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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05764460
Other study ID # 11351
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date June 1, 2025

Study information

Verified date May 2023
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with gliomas often suffer from lower quality of life, and detrimental social interactions after diagnosis. Two cognitive processes are crucial for maintaining healthy social relationships and interacting with others: social cognition and language. Social cognition is the ability to recognize and process mental and emotional states and to react appropriately in social situations. Social cognition and language are separate cognitive functions that can be affected in different ways in patients with brain injury. Also, distinct cognitive measurement instruments are used to assess both processes. However, there appears to be a certain overlap between social cognition and language. Reacting adequately in social situations requires both verbal and non-verbal communication and to communicate feelings, thoughts and intentions, people often use language. That is, verbal communication is part of a symbolic system that makes social interaction possible. Therefore, language abilities seem to be important to social cognition. Research shows that language is frequently impaired in adult patients with gliomas. Importantly, recent evidence suggests that social cognition can also be impaired in this patient group. However, no studies have been conducted into the relationship between social cognition and language in patients with gliomas. Increasing knowledge on the overlap between both functions, more specifically the influence of language difficulties on social cognition, will improve diagnostic accuracy. Eventually, this will lead to better, tailor-made treatments for these problems that negatively affect daily functioning. Objective: The main research objective is to examine the influence of language impairments on different social cognition processes, i.e., emotion recognition, Theory of Mind (ToM) and affective empathy, in patients with (suspected) gliomas. Secondary objectives are 1) to determine if patients with gliomas show impairments in different aspects of social cognition, i.e. emotion recognition, ToM, empathy and self-awareness; 2) to assess specific language impairments by looking at item-level characteristics of language tasks (e.g., analyses of word properties of fluency tasks, errors during object naming or spontaneous speech), and 3) to determine which tumor characteristics (low- or high-grade, genetic mutation, tumor location) are associated with different aspects of language and social cognition.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 105
Est. completion date June 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with suspected gliomas, i.e. low- or high-grade gliomas. - Age older than 18 years - Sufficient command of the Dutch language - Being able to understand the instructions of the NPA and to mentally and physically sustain/endure the assessment; this will be assessed in a consultation between treating physician (neurosurgeon) and investigator (neuropsychologist). Exclusion Criteria: - Serious neurodegenerative or psychiatric conditions (including addiction) - Serious (other) medical conditions or physical inability hindering patients to come to the hospital - Patients who need to undergo emergency craniotomy due to progression of disease

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Neuropsychological tests
Neuropsychological tests for general cognition, social cognition and language.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Outcome

Type Measure Description Time frame Safety issue
Primary Impairments in emotion recognition FEEST 10 minutes
Primary Impairments in Theory of Mind Cartoons 10 minutes
Primary Impairments in social insight Faux Pas 10 minutes
Primary Impairments in phonology, semantics, syntaxis Screeling 10 minutes (total NPA approximately 3 hours)
Primary Impairments in naming Boston Naming Test 5 minutes (total NPA approximately 3 hours)
Primary Impairments in fluency Fluency 5 minutes (total NPA approximately 3 hours)
Primary Impairments in language comprehension SAN 5 minutes (total NPA approximately 3 hours)
Secondary Impairments in memory Rivermead Behavioral Memory Test 10 minutes (total NPA approximately 3 hours)
Secondary Impairments in executive functions Key Search 2 minutes (total NPA approximately 3 hours)
Secondary Impairments in speed and attention Trail Making Test 5 minutes (total NPA approximately 3 hours)
Secondary Impairments in structured spontaneous language Cookie Theft 5 minutes (total NPO approximately 3 hours)
Secondary Impairments in general language QUEST-NL 5 minutes (total NPO approximately 3 hours)
Secondary Impairments in unstructured spontaneous language Story telling 5 minutes (total NPO approximately 3 hours)
Secondary Empathy Questionnaire filled in by patient and proxy: IRI Approximately 3 minutes
Secondary Social abilities Questionnaire filled in by patient and proxy: DEX Approximately 3 minutes
Secondary Relationship quality Questionnaire filled in by patient and proxy: CSI Approximately 4 minutes
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