 1st day after a stroke, 5th day after a stroke
Description: Speech disorders after a stroke will be easily and quickly detectable using the ALBA test, which will express the degree of impairment using numerical scales. ALBA score (0-12): the worst 0 and the best 12 points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 37502424Bartos A, Weinerova J, Diondet S. Effects of human probiotics on memory and psychological and physical measures in community-dwelling older adults with normal and mildly impaired cognition: results of a bi-center, double-blind, randomized, and placebo-controlled clinical trial (CleverAge biota). Front Aging Neurosci. 2023 Jul 7;15:1163727. doi: 10.3389/fnagi.2023.1163727. eCollection 2023.
- BackgroundBartoš, A., Test ALBA byl uznán jako certifikovaná metodika Ministerstvem zdravotnictví ČR (2024) Ceska a Slovenska Neurologie a Neurochirurgie, 87 (3), p. 153.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Acute, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
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 6 inclusion and 17 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 25 Feb 2025. 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 Czechia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POBAV test (time frame: 1st day after a stroke, 5th day after a stroke). The study lists 2 primary outcomes in all. 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 NCT06670716, which also lists 2 linked publications.
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 25 Feb 2025.