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Recruiting NCT04945278

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

No phase Interventional Psychosis of Childhood Borderline Psychotic Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Double mirror device ALTER-EGO, EASE test.
Who it may be relevant to
Registry conditions: Psychosis of Childhood Borderline, Psychotic Disorder. Basic parameters: 15 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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 .

Interventions

  • Other Double mirror device ALTER-EGO
    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 th
  • Other EASE test
    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 outcome measures

  • Average of the three M1 [Time frame: Inclusion]
Secondary outcome measures (7)
  • The average of the three M2 [Time frame: Inclusion]
  • Results to tests for early prodromal symptoms assessed by SPI-A (Schizophrenia Prediction Instrument for Adults) [Time frame: Inclusion]
  • Results to tests for early prodromal symptoms assessed by PQ16 (Prodromal Questionnaire - 16) [Time frame: Inclusion]
  • Results to tests for early prodromal symptoms assessed by EASE(xamination of Anomalous Self-Experience) [Time frame: Inclusion]
  • Results to tests for later prodromal symptoms [Time frame: Inclusion]
  • Results to tests concerning the peculiarities of cognitive functioning (neuropsychological assessment) assessed by Wechsler scale [Time frame: Inclusion]
  • Results to social functioning test: [Time frame: Inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CHRU BREST Hôpital de Bohars — Bohars

Publications

  • Frith CD, Corcoran R. Exploring 'theory of mind' in people with schizophrenia. Psychol Med. 1996 May;26(3):521-30. doi: 10.1017/s0033291700035601. PMID 8733211
  • Fusar-Poli P, Borgwardt S, Bechdolf A, Addington J, Riecher-Rossler A, Schultze-Lutter F, Keshavan M, Wood S, Ruhrmann S, Seidman LJ, Valmaggia L, Cannon T, Velthorst E, De Haan L, Cornblatt B, Bonoldi I, Birchwood M, McGlashan T, Carpenter W, McGorry P, Klosterkotter J, McGuire P, Yung A. The psychosis high-risk state: a comprehensive state-of-the-art review. JAMA Psychiatry. 2013 Jan;70(1):107-2 PMID 23165428
  • Thirioux B, Wehrmann M, Langbour N, Jaafari N, Berthoz A. Identifying Oneself with the Face of Someone Else Impairs the Egocentered Visuo-spatial Mechanisms: A New Double Mirror Paradigm to Study Self-other Distinction and Interaction. Front Psychol. 2016 Aug 25;7:1283. doi: 10.3389/fpsyg.2016.01283. eCollection 2016. PMID 27610095
  • Keromnes G, Motillon T, Coulon N, Berthoz A, Du Boisgueheneuc F, Wehrmann M, Martin B, Thirioux B, Bonnot O, Ridereau R, Bellissant E, Drapier D, Levoyer D, Jaafari N, Tordjman S. Self-other recognition impairments in individuals with schizophrenia: a new experimental paradigm using a double mirror. NPJ Schizophr. 2018 Nov 28;4(1):24. doi: 10.1038/s41537-018-0065-5. PMID 30487540
  • Keromnes G, Chokron S, Celume MP, Berthoz A, Botbol M, Canitano R, Du Boisgueheneuc F, Jaafari N, Lavenne-Collot N, Martin B, Motillon T, Thirioux B, Scandurra V, Wehrmann M, Ghanizadeh A, Tordjman S. Exploring Self-Consciousness From Self- and Other-Image Recognition in the Mirror: Concepts and Evaluation. Front Psychol. 2019 May 7;10:719. doi: 10.3389/fpsyg.2019.00719. eCollection 2019. PMID 31133909
  • Uddin LQ, Davies MS, Scott AA, Zaidel E, Bookheimer SY, Iacoboni M, Dapretto M. Neural basis of self and other representation in autism: an FMRI study of self-face recognition. PLoS One. 2008;3(10):e3526. doi: 10.1371/journal.pone.0003526. Epub 2008 Oct 29. PMID 18958161
  • Ionta S, Gassert R, Blanke O. Multi-sensory and sensorimotor foundation of bodily self-consciousness - an interdisciplinary approach. Front Psychol. 2011 Dec 23;2:383. doi: 10.3389/fpsyg.2011.00383. eCollection 2011. PMID 22207860
  • Parnas J, Moller P, Kircher T, Thalbitzer J, Jansson L, Handest P, Zahavi D. EASE: Examination of Anomalous Self-Experience. Psychopathology. 2005 Sep-Oct;38(5):236-58. doi: 10.1159/000088441. Epub 2005 Sep 20. No abstract available. PMID 16179811

Identifiers

NCT: NCT04945278 · 29BRC20.0283

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗