Clinical trial NCT06375902: The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them
Official title: The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Schizophrenia; Psychosis
Keywords: language
pragmatics
rehabilitation
electrophysiology
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 32 Schizophrenic patients and 32 healthy controls

Brief summary: Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique

Detailed description: The investigators will address the following objectives:

* Primary Objective: Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique
* Secondary Objectives: 1) Evaluate the interactions between performances in metaphor comprehension and individual differences in psychopathology, cognition, ToM and functioning; 2) Test if the altered neurophysiological patterns associated to the fragility of metaphor comprehension in schizophrenia can be restored through a rehabilitative training

The investigators will enroll 32 schizophrenic patients and 32 healthy subjects as control sample.

Participants will undergo an initial visit with a specialist psychiatrist who will verify that their conditions meet the criteria required by the study. Then, subjects will be tested for metaphor comprehension, as well as for the other variables included in the study, and the electrical brain activity will be registered through a 128 channel EEG.

In the check-up visits (i.e., after the training) the following data will be collected:

* Scores relating to cognitive, pragmatic (understanding of metaphors), theory of mind and global functioning performance scores
* EEG recordings related to the process of understanding metaphors
* Scores on scales that evaluate psychopathological severity

Eligibility criteria: Inclusion Criteria:

For patients:

* Age between 18 and 65 years
* Diagnosis of Schizophrenia according to DSM V criteria
* Ability to provide informed consent

For healthy controls:

* Age between 18 and 65 years
* Ability to provide informed consent
* Absence of psychiatric pathologies
* Ability to speak Italian

Exclusion Criteria:

For patients:

* Intellectual disability
* Neurological disorder

For healthy controls:

* Presence of psychiatric pathologies
* Difficulties in speaking Italian

Primary outcomes:
measure: Tracking down the difficulties in metaphor comprehension via a behavioural task
timeFrame: through study completion, an average of 2 years
measure: Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Evaluation of psychopathology
timeFrame: through study completion, an average of 2 years
measure: Evaluation of cognition
timeFrame: through study completion, an average of 2 years
measure: Evaluation of Theory of Mind
timeFrame: through study completion, an average of 2 years
measure: Evaluation of functioning
timeFrame: through study completion, an average of 2 years
measure: Evaluate the efficacy of a rehabilitative training in restoring metaphor comprehension ability
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: Vita-Salute San Raffaele University
name: Mart Bosia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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