NCT05764460

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

January 25, 2023

Last Update Submit

May 16, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Impairments in emotion recognition

    FEEST

    10 minutes

  • Impairments in Theory of Mind

    Cartoons

    10 minutes

  • Impairments in social insight

    Faux Pas

    10 minutes

  • Impairments in phonology, semantics, syntaxis

    Screeling

    10 minutes (total NPA approximately 3 hours)

  • Impairments in naming

    Boston Naming Test

    5 minutes (total NPA approximately 3 hours)

  • Impairments in fluency

    Fluency

    5 minutes (total NPA approximately 3 hours)

  • Impairments in language comprehension

    SAN

    5 minutes (total NPA approximately 3 hours)

Secondary Outcomes (9)

  • Impairments in memory

    10 minutes (total NPA approximately 3 hours)

  • Impairments in executive functions

    2 minutes (total NPA approximately 3 hours)

  • Impairments in speed and attention

    5 minutes (total NPA approximately 3 hours)

  • Impairments in structured spontaneous language

    5 minutes (total NPO approximately 3 hours)

  • Impairments in general language

    5 minutes (total NPO approximately 3 hours)

  • +4 more secondary outcomes

Interventions

Neuropsychological tests for general cognition, social cognition and language.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GliomaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

March 10, 2023

Study Start

July 1, 2023

Primary Completion

March 1, 2025

Study Completion

June 1, 2025

Last Updated

May 17, 2023

Record last verified: 2023-05