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

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tactile stimulation
Sponsored by
Centre Psychothérapique de Nancy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Anne GIERSCHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients

Controls

Arm Description

Patients with schizophrenia

Controls matched with patients on age, sex and education level

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Electroencephalographic measure
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.

Full Information

First Posted
February 17, 2022
Last Updated
August 2, 2023
Sponsor
Centre Psychothérapique de Nancy
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1. Study Identification

Unique Protocol Identification Number
NCT05296720
Brief Title
EEG and Behavioral Correlates of Temporal Prediction in the Tactile Modality in Schizophrenia
Acronym
SchizPredicT
Official Title
EEG and Behavioral Correlates of Temporal Prediction in the Tactile Modality in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Psychothérapique de Nancy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Other
Arm Description
Patients with schizophrenia
Arm Title
Controls
Arm Type
Other
Arm Description
Controls matched with patients on age, sex and education level
Intervention Type
Behavioral
Intervention Name(s)
Tactile stimulation
Intervention Description
Participants are asked to react as fast as possible to a tactile stimulation
Primary Outcome Measure Information:
Title
measure of movement speed
Description
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.
Time Frame
month 2
Secondary Outcome Measure Information:
Title
Electroencephalographic measure
Description
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.
Time Frame
month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne GIERSCH, MD PhD
Phone
0388116471
Ext
0033
Email
anne.giersch@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Naoual MELLOUKI BENDIM'RED, PhD
Phone
0383925267
Ext
0033
Email
unic@cpn-laxou.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne GIERSCH, MD, PhD
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anne GIERSCH
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne GIERSCH, MD PhD
Phone
0388116471
Email
anne.giersch@inserm.fr

12. IPD Sharing Statement

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

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