EEG and Behavioral Correlates of Temporal Prediction in the Tactile Modality in Schizophrenia

NCT ID: NCT05296720

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2025-10-31

Brief Summary

Patients with schizophrenia have disturbances in their sense of self, particularly their bodily self. Disorders of the sense of self are central to schizophrenia and are of interest because they are thought to be present prior to the development of the disorder, when only a few attenuated symptoms signal a risk of developing psychosis. Finding markers related to the sense of self would make it possible to predict which subjects, among those with minimal psychotic symptoms, will develop psychosis, and thus to better adapt management. Disturbances in the experience of the passage of time that accompany disturbances in the sense of self have been described particularly in subjects at risk of developing psychosis, and would predict the onset of the pathology. However, as with alterations in the sense of self, it can be difficult to get patients to describe their disturbances in the experience of time, and objective measures are required to facilitate detection of these disturbances. In the present protocol an objective measure of temporal perception mechanisms will be tested in relation to the sense of self.

The tests used in the protocol assess subjects' abilities to benefit from the passage of time and to use these abilities to predict and prepare for the occurrence of an event. The investigators have previously shown that patients with impaired bodily sense of self do not benefit from the passage of time to prepare themselves to process information in the future. The present protocol is aimed at developing a measure more sensitive to the patients' disorders by adding tactile measures.

Detailed Description

Patients with schizophrenia have disturbances in their sense of self, particularly their bodily self. Disorders of the sense of self are central to schizophrenia and are of interest because they are thought to be present prior to the development of the disorder, when only a few attenuated symptoms signal a risk of developing psychosis. Finding markers related to the sense of self would make it possible to predict which subjects, among those with minimal psychotic symptoms, will develop psychosis, and thus to better adapt management. Disturbances in the experience of the passage of time that accompany disturbances in the sense of self have been described particularly in subjects at risk of developing psychosis, and would predict the onset of the pathology. However, as with alterations in the sense of self, it can be difficult to get patients to describe their disturbances in the experience of time, and objective measures are required to facilitate detection of these disturbances. In the present protocol an objective measure of temporal perception mechanisms will be tested in relation to the sense of self.

The tests used in the protocol assess subjects' abilities to benefit from the passage of time and to use these abilities to predict and prepare for the occurrence of an event. The investigators have previously shown that patients with impaired bodily sense of self do not benefit from the passage of time to prepare themselves to process information in the future. The present protocol is aimed at developing a measure more sensitive to the patients' disorders by adding tactile measures.

Conditions

Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Patients

Patients with schizophrenia

Group Type: OTHER

Tactile stimulation

Intervention Type: BEHAVIORAL

Participants are asked to react as fast as possible to a tactile stimulation

Controls

Controls matched with patients on age, sex and education level

Group Type: OTHER

Tactile stimulation

Intervention Type: BEHAVIORAL

Participants are asked to react as fast as possible to a tactile stimulation

Interventions

Tactile stimulation

Participants are asked to react as fast as possible to a tactile stimulation

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male or Female;
• Age between 18 and 60 years inclusive;
• Subject who has dated and signed the consent form (guardian or custodian prior to the commencement of any trial-related procedures if applicable);
• Enrolled in a social security plan or beneficiary of such a plan.

Exclusion Criteria

• Psychoactive substance use disorders (as defined by DSM-V);
• Use of benzodiazepines (in the period prior to inclusion, for a duration equivalent to 5 half-lives of the product), cannabis (in the 2 months prior to inclusion; use of cannabis (THC) will be verified with a urine dipstick) or hallucinogenic substances (in the period prior to inclusion, for a duration equivalent to 5 half-lives of the product);
• Neurological pathology or sequelae;
• Attention deficit hyperactivity disorder (ADHD);
• A borderline personality disorder;
• Disabling sensory disorders;
• Person deprived of liberty or under court protection;
• Pregnant, parturient or nursing woman;
• Subject in a period of exclusion as defined by another clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Psychothérapique de Nancy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne GIERSCH, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Anne GIERSCH

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Anne GIERSCH, MD PhD

Role: CONTACT

anne.giersch@inserm.fr

0388116471 ext. 0033

Naoual MELLOUKI BENDIM'RED, PhD

Role: CONTACT

unic@cpn-laxou.com

0383925267 ext. 0033

Facility Contacts

Anne GIERSCH, MD PhD

Role: primary

anne.giersch@inserm.fr

0388116471

Other Identifiers

021-A02434-37

Identifier Type: -

Identifier Source: org_study_id