- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05764460
Social Cognition and Language in Patients With Gliomas
Social Cognition and Language in Patients With Gliomas: Putting Feelings Into Words
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impairments in emotion recognition
Time Frame: 10 minutes
|
FEEST
|
10 minutes
|
|
Impairments in Theory of Mind
Time Frame: 10 minutes
|
Cartoons
|
10 minutes
|
|
Impairments in social insight
Time Frame: 10 minutes
|
Faux Pas
|
10 minutes
|
|
Impairments in phonology, semantics, syntaxis
Time Frame: 10 minutes (total NPA approximately 3 hours)
|
Screeling
|
10 minutes (total NPA approximately 3 hours)
|
|
Impairments in naming
Time Frame: 5 minutes (total NPA approximately 3 hours)
|
Boston Naming Test
|
5 minutes (total NPA approximately 3 hours)
|
|
Impairments in fluency
Time Frame: 5 minutes (total NPA approximately 3 hours)
|
Fluency
|
5 minutes (total NPA approximately 3 hours)
|
|
Impairments in language comprehension
Time Frame: 5 minutes (total NPA approximately 3 hours)
|
SAN
|
5 minutes (total NPA approximately 3 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impairments in memory
Time Frame: 10 minutes (total NPA approximately 3 hours)
|
Rivermead Behavioral Memory Test
|
10 minutes (total NPA approximately 3 hours)
|
|
Impairments in executive functions
Time Frame: 2 minutes (total NPA approximately 3 hours)
|
Key Search
|
2 minutes (total NPA approximately 3 hours)
|
|
Impairments in speed and attention
Time Frame: 5 minutes (total NPA approximately 3 hours)
|
Trail Making Test
|
5 minutes (total NPA approximately 3 hours)
|
|
Impairments in structured spontaneous language
Time Frame: 5 minutes (total NPO approximately 3 hours)
|
Cookie Theft
|
5 minutes (total NPO approximately 3 hours)
|
|
Impairments in general language
Time Frame: 5 minutes (total NPO approximately 3 hours)
|
QUEST-NL
|
5 minutes (total NPO approximately 3 hours)
|
|
Impairments in unstructured spontaneous language
Time Frame: 5 minutes (total NPO approximately 3 hours)
|
Story telling
|
5 minutes (total NPO approximately 3 hours)
|
|
Empathy
Time Frame: Approximately 3 minutes
|
Questionnaire filled in by patient and proxy: IRI
|
Approximately 3 minutes
|
|
Social abilities
Time Frame: Approximately 3 minutes
|
Questionnaire filled in by patient and proxy: DEX
|
Approximately 3 minutes
|
|
Relationship quality
Time Frame: Approximately 4 minutes
|
Questionnaire filled in by patient and proxy: CSI
|
Approximately 4 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11351 (DAIDS ES)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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