Clinical trial NCT05764460: Social Cognition and Language in Patients With Gliomas
Official title: Social Cognition and Language in Patients With Gliomas: Putting Feelings Into Words
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma, Malignant
Cognitive Dysfunction
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a radiologically suspected glioma, referred for surgery (resection or biopt) in the UMCG, department of Neurosurgery, are eligible for inclusion.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Impairments in emotion recognition
timeFrame: 10 minutes
measure: Impairments in Theory of Mind
timeFrame: 10 minutes
measure: Impairments in social insight
timeFrame: 10 minutes
measure: Impairments in phonology, semantics, syntaxis
timeFrame: 10 minutes (total NPA approximately 3 hours)
measure: Impairments in naming
timeFrame: 5 minutes (total NPA approximately 3 hours)
measure: Impairments in fluency
timeFrame: 5 minutes (total NPA approximately 3 hours)
measure: Impairments in language comprehension
timeFrame: 5 minutes (total NPA approximately 3 hours)
Secondary outcomes:
measure: Impairments in memory
timeFrame: 10 minutes (total NPA approximately 3 hours)
measure: Impairments in executive functions
timeFrame: 2 minutes (total NPA approximately 3 hours)
measure: Impairments in speed and attention
timeFrame: 5 minutes (total NPA approximately 3 hours)
measure: Impairments in structured spontaneous language
timeFrame: 5 minutes (total NPO approximately 3 hours)
measure: Impairments in general language
timeFrame: 5 minutes (total NPO approximately 3 hours)
measure: Impairments in unstructured spontaneous language
timeFrame: 5 minutes (total NPO approximately 3 hours)
measure: Empathy
timeFrame: Approximately 3 minutes
measure: Social abilities
timeFrame: Approximately 3 minutes
measure: Relationship quality
timeFrame: Approximately 4 minutes
Other outcomes:
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