NCT06375902

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 12, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

January 24, 2025

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

March 15, 2024

Last Update Submit

January 21, 2025

Conditions

Keywords

languagepragmaticsrehabilitationelectrophysiology

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Evaluation of psychopathology

    through study completion, an average of 2 years

  • Evaluation of cognition

    through study completion, an average of 2 years

  • Evaluation of Theory of Mind

    through study completion, an average of 2 years

  • Evaluation of functioning

    through study completion, an average of 2 years

  • Evaluate the efficacy of a rehabilitative training in restoring metaphor comprehension ability

    through study completion, an average of 2 years

Study Arms (2)

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

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.

Interventions

PragmaComBEHAVIORAL

Cognitive behavioral intervention targeting the ability to understand metaphors

Schizophrenia group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

32 Schizophrenic patients and 32 healthy controls

You may qualify if:

  • 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

You may not qualify if:

  • For patients:
  • Intellectual disability
  • Neurological disorder
  • For healthy controls:
  • Presence of psychiatric pathologies
  • Difficulties in speaking Italian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele

Milan, Italy, 20100, Italy

Location

Related Publications (12)

  • 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: 35526293BACKGROUND
  • 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: 17079014BACKGROUND
  • 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: 11559481BACKGROUND
  • 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: 29867648BACKGROUND
  • 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: 29354082BACKGROUND
  • 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: 31923528BACKGROUND
  • 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: 24556517BACKGROUND
  • 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: 27199799BACKGROUND
  • 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: 20307557BACKGROUND
  • 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: 16008767BACKGROUND
  • 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: 33973137BACKGROUND
  • 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.

    PMID: 33137591BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersLanguage

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCommunicationBehavior

Study Officials

  • Mart Bosia, MD, PhD

    Vita-Salute San Raffaele University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.ssa

Study Record Dates

First Submitted

March 15, 2024

First Posted

April 19, 2024

Study Start

July 12, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

January 24, 2025

Record last verified: 2024-04

Locations