Schizophrenia; PsychosisFRAMENCT06375902
The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them
An observational study of Schizophrenia; Psychosis, run by IRCCS San Raffaele at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia; Psychosis
- What is being tested?
- PragmaCom
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jul 2024to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 32 Schizophrenic patients and 32 healthy controls
Who may be able to join
- 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
Show all 9Show fewer
- Ability to provide informed consent
- Absence of psychiatric pathologies
- Ability to speak Italian
Who cannot join
- For patients:
- Intellectual disability
- Neurological disorder
- For healthy controls:
- Presence of psychiatric pathologies
- Difficulties in speaking Italian
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Schizophrenia; Psychosis
- Being tested
- PragmaCom
- Keywords
- language, pragmatics, rehabilitation, electrophysiology
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PragmaComBehavioural
Cognitive behavioral intervention targeting the ability to understand metaphors
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PragmaCom | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, an average of 2 years
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.
Measured: through study completion, an average of 2 years
Secondary outcomes (5)
Evaluation of psychopathology
Evaluate psychopathology with the Positive and Negative Syndrome scale (PANSS) (range values 30-210, higher scores mean a worse outcome).
Measured: through study completion, an average of 2 years
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).
Measured: through study completion, an average of 2 years
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).
Measured: through study completion, an average of 2 years
Evaluation of functioning
Evaluate functioning, with the Quality of life scale (QLS) (range score 0-126, higher scores mean a better outcome).
Measured: through study completion, an average of 2 years
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).
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start12 Jul 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Bosia, IRCCS San Raffaele
- Investigators
- Mart Bosia, MD, PhD, Principal investigator, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375902
- Sponsor's protocol ID
- 2022289RNA
- Acronym
- FRAME
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35526293Thoma 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.
PubMed 17079014Harvey PD, Bowie CR, Friedman JI. Cognition in schizophrenia. Curr Psychiatry Rep. 2001 Oct;3(5):423-8. doi: 10.1007/s11920-996-0038-7.
PubMed 11559481Rossetti 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.
PubMed 29867648Rapp 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.
PubMed 29354082Bambini 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.
PubMed 31923528Mossaheb 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.
PubMed 24556517Bambini 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.
PubMed 27199799De 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.
PubMed 20307557Iakimova 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.
PubMed 16008767Adamczyk 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.
PubMed 33973137Bambini 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.
PubMed 33137591
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them
- ClinicalTrials.gov ID
- NCT06375902
- Acronym / sponsor ID
- FRAME / 2022289RNA
- Conditions
- Schizophrenia; Psychosis
- Keywords
- language, pragmatics, rehabilitation, electrophysiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia group | – | Behavioral: PragmaComWe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 32 Schizophrenic patients and 32 healthy controls
Key inclusion criteria (9 listed)
- Age between 18 and 65 years
- Diagnosis of Schizophrenia according to DSM V criteria
- Ability to provide informed consent
- Age between 18 and 65 years
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Intellectual disability
- Neurological disorder
- Presence of psychiatric pathologies
- Difficulties in speaking Italian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PragmaComCognitive behavioral intervention targeting the ability to understand metaphors | Behavioural | Schizophrenia group |
Primary outcome
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).
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.
5 secondary outcomes
Evaluation of psychopathology
Time frame: through study completion, an average of 2 years
Evaluation of cognition
Time frame: through study completion, an average of 2 years
Evaluation of Theory of Mind
Time frame: through study completion, an average of 2 years
Evaluation of functioning
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Background: PubMed 35526293Bambini 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.
- Background: PubMed 17079014Thoma 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.
- Background: PubMed 11559481Harvey PD, Bowie CR, Friedman JI. Cognition in schizophrenia. Curr Psychiatry Rep. 2001 Oct;3(5):423-8. doi: 10.1007/s11920-996-0038-7.
- Background: PubMed 29867648Rossetti 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.
- Background: PubMed 29354082Rapp 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.
- Background: PubMed 31923528Bambini 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.
- Background: PubMed 24556517Mossaheb 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.
- Background: PubMed 27199799Bambini 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.
- Background: PubMed 20307557De 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.
- Background: PubMed 16008767Iakimova 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.
- Background: PubMed 33973137Adamczyk 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.
- Background: PubMed 33137591Bambini 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mart Bosia, MD, PhD principal investigator
Università Vita-Salute San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia; Psychosis, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracking down the difficulties in metaphor comprehension via a behavioural task (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06375902, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.