NCT06886945

Brief Summary

Schizophrenia (SCZ) is a severe neuropsychiatric disorder characterized by cognitive decline, social withdrawal, and positive symptoms such as hallucinations and delusions. Research suggests that SCZ and schizotypy exist along a continuum, with shared structural and behavioral abnormalities, the latter of which encompass the sensory and perceptual domain, often in the form of altered multisensory integration, as seen in tasks like the Sound-Induced Flash Illusion (SIFI). Individuals with schizotypal traits or SCZ show enlarged temporal binding windows (TBW) of cross-modal integration, affecting perceptual accuracy and multisensory judgments. However, whether these deficits stem from overactive top-down modulation or weakened bottom-up sensory precision remains unclear. The current study seeks to address these questions, by asking participants (healthy individuals screened as for their schizotypal traits, and patients suffering from SCZ) to complete a modified version of the SIFI, as well as an audiovisual temporal order judgment (TOJ) task. Cross-modal performance will be assessed via signal detection theory (SDT) metrics and psychometric modeling to estimate individual TBWs, thereby assaying audiovisual processing abilities along the schizotypal continuum

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

April 9, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
7 months 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

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

March 14, 2025

Last Update Submit

March 14, 2025

Conditions

Keywords

SchizophreniaAudio-Visual IntegrationTemporal Binding WindowsSignal Detection TheorySchizotypal Personality

Outcome Measures

Primary Outcomes (1)

  • Temporal Binding Window (TBW) length

    The temporal binding window (TBW) is a psychophysical construct that reflects an observer's tolerance for temporal asynchrony-a "window" of time within which multisensory stimuli are likely to be perceptually bound or integrated. As such, it serves as a proxy for cross-modal performance. In both tasks, individual TBWs will be estimated for each participant by fitting gaussian and sigmoidal logistic functions to error rates (i.e., inverse accuracy) and perceptual sensitivity metrics (i.e., d', as computed combining hits and flase alarms according to signal detection theory), respectively, across the asynchrony space (e.g., at each SOA). The width (e.g., standard deviation) of the gaussian function and the inflection point (e.g., midpoint) of the sigmoidal curve will be then derived on a participant-by-participant basis, serving as behavioral indices of TBW span (in milliseconds) for further statistical analyses and comparison between groups.

    Right after tasks completion

Study Arms (3)

SCZ

Patients diagnosed with schizophrenia spectrum disorders

Other: Audio-Visual Perceptual Tasks

LST

Healthy individuals displaying low schizotypal traits

Other: Audio-Visual Perceptual Tasks

HST

Healthy individuals displaying high schizotypal traits

Other: Audio-Visual Perceptual Tasks

Interventions

Around 75 participants will be recruited for this study (25 per each group), and asked to perform two distinct audiovisual tasks (run via Matlab-based automated routines, and presented using a CRT monitor and a pair of loudspeakers) : 1. TOJ task, in which a white flashing dot, and a basic auditory stimulus, will be presented in close temporal proximity at several stimulus onset asynchronies (SOAs, from 30 to 540 ms in steps of 30 ms), with participants asked to report ( after each trial), which stimulus occurred first (task duration estimate: 25 minutes, 30 trials per each SOA) 2. A modified version of the SIFI (mSIFI), in which the presentation of paired (and temporally close) auditory stimuli will be coupled with the occurrence of either 1 or 2 flashing dots, at several different SOAs (from 30 to 250 ms in steps of 10 ms), with participants asked to report (after each trial), whether they saw 1 vs 2 flashes (task duration estimate: 25 minutes, 30 trials per each SOA)

HSTLSTSCZ

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy participants assigned either to the low (LST) or high (HST) schizotypal group will be recruited from the general population, after being screened for their schizotypal traits via the Schizotypal Personality Questionnaire (SPQ, Raine, 1991). Individuals with SPQ scores falling within the first and last quintile of the overall SPQ scores distribution will then be recruited and assigned, respectively, to the LST and HST groups. SCZ patients will be recruited via the Psychiatric Unit of IRCCS Centro San Giovanni di Dio Fatebenefratelli

You may qualify if:

  • Normal hearing
  • Normal or corrected-to-normal vision
  • Clinical diagnosis of schizophrenia spectrum disorder (according to DSM-5)
  • IQ \> 70

You may not qualify if:

  • Anamnesis or evidence of any central nervous system alteration
  • Current major physical illness
  • Drug dependency/abuse over the last 6 months
  • Unstable pharmacological therapy
  • Comorbidities with other major psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, BS, 24125, Italy

RECRUITING

MeSH Terms

Conditions

SchizophreniaSchizotypal Personality Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPersonality Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 20, 2025

Study Start

April 9, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03

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