Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability (ALTER-EGO)

February 19, 2024 updated by: University Hospital, Brest

Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability (ALTER EGO)

The main objective of this study is to establish whether there are differences in self-recognition and self/other distinction in subjects with psychological vulnerability compared to healthy volunteer controls.

Study Overview

Detailed Description

This study is based on the properties of the double mirror "Alter Ego" which is a device that appears as a double-sided mirror surrounded by light diodes whose intensity can be varied. Thanks to this variation of luminosity, this special paradigm creates morphs between two real subjects seated on both sides, resulting in different faces, each morphed to a varying extent.

In this task, participants watch a double mirror in which a picture of their own face gradually transforms into the face of an unfamiliar other (self-to-other direction) or vice versa (other-to-self direction), and indicate at which point they judge the morph to look more like the target face than the starting face.

The comparison of the thresholds obtained by different individuals makes it possible to establish whether there could be differences between subjects with psychological vulnerability and healthy controls and to explore hypothetical links between self/other distinction abilities and symptoms of psychological vulnerability .

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria for patients:

  • Aged from 15 to 25 years
  • Subject meeting the Ultra High Risk criteria at CAARMS and / or SPI-A
  • Signature of the consent (participants and parents for minors)
  • Subject affiliated to the social security scheme or benefiting from such a scheme

Inclusion criteria for healthy volunteers:

  • Aged from 15 to 25 years
  • Subject not familiar to the patient to whom it is matched
  • Signature of the consent (participants and parents for minors)
  • Subject affiliated to the social security scheme or benefiting from such a scheme

Exclusion Criteria for both patients and healthy volunteers:

  • History of epilepsy and / or migraine (due to the epileptogenic potential of light stimuli)
  • Refusal of participation of the minor even if the legal representatives want the subject to participate in the study
  • Claustrophobia
  • Wearing glasses
  • Abnormal right and left visual acuity without contact lenses
  • Distinctive signs on the face which cannot be temporarily removed
  • Subject under legal protection (curators / guardianship) or deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients

Both patients and healthy volunteers arms will undergo the double mirror test within a day.

But the patients arm will additionally respond to the EASE test.

The patient and his matched healthy volunteer will be placed on each side of the double mirror device ALTER-EGO. Both sides will be lightened alternatively or at the same time by lights, so according to the light intensity, the subject will see himself in a mirror or the other person throw a classic window. The light intensity will vary from 0 to 100% and to 100% to 0% alternatively from each side of the mirror. At each 10% variation of one side, both patient and volunteer will have to answer that question : "who do you see more : him/her or yourself ?"
The patient will have to answer the EASE test which is a specific test to detect patient with high risk of psychosis or schizophrenia
Other: Healthy volunteers
Both patients and healthy volunteers arms will undergo the double mirror test within a day.
The patient and his matched healthy volunteer will be placed on each side of the double mirror device ALTER-EGO. Both sides will be lightened alternatively or at the same time by lights, so according to the light intensity, the subject will see himself in a mirror or the other person throw a classic window. The light intensity will vary from 0 to 100% and to 100% to 0% alternatively from each side of the mirror. At each 10% variation of one side, both patient and volunteer will have to answer that question : "who do you see more : him/her or yourself ?"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average of the three M1
Time Frame: Inclusion
Average of the three M1 thresholds obtained from the "round trip" manipulation repeated three times, the M1 threshold corresponding to the level of luminosity from which a subject begins to recognize himself when his own image gradually appears (during the passage of the condition glass in mirror condition).
Inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The average of the three M2
Time Frame: Inclusion
The average of the three M2 thresholds obtained from the "round trip" manipulation repeated three times, the M2 threshold corresponding to the level of brightness from which a subject ceases to recognize himself to recognize the other (passage of the mirror mode to window mode).
Inclusion
Results to tests for early prodromal symptoms assessed by SPI-A (Schizophrenia Prediction Instrument for Adults)
Time Frame: Inclusion
• Hetero-questionnaire of SPI-A : intensity, type and frequency of symptoms : The answer "yes" to the COPER (Cognitive-Perceptive Basic Symptoms) and / or COGDIS (Cognitive Disturbances) criteria points to at risk mental state.
Inclusion
Results to tests for early prodromal symptoms assessed by PQ16 (Prodromal Questionnaire - 16)
Time Frame: Inclusion
• Self-administered questionnaire PQ16 : intensity, type and frequency of symptoms : The minimum score is 0 and maximum 16 meaning a higher state of risk.
Inclusion
Results to tests for early prodromal symptoms assessed by EASE(xamination of Anomalous Self-Experience)
Time Frame: Inclusion
• Self-experience anomalies evaluation scale : EASE, Parnas, 2003), until now not carried out as part of the routine monitoring of CEVUP (Consultation d'Evaluation de la VUlnérabilité Psychique = Psychic Vulnerability Assessment Consultation) patients : score between 0 and 57, the higher the score, the greater the risk of psychosis
Inclusion
Results to tests for later prodromal symptoms
Time Frame: Inclusion
CAARMS (Comprehensive Assessment of At-Risk Mental States) and its sub-assemblies : if the patient is at risk of psychosis, the test will classify this risk into one of the three following categories : group of trait and state risk factor, group of attenuated psychotic symptoms, group of BLIPS (Brief, Limited or Intermittent Psychotic Symptoms)
Inclusion
Results to tests concerning the peculiarities of cognitive functioning (neuropsychological assessment) assessed by Wechsler scale
Time Frame: Inclusion
• Wechsler scale : neurocognitive assessment : Total intelligence quotient (between 60 and 140 approximately) Verbal comprehension index: 50 to 160 Perceptual reasoning index: 50 to 160 Working memory index: 50 to 160 Processing speed index: 50 to 160
Inclusion
Results to social functioning test:
Time Frame: Inclusion
• Alterations in social functioning at SOFAS : Social and Occupational Functioning Assessment Scale : score theoretically between 0 and 100%. The lower the score, the worse the subject's functioning and therefore the higher the vulnerability.
Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nathalie LAVENNE, CHRU Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2022

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest University Hospital (UH). Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychotic Disorder

Clinical Trials on Double mirror device ALTER-EGO

3
Subscribe