Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT06375902
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-24
First Post:
2024-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D007802', 'term': 'Language'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tracking down the difficulties in metaphor comprehension via a behavioural task', 'timeFrame': 'through study completion, an average of 2 years', 'description': '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).'}, {'measure': 'Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording', 'timeFrame': 'through study completion, an average of 2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of psychopathology', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Evaluate psychopathology with the Positive and Negative Syndrome scale (PANSS) (range values 30-210, higher scores mean a worse outcome).'}, {'measure': 'Evaluation of cognition', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Evaluate cognition in schizophrenia with the Brief assessement of cognition in schizophrenia (BACS) (range total score 0-1, higher scores mean a better outcome).'}, {'measure': 'Evaluation of Theory of Mind', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Evaluate Theory of Mind with the Picture sequencing task (PST) (range score 0-56, higher scores mean a better outcome).'}, {'measure': 'Evaluation of functioning', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Evaluate functioning, with the Quality of life scale (QLS) (range score 0-126, higher scores mean a better outcome).'}, {'measure': 'Evaluate the efficacy of a rehabilitative training in restoring metaphor comprehension ability', 'timeFrame': 'through study completion, an average of 2 years', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['language', 'pragmatics', 'rehabilitation', 'electrophysiology'], 'conditions': ['Schizophrenia; Psychosis']}, 'referencesModule': {'references': [{'pmid': '35526293', 'type': 'BACKGROUND', '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.'}, {'pmid': '17079014', 'type': 'BACKGROUND', '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.'}, {'pmid': '11559481', 'type': 'BACKGROUND', '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.'}, {'pmid': '29867648', 'type': 'BACKGROUND', '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.'}, {'pmid': '29354082', 'type': 'BACKGROUND', '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.'}, {'pmid': '31923528', 'type': 'BACKGROUND', '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.'}, {'pmid': '24556517', 'type': 'BACKGROUND', '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.'}, {'pmid': '27199799', 'type': 'BACKGROUND', '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.'}, {'pmid': '20307557', 'type': 'BACKGROUND', '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.'}, {'pmid': '16008767', 'type': 'BACKGROUND', '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.'}, {'pmid': '33973137', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33137591', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'The investigators will address the following objectives:\n\n* 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\n* 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\n\nThe investigators will enroll 32 schizophrenic patients and 32 healthy subjects as control sample.\n\nParticipants 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.\n\nIn the check-up visits (i.e., after the training) the following data will be collected:\n\n* Scores relating to cognitive, pragmatic (understanding of metaphors), theory of mind and global functioning performance scores\n* EEG recordings related to the process of understanding metaphors\n* Scores on scales that evaluate psychopathological severity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '32 Schizophrenic patients and 32 healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor patients:\n\n* Age between 18 and 65 years\n* Diagnosis of Schizophrenia according to DSM V criteria\n* Ability to provide informed consent\n\nFor healthy controls:\n\n* Age between 18 and 65 years\n* Ability to provide informed consent\n* Absence of psychiatric pathologies\n* Ability to speak Italian\n\nExclusion Criteria:\n\nFor patients:\n\n* Intellectual disability\n* Neurological disorder\n\nFor healthy controls:\n\n* Presence of psychiatric pathologies\n* Difficulties in speaking Italian'}, 'identificationModule': {'nctId': 'NCT06375902', 'acronym': 'FRAME', 'briefTitle': 'The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them', 'orgStudyIdInfo': {'id': '2022289RNA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Schizophrenia group', 'description': '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.\n\nPatients 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.', 'interventionNames': ['Behavioral: PragmaCom']}, {'label': 'Healthy controls group', 'description': '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.'}], 'interventions': [{'name': 'PragmaCom', 'type': 'BEHAVIORAL', 'description': 'Cognitive behavioral intervention targeting the ability to understand metaphors', 'armGroupLabels': ['Schizophrenia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Mart Bosia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vita-Salute San Raffaele University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.ssa', 'investigatorFullName': 'Marta Bosia', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}