- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06361407
Sensory and Cognitive Predictions, and Their Disruptions in Schizophrenia (SensoSchiz)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the task, two squares move at constant speed in a straight line towards each other. When they collide and disappear neurotypical individuals perceive a gap between the two squares rather than contact. This unexpected effect cannot be explained by a 'cognitive' expectation, since what is consciously expected is collision and contact. It has been shown that it is sensory predictions which explain the illusion of space at the moment of contact. Indeed, a movement trajectory is accompanied by sensory predictions, which help to anticipate the position of the moving object, and of the contrast between the edges of the squares and the background. At the moment of collision, the contrast disappears and is processed as a prediction error. If subjects do not have time to correct the error, they see a gap, as if the figure-ground contrast was still there. Conversely, when a rebound effect is introduced into the task (the squares are moved in the opposite direction after the collision), the illusion diminishes, as if the rebound reinforces the (top-down) expectation of a collision.
Perturbations will be introduced during the trajectory in the illusion task with and without rebound to test this hypothesis (acceleration on a millisecond scale vs. uniform speed). Patients suffering from schizophrenia, whose prediction mechanisms are fragile, are expected to be abnormally sensitive to trajectory changes. The experimental manipulations will help to compare sensory prediction (illusion without rebound) and top-down (conscious) prediction (illusion with rebound).
The protocol will also help to specify which types of prediction (sensory or cognitive) underlie patients' sense patients' sense of self. In short, the protocol is designed to improve the pathophysiological understanding of sense-of-self disorders in schizophrenia
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne Giersch, MD PhD
- Phone Number: 0033 3 88 116471
- Email: giersch@unistra.fr
Study Contact Backup
- Name: Naoual MELLOUKI BENDIMRED, PhD
- Phone Number: 0383925267
- Email: unic@cpn-laxou.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Psychoactive substance use disorders (as defined by the DSM-V) (Diagnostic and Statistical Manual-V);
- Use of benzodiazepines, hallucinogens (in the period preceding before inclusion, for a duration equivalent to 5 half-lives of the product) or cannabis (in the 2 months preceding inclusion);
- 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;
- Subjects in a period of exclusion defined by another clinical study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: effect of trajectory perturbation
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.
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of a millisecond-level trajectory perturbation
Time Frame: Month 4
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline rate of illusion
Time Frame: month 4
|
Frequency of the illusion perception when there is no trajectory perturbation and no rebound after the collision
|
month 4
|
Effect of a rebound (top-down, conscious influence)
Time Frame: month 4
|
Change in the rate of illusion in case of a rebound (compared to the rate of illusion in the absence of rebound)
|
month 4
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Giersch, MD PhD, Institut National de la Santé Et de la Recherche Médicale, France
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-A02464-41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on Illusion task
-
Institut Robert Merle d'aubignéNot yet recruiting
-
Ruhr University of BochumCompletedCRPS | Unilateral Limb Pain of Origin Other Than CRPSGermany
-
University of ValenciaRecruitingSpinal Cord Injury | Incomplete Spinal Cord InjurySpain
-
Shanghai Mental Health CenterCompletedClinical High Risk for PsychosisChina
-
Ondokuz Mayıs UniversityCompleted
-
Istituto Auxologico ItalianoCatholic University of the Sacred Heart; Birkbeck, University of London; Heriot-Watt...Recruiting
-
Istituto Auxologico ItalianoUniversity of Turin, ItalyRecruiting
-
Gazi UniversityRecruiting
-
Centre Hospitalier Régional d'OrléansRecruiting
-
IRCCS National Neurological Institute "C. Mondino...Recruiting