NCT06361407

Brief Summary

Disturbances in the sense of self and time could play an important role in the development of psychotic symptoms. Previous work has shown that patients have difficulty preparing to process information on the scale of a second, but are abnormally disturbed by slightly asynchronous information on the millisecond scale. In both cases, the anomalies could explain the patients' unusual experience of time. The hypothesis in neurotypical patients is that small delays or asynchronies asynchronies are treated as irrelevant information and ignored and ignored, whereas in patients suffering from schizophrenia they would disrupt the flow of time. This hypothesis is tested with a new visual illusion.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
18mo left

Started Jun 2024

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Jun 2024Oct 2027

First Submitted

Initial submission to the registry

April 3, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 28, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2027

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

April 3, 2024

Last Update Submit

March 24, 2026

Conditions

Keywords

sensory predictionmotion perceptionprediction error

Outcome Measures

Primary Outcomes (1)

  • Effect of a millisecond-level trajectory perturbation

    Change in the rate of illusion in case of a trajectory perturbation (compared to the rate of illusion in the absence of perturbation)

    Month 4

Secondary Outcomes (2)

  • Baseline rate of illusion

    month 4

  • Effect of a rebound (top-down, conscious influence)

    month 4

Study Arms (1)

effect of trajectory perturbation

EXPERIMENTAL

All participants will run the task consisting in 2 squares moving towards each other. On each trial they will answer whether the squares touch or do not touch. All participants are tested with all experimental conditions. The rate of 'touch' responses will be compared when there is a trajectory perturbation without rebound vs. a trajectory with perturbation with rebound vs. a trajectory without perturbation and without rebound vs. a trajectory without perturbation and with rebound.

Behavioral: Illusion task

Interventions

Illusion taskBEHAVIORAL

The task is the illusion already described in the arm description. All participants will additionally benefit from a short neuropsychological evaluation exploring attention (CPT-AX) and semantic knowledge (fNART) and a clinical evaluation exploring the sense of self (EASE).

Also known as: EASE evaluation, fNART, CPT-AX
effect of trajectory perturbation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female;
  • Age between 18 and 60 inclusive;
  • Subject having dated and signed the consent form prior to the start of any trial-related procedure (guardian or curator where applicable);
  • Member of a social security scheme or beneficiary of such a scheme.

You may not qualify if:

  • Psychoactive substance use disorders (as defined by the DSM-V) (Diagnostic and Statistical Manual-V);
  • Neurological pathology or sequelae;
  • Attention deficit hyperactivity disorder (ADHD);
  • Borderline personality disorder;
  • Disabling sensory disorders (visual acuity \<0.8);
  • Person deprived of liberty or under court protection;
  • Pregnant, parturient or breast-feeding women;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Sainte Marguerite, APHM

Marseille, France

RECRUITING

Centre Hospitalier Drôme Vivarais

Montéléger, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Anne Giersch, MD PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Giersch, MD PhD

CONTACT

Naoual MELLOUKI BENDIMRED, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The group will be masked at the stage of data analysis. It cannot be masked at the prior stages
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Individuals with schizophrenia will be tested in parallel with neurotypicals
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 11, 2024

Study Start

June 28, 2024

Primary Completion (Estimated)

October 28, 2027

Study Completion (Estimated)

October 28, 2027

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations