Cognitive Dysfunction Clinical Trial
Official title:
Social Cognition and Language in Patients With Gliomas: Putting Feelings Into Words
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 |
Verified date | May 2023 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
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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