BRIEF COGNITIVE and DELIRIUM ASSESSMENTS in STROKE PATIENTS

NCT06670716 | Active Not Recruiting

• 1 other identifier: EK-VP l05l00l2024
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stroke Acute

Keywords

stroke; kognitive function; delirium

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  1st day after a stroke, 5th day after a stroke

Study Arms (1)

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.

Other: Examination by a speech therapist; Diagnostic Test: Cognitive examination; Other: Examination of delirium; Other: History taking

Interventions

Examination by a speech therapist OTHER

MASTcz test

Patients with schemic or hemorrhagic CVA

Cognitive examination DIAGNOSTIC_TEST

ALBA test, PICNIR test

Patients with schemic or hemorrhagic CVA

Examination of delirium OTHER

CAM-ICU and ICDSC questionnaire

Patients with schemic or hemorrhagic CVA

History taking OTHER

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.

Patients with schemic or hemorrhagic CVA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead

Study Sites (1)

Fakultní Nemocnice Královské Vinohrady

Prague, Prague, Czechia

Location

Related Publications (2)

• 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.

  PMID: 37502424 BACKGROUND

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

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Stroke; Delirium

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: November 1, 2024
• Study Start: April 3, 2024
• Primary Completion: May 3, 2025
• Study Completion: May 3, 2026
• Last Updated: February 25, 2025

Record last verified: 2024-07

Locations

CZ (1)