Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective

Aphasia Clinical Trial

Official title:

Cognitive Functioning Profiles in Adults With Neurologically Recognized Aphasic Syndromes and General Population From a Biopsychosocial Perspective

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365658
• Other study ID #: 2024/PTPiP/1
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Aphasia
• Development, Human
• Neuropathology

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