NCT05296720

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
17mo left

Started Apr 2023

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress69%
Apr 2023Oct 2027

First Submitted

Initial submission to the registry

February 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

February 17, 2022

Last Update Submit

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

OTHER

Patients with schizophrenia

Behavioral: Tactile stimulation

Controls

OTHER

Controls matched with patients on age, sex and education level

Behavioral: Tactile stimulation

Interventions

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

ControlsPatients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Anne GIERSCH, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne GIERSCH, MD PhD

CONTACT

Naoual MELLOUKI BENDIM'RED, PhD

CONTACT

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

Locations