ClinicalTrials.gg
RecruitingNCT06886945Updated Mar 20, 2025

An Integrated Neurophysiological Approach Toward the Early Detection of Psychiatric Disorders

An observational study in Schizophrenia Disorders, sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.

Sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 7 months later.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
75
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 65 studies in Schizophrenia with a site in Italy — 7 open to participants now, 9 under way, none of them phase 3. Schizophrenia · Italy.

Planned enrollment
16th of 18
75 · median 273
Started
2024
with 3 others
Observational
18 of 65
3 open now
Registered
61st of 65
by date

Among the 65 studies in Schizophrenia with a site in Italy, this one is the 16th largest by planned enrollment of the 18 observational ones that give a count, is one of 4 that started in 2024, is one of 18 observational ones, and was the 61st registered.

Schizophrenia

3,565 studies on the registry are indexed under Schizophrenia; 492 are open to participants now.

Browse Schizophrenia studies →

Open to participants now

7 of the 65 studies in Schizophrenia with a site in Italy are open now. Recruiting first, the newest first:

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All 7 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.

This study: 18 Years to 50 Years · all sexes · healthy volunteers too.

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02

Study 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

Read the detailed description

Schizophrenia (SCZ) is among the most debilitating syndromes within the neuropsychiatric domain, with patients suffering from this condition displaying a rich nosographic characterization. Besides, anhedonia, social withdrawal, and a progressive cognitive decline, positive manifestations such as delusions and hallucinations are perhaps the hallmark symptomatological features underlying this disorder. Notably, prodromal stages that entail subclinical cognitive and/or psychotic symptoms have often been shown to anticipate SCZ onset, corroborating a dimensional approach toward the understanding of such psychiatric disorder. Indeed, it has been proposed that schizotypal traits exist within the general population and that schizotypy and SCZ may correspond to quantitative poles within the same continuum, with the former (i.e., individuals characterized with high schizotypal traits, HST) including subjects displaying many SCZ-related subthreshold clinical signs, and thus, more likely to develop the latter. However, no reliable biomarker to early detect such psychosis-prone individuals has been so far, leaving clinicians without pre-emptive policies toward risk mitigation.

It should be nonetheless highlighted that both demeaned microstructural and white matter integrity have been reported in schizotypy and SCZ alike, the magnitude of which predicting the severity of positive symptoms at the individual level. Given the pivotal role these neuroanatomical features play in relaying electrical signals across the brain, it is not surprising that SCZ patients, as well as HST individuals, oftentimes exhibit aberrant oscillatory dynamics within the low-frequency ranges, such as in the alpha band (7-13 Hz). These brain oscillations are the dominant rhythm in both the resting and active brain. As such, they have been found to subserve many functions closely tied to sensory processing. Among multifold operational features these rhythms appear to be endowed with, their occipital cycling speed (i.e., individual alpha frequency peak, also known as IAF) has been recently associated with the efficiency by which sensory information is integrated or segregated, according to the task at hand . In agreement with the discrete sampling hypothesis of perception, the faster (or slower) these rhythms oscillate, the higher (or lower) the observers' visual sampling rate and their perceptual or cognitive accuracy.

Of note, this electrocortical index bears trait-like features that have been shown to parametrize perceptual performance, especially in multisensory contexts.

For instance, the propensity to report an illusory percept in audiovisual tasks such as the Sound-Induced Flash Illusion (SIFI) was found to negatively correlate with the IAF as recorded from occipital loci: the slower the IAF, the greater the number of illusory percepts and vice-versa. These results align with pieces of research showing a critical contribution of alpha oscillatory speed when individuals are asked to perform cross-modal simultaneity judgments and visuo-tactile tasks as well. Intriguingly, evidence for a tie between the IAF and multisensory temporal binding windows (TBW) has been further reinvigorated by data showing slower IAFs in patients suffering from schizophrenia or displaying schizotypal traits. Namely, those clinical and subclinical populations performing poorly at the SIFI, and, more broadly, multisensory paradigms, due to enlarged TBWs.

As for the neurocomputational mechanics subsiding this intricate pattern of alterations, it remains a matter of debate whether they might be driven either by an over-exploitation of auditory-relayed priors, or poor bottom-up sensory processing. Indeed, although alterations in sensory integration/segregation are a core hallmark of SCZ, it is not entirely clear whether such behavioral and cognitive impairments might be due to defective sensory processing (i.e. poor sensory input due to reduced feedforward connectivity), or aberrant perceptual bias mechanisms (i.e. disproportionately high top-down signaling), and to which extent they may be present at prodromal stages of the disease. To this aim, we will therefore investigate the performance of SCZ patients, and individuals displaying either high (HST) or low (LST) schizotypal traits, in a series of tasks relying on multisensory interaction. We will do so by implementing signal detection theory (SDT) matched with logistic fitting, to clarify at a finer-grained level whether alterations in multisensory processes can be accounted for by deficits at the level of sensory input (d'), top-down control (c), or both.

03

Conditions studied

  • Schizophrenia Disorders

Keywords

  • Schizophrenia
  • Audio-Visual Integration
  • Temporal Binding Windows
  • Signal Detection Theory
  • Schizotypal Personality
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability 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

Eligibility criteria

Inclusion Criteria (all participants):

  • Normal hearing
  • Normal or corrected-to-normal vision

Inclusion Criteria (patients):

  • Clinical diagnosis of schizophrenia spectrum disorder (according to )
  • IQ > 70

Exclusion Criteria (all participants):

  • Anamnesis or evidence of any central nervous system alteration

Exclusion Criteria (patients)

  • Current major physical illness
  • Drug dependency/abuse over the last 6 months
  • Unstable pharmacological therapy
  • Comorbidities with other major psychiatric disorders
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherAudio-Visual Perceptual Tasks

    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)

06

What researchers measure

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.

    Time frame: Right after tasks completion

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Oct 2025, 18 months after the start.

Of 114 non-industry observational studies under Schizophrenia, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 114. This study's planned 18 months is below that.

Counting every sponsor, half of 136 studies reached it within 47 months; a quarter within 27 and three quarters within 102.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2025
First posted
Mar 20, 2025
StartActual
Apr 9, 2024
Primary completionEst.
Oct 2025
CompletionEst.
Oct 2025
Last update
Mar 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06886945
Lead sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Responsible party
Sponsor
First posted
Mar 20, 2025
Start date
Apr 9, 2024
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Mar 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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