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

Schizophrenia; Psychosis Clinical Trial

— FRAME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375902
• Other study ID #: 2022289RNA
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: IRCCS San Raffaele
• Contact: Mart Bosia, MD, PhD
• Phone: 00390226433299
• Email: bosia.marta[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia; Psychosis

Intervention

Behavioral:
• PragmaCom
Cognitive behavioral intervention targeting the ability to understand metaphors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

References & Publications (12)

Adamczyk P, Jani M, Ligeza TS, Plonka O, Bladzinski P, Wyczesany M. On the Role of Bilateral Brain Hypofunction and Abnormal Lateralization of Cortical Information Flow as Neural Underpinnings of Conventional Metaphor Processing Impairment in Schizophrenia: An fMRI and EEG Study. Brain Topogr. 2021 Jul;34(4):537-554. doi: 10.1007/s10548-021-00849-x. Epub 2021 May 10. — View Citation

Bambini V, Agostoni G, Buonocore M, Tonini E, Bechi M, Ferri I, Sapienza J, Martini F, Cuoco F, Cocchi F, Bischetti L, Cavallaro R, Bosia M. It is time to address language disorders in schizophrenia: A RCT on the efficacy of a novel training targeting the pragmatics of communication (PragmaCom). J Commun Disord. 2022 May-Jun;97:106196. doi: 10.1016/j.jcomdis.2022.106196. Epub 2022 Feb 2. — View Citation

Bambini V, Arcara G, Bosinelli F, Buonocore M, Bechi M, Cavallaro R, Bosia M. A leopard cannot change its spots: A novel pragmatic account of concretism in schizophrenia. Neuropsychologia. 2020 Mar 2;139:107332. doi: 10.1016/j.neuropsychologia.2020.107332. Epub 2020 Jan 7. — View Citation

Bambini V, Bertini C, Schaeken W, Stella A, Di Russo F. Disentangling Metaphor from Context: An ERP Study. Front Psychol. 2016 May 3;7:559. doi: 10.3389/fpsyg.2016.00559. eCollection 2016. — View Citation

Bambini V, Tonini E, Ceccato I, Lecce S, Marocchini E, Cavallini E. How to improve social communication in aging: Pragmatic and cognitive interventions. Brain Lang. 2020 Dec;211:104864. doi: 10.1016/j.bandl.2020.104864. Epub 2020 Nov 1. — View Citation

De Grauwe S, Swain A, Holcomb PJ, Ditman T, Kuperberg GR. Electrophysiological insights into the processing of nominal metaphors. Neuropsychologia. 2010 Jun;48(7):1965-84. doi: 10.1016/j.neuropsychologia.2010.03.017. Epub 2010 Mar 20. — View Citation

Harvey PD, Bowie CR, Friedman JI. Cognition in schizophrenia. Curr Psychiatry Rep. 2001 Oct;3(5):423-8. doi: 10.1007/s11920-996-0038-7. — View Citation

Iakimova G, Passerieux C, Laurent JP, Hardy-Bayle MC. ERPs of metaphoric, literal, and incongruous semantic processing in schizophrenia. Psychophysiology. 2005 Jul;42(4):380-90. doi: 10.1111/j.1469-8986.2005.00303.x. — View Citation

Mossaheb N, Aschauer HN, Stoettner S, Schmoeger M, Pils N, Raab M, Willinger U. Comprehension of metaphors in patients with schizophrenia-spectrum disorders. Compr Psychiatry. 2014 May;55(4):928-37. doi: 10.1016/j.comppsych.2013.12.021. Epub 2014 Jan 14. — View Citation

Rapp AM, Felsenheimer AK, Langohr K, Klupp M. The Comprehension of Familiar and Novel Metaphoric Meanings in Schizophrenia: A Pilot Study. Front Psychol. 2018 Jan 5;8:2251. doi: 10.3389/fpsyg.2017.02251. eCollection 2017. — View Citation

Rossetti I, Brambilla P, Papagno C. Metaphor Comprehension in Schizophrenic Patients. Front Psychol. 2018 May 9;9:670. doi: 10.3389/fpsyg.2018.00670. eCollection 2018. — View Citation

Thoma P, Daum I. Neurocognitive mechanisms of figurative language processing--evidence from clinical dysfunctions. Neurosci Biobehav Rev. 2006;30(8):1182-205. doi: 10.1016/j.neubiorev.2006.09.001. Epub 2006 Oct 31. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tracking down the difficulties in metaphor comprehension via a behavioural task	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
Primary	Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording	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	Evaluation of psychopathology	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
Secondary	Evaluation of cognition	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
Secondary	Evaluation of Theory of Mind	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
Secondary	Evaluation of functioning	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
Secondary	Evaluate the efficacy of a rehabilitative training in restoring metaphor comprehension ability	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