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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06365658
Other study ID # 2024/PTPiP/1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 3, 2023
Est. completion date December 2025

Study information

Verified date April 2024
Source Laboratory of Psychological and Educational Tests
Contact Rafal Nowicki, M.A.
Phone +48509805591
Email nowicki@pracowniatestow.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to investigate cognitive functioning profiles in adults with neurologically recognized aphasic syndromes and general population. The study group consist of minimal 600 adults (over 18 y.o.) who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: memory, learning and language. Furthermore informations regarding past and present health condition will be collected from participants. The main questions it aims to answer are: 1. What is the profile of memory and learning among polish adults? 2. Do gender and age moderates patterns of memory and learning functioning among polish adults? 3. What is a specific pattern of language functioning in adults with neurologically recognized aphasic syndromes? 4. Do gender moderates specific patterns of language functioning in adults with neurologically recognized aphasic syndromes? Researchers will compare the following groups of adults: 1. general population/control group 2. with neurologically recognized aphasic syndromes 3. seniors (over 60 y.o.)


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 2025
Est. primary completion date March 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria for general population/control group: - age from 18 to 60 y.o. Inclusion criteria for neurologically recognized aphasic syndromes - age above 18 y.o. - neurologically recognized aphasic syndromes Inclusion criteria for seniors: - age above 60 y.o. Exclusion criteria for general population/control group: - age less then 18 y.o. - neurologically recognized aphasic syndromes Exclusion criteria for neurologically recognized aphasic syndromes - age less then 18 y.o. - no neurologically recognized aphasic syndromes Exclusion criteria for seniors - age less then 60 y.o. - diseases of the nervous system, such as: stroke, craniocerebral trauma, neuroinfections, neurodegenerative diseases - mental disorders such as depression, psychotic disorders, anxiety disorders, addictions

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Psychological assessment
Psychological assessment of memory, learning and language

Locations

Country Name City State
Poland Laboratory of Psychological and Educational Tests Gdansk Pomerania

Sponsors (1)

Lead Sponsor Collaborator
Bartosz M. Radtke

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Memory and learning Test of Memory and Learning (second edition). A standardized test measuring memory functioning and learning abilities. The test includes four basic factors (Verbal Memory, Nonverbal Memory, Complex Memory, and Delayed Recall) and five supplementary factors (Attention/Concentration, Sequential Memory, Free Recall, Associative Recall and Learning). The raw scores obtained in each tested subscale are converted into scores scaled based on age norms, ranging from 1 to 20, where a higher score means better functioning of the examined area, and a lower result means poorer functioning. July 3, 2023 until March 31, 2025
Primary Language Boston Diagnostic Aphasia Examination-Third Edition. A spectrum of tools that helps to identify and distinguish among disorders of language function and neurologically recognized aphasic syndromes. The test have five functional subsections: 1) Conversational and Expository Speech, 2) Auditory Comprehension, 3) Oral Expression, 4) Reading and 5) Writing. The raw scores obtained in each tested subscale are converted into a percentile scale, ranging from 1 to 100, where a higher score means better functioning of the examined area, and a lower result means poorer functioning. July 3, 2023 until March 31, 2025
Primary Socio-demographic data Author's survey of socio-demographic data, including: gender, month and year of birth, region of residence July 3, 2023 until March 31, 2025
Secondary General mental state Mini-Mental State Examination. A clinical scale used to examine disorders in a patient's cognitive functioning. The questionnaire consists a series of questions allowing the assessment of the following functions: 1) orientation in time and place, 2) attention/concentration, 3) short-term memory (recall), 4) language skills, 5) visual-spatial abilities, 6) ability to understand and follow the instructions. The maximum score that can be obtained on the test is 30 points. 27-30 is a correct result; 24-26 is a cognitive impairment without dementia; 19-23 mean mild dementia; 11-18 is a moderate degree dementia and 0-10 mean profound dementia. July 3, 2023 until March 31, 2025
Secondary Health related data Author's survey of health related data, including: hearing, eyesight, hypertension, atherosclerosis, previous heart attack, diabetes, endocrine diseases, respiratory system diseases, musculoskeletal system diseases, nervous system diseases, kidney diseases, sleep disorders, hospitalizations, procedures under general anesthesia, cancer, medications. July 3, 2023 until March 31, 2025
Secondary Education data Author's survey of education, including: years of education, level of education, occupation, level of education of the participant's parents. July 3, 2023 until March 31, 2025
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