Glioma, MalignantNCT05764460
Social Cognition and Language in Patients With Gliomas
An observational study of Glioma, Malignant and Cognitive Dysfunction, run by University Medical Center Groningen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Malignant, Cognitive Dysfunction
- What is being tested?
- Neuropsychological tests
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Glioma, Malignant, Cognitive Dysfunction
- Being tested
- Neuropsychological tests
- Medical subject headings
- Glioma, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsDiagnostic test
Neuropsychological tests for general cognition, social cognition and language.
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairments in emotion recognition
FEEST
Measured: 10 minutes
Impairments in Theory of Mind
Cartoons
Measured: 10 minutes
Impairments in social insight
Faux Pas
Measured: 10 minutes
Impairments in phonology, semantics, syntaxis
Screeling
Measured: 10 minutes (total NPA approximately 3 hours)
Impairments in naming
Boston Naming Test
Measured: 5 minutes (total NPA approximately 3 hours)
Impairments in fluency
Fluency
Measured: 5 minutes (total NPA approximately 3 hours)
Impairments in language comprehension
SAN
Measured: 5 minutes (total NPA approximately 3 hours)
Secondary outcomes (9)
Impairments in memory
Rivermead Behavioral Memory Test
Measured: 10 minutes (total NPA approximately 3 hours)
Impairments in executive functions
Key Search
Measured: 2 minutes (total NPA approximately 3 hours)
Impairments in speed and attention
Trail Making Test
Measured: 5 minutes (total NPA approximately 3 hours)
Impairments in structured spontaneous language
Cookie Theft
Measured: 5 minutes (total NPO approximately 3 hours)
Impairments in general language
QUEST-NL
Measured: 5 minutes (total NPO approximately 3 hours)
Impairments in unstructured spontaneous language
Story telling
Measured: 5 minutes (total NPO approximately 3 hours)
Empathy
Questionnaire filled in by patient and proxy: IRI
Measured: Approximately 3 minutes
Social abilities
Questionnaire filled in by patient and proxy: DEX
Measured: Approximately 3 minutes
Relationship quality
Questionnaire filled in by patient and proxy: CSI
Measured: Approximately 4 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MalignantStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764460
- Sponsor's protocol ID
- 11351
- Status last verified
- May 2023
- First submitted
- 25 Jan 2023
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition and Language in Patients With Gliomas: Putting Feelings Into Words
- ClinicalTrials.gov ID
- NCT05764460
- Acronym / sponsor ID
- 11351
- Conditions
- Glioma, Malignant, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testsNeuropsychological tests for general cognition, social cognition and language. | Diagnostic test | – |
Primary outcome
Impairments in emotion recognition
Time frame: 10 minutes
FEEST
Impairments in Theory of Mind
Time frame: 10 minutes
Cartoons
Impairments in social insight
Time frame: 10 minutes
Faux Pas
Impairments in phonology, semantics, syntaxis
Time frame: 10 minutes (total NPA approximately 3 hours)
Screeling
Impairments in naming
Time frame: 5 minutes (total NPA approximately 3 hours)
Boston Naming Test
Impairments in fluency
Time frame: 5 minutes (total NPA approximately 3 hours)
Fluency
Impairments in language comprehension
Time frame: 5 minutes (total NPA approximately 3 hours)
SAN
9 secondary outcomes
Impairments in memory
Time frame: 10 minutes (total NPA approximately 3 hours)
Impairments in executive functions
Time frame: 2 minutes (total NPA approximately 3 hours)
Impairments in speed and attention
Time frame: 5 minutes (total NPA approximately 3 hours)
Impairments in structured spontaneous language
Time frame: 5 minutes (total NPO approximately 3 hours)
Impairments in general language
Time frame: 5 minutes (total NPO approximately 3 hours)
Impairments in unstructured spontaneous language
Time frame: 5 minutes (total NPO approximately 3 hours)
Empathy
Time frame: Approximately 3 minutes
Social abilities
Time frame: Approximately 3 minutes
Relationship quality
Time frame: Approximately 4 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, Malignant and Cognitive Dysfunction, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impairments in emotion recognition (time frame: 10 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.