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NCT Number: NCT05296720

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tactile stimulation

Behavioral

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

Primary outcomes

  1. measure of movement speed

    Time frame: month 2

    Motor anticipation: The participant moves his or her finger until a tactile stimulation is delivered, and the finger trajectory is recorded by means of a LED on the finger and a camera. The analysis of the trajectory allows for a measure of movement speed, acceleration and deceleration. The anticipation of the need to stop the movement is typically accompanied by a slowing down of the trajectory. The slowing down of the trajectory is used as a proxy for the anticipation of the tactile stimulation. We will measure at what time before the tactile stimulation the deceleration starts.

Secondary outcomes

  1. Electroencephalographic measure

    Time frame: month 2

    The Electroencephalographic signal will be measured throughout the task in order to evaluate neurobiological correlates of the expectation. Expectation is associated with a CNV (Contingent Negative Variation), and this potential will be compared across the different experimental conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne GIERSCH, MD PhD

CONTACT

[email protected]

0388116471 ext. 0033

Naoual MELLOUKI BENDIM'RED, PhD

CONTACT

[email protected]

0383925267 ext. 0033

Sponsors and collaborators

Lead sponsor

Centre Psychothérapique de Nancy

Other

Registry information

Acronym: SchizPredicT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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