AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Czechia1 site
  • Fakultní Nemocnice Královské Vinohrady

    Prague, Prague

Other trials in Czechia

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 groups in NCT06670716
Study groupRoleWhat they receive
Patients with schemic or hemorrhagic CVAPatients 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.

  1. 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

  2. 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.

  1. First posted1 Nov 2024
  2. Study start3 Apr 2024
  3. Primary completion3 May 2025 (estimated)
  4. Study completion3 May 2026 (estimated)

Resources

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
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 37502424
  • Bartoš, A., Test ALBA byl uznán jako certifikovaná metodika Ministerstvem zdravotnictví ČR (2024) Ceska a Slovenska Neurologie a Neurochirurgie, 87 (3), p. 153.

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in