Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06361407
Other study ID # 2023-A02464-41
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date February 28, 2028

Study information

Verified date April 2024
Source Centre Psychothérapique de Nancy
Contact Anne Giersch, MD PhD
Phone 0033 3 88 116471
Email giersch@unistra.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 68
Est. completion date February 28, 2028
Est. primary completion date April 30, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Illusion task
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).

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Centre Psychothérapique de Nancy Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline rate of illusion Frequency of the illusion perception when there is no trajectory perturbation and no rebound after the collision month 4
Secondary Effect of a rebound (top-down, conscious influence) Change in the rate of illusion in case of a rebound (compared to the rate of illusion in the absence of rebound) month 4
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A