Social Cognition and Language in Patients With Gliomas

May 16, 2023 updated by: University Medical Center Groningen

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

Not yet recruiting

Study Type

Observational

Enrollment (Anticipated)

105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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