The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them (FRAME)

January 21, 2025 updated by: Marta Bosia, IRCCS San Raffaele
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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20100
        • IRCCS San Raffaele

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

32 Schizophrenic patients and 32 healthy controls

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Schizophrenia group

We will enroll 32 patients selected according to the presence of Schizophrenia diagnosis (DSM V criteria), which 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.

Patients will be assigned either to a rehabilitative training (PragmaCom), or to a standard rehabilitative program to test if the altered neurophysiological patterns associated to the fragility of metaphor comprehension in schizophrenia can be restored.
Behavioral: PragmaCom
Cognitive behavioral intervention targeting the ability to understand metaphors
Healthy controls group
32 healthy subjects, as control sample, that 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tracking down the difficulties in metaphor comprehension via a behavioural task
Time Frame: through study completion, an average of 2 years
Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia compared to healthy controls across different metaphor types through the Physical and mental metaphor task (PMM) (range values 0-28, higher scores mean a better outcome).
through study completion, an average of 2 years
Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording
Time Frame: through study completion, an average of 2 years
Exploring the difference in the neurological correlates (via electrophysiological recording technique) between patients and controls. Electrophysiological indexes that will be evaluated are event-related potential after the stimulus presentation.
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of psychopathology
Time Frame: through study completion, an average of 2 years
Evaluate psychopathology with the Positive and Negative Syndrome scale (PANSS) (range values 30-210, higher scores mean a worse outcome).
through study completion, an average of 2 years
Evaluation of cognition
Time Frame: through study completion, an average of 2 years
Evaluate cognition in schizophrenia with the Brief assessement of cognition in schizophrenia (BACS) (range total score 0-1, higher scores mean a better outcome).
through study completion, an average of 2 years
Evaluation of Theory of Mind
Time Frame: through study completion, an average of 2 years
Evaluate Theory of Mind with the Picture sequencing task (PST) (range score 0-56, higher scores mean a better outcome).
through study completion, an average of 2 years
Evaluation of functioning
Time Frame: through study completion, an average of 2 years
Evaluate functioning, with the Quality of life scale (QLS) (range score 0-126, higher scores mean a better outcome).
through study completion, an average of 2 years
Evaluate the efficacy of a rehabilitative training in restoring metaphor comprehension ability
Time Frame: through study completion, an average of 2 years
Test te improvement of metaphor comprehension, evaluated with the Physical and mental metaphor task (PMM) (range values 0-28, higher scores mean a better outcome).
through study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Mart Bosia, MD, PhD, Vita-Salute San Raffaele University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 12, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022289RNA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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