EEG and Behavioral Correlates of Temporal Prediction in the Tactile Modality in Schizophrenia
SchizPredicT
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Apr 2023
Typical duration for not_applicable schizophrenia
1 active site
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
First Submitted
Initial submission to the registry
February 17, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedStudy Start
First participant enrolled
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
March 25, 2026
March 1, 2026
4 years
February 17, 2022
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
measure of movement speed
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.
month 2
Secondary Outcomes (1)
Electroencephalographic measure
month 2
Study Arms (2)
Patients
OTHERPatients with schizophrenia
Controls
OTHERControls matched with patients on age, sex and education level
Interventions
Participants are asked to react as fast as possible to a tactile stimulation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Psychoactive substance use disorders (as defined by DSM-V);
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anne GIERSCH
Strasbourg, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne GIERSCH, MD, PhD
Institut National de la Santé Et de la Recherche Médicale, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2022
First Posted
March 25, 2022
Study Start
April 13, 2023
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
March 25, 2026
Record last verified: 2026-03