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NCT Number: NCT04945278

Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability

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.

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Key information

Conditions

Psychosis of Childhood Borderline Mental Disorders Psychotic Disorder Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Double mirror device ALTER-EGO

Other

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 ?"

EASE test

Other

The patient will have to answer the EASE test which is a specific test to detect patient with high risk of psychosis or schizophrenia

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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

  5. 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)

  6. 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

  7. 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.

Study contacts

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

Nathalie LAVENNE

CONTACT

[email protected]

02 98 01 50 46

Nolwenn DISSAUX

CONTACT

[email protected]

06 79 38 11 16

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: ALTER-EGO

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2021
Registry last updated
Mar 19, 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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