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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04945278
Other study ID # 29BRC20.0283
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 31, 2022
Est. completion date July 31, 2027

Study information

Verified date February 2024
Source University Hospital, Brest
Contact Nathalie LAVENNE
Phone 02 98 01 50 46
Email nathalie.lavenne-collot@chu-brest.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date July 31, 2027
Est. primary completion date July 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 that question : "who do you see more : him/her or yourself ?"
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

Locations

Country Name City State
France CHRU BREST Hôpital de Bohars Bohars

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (8)

Frith CD, Corcoran R. Exploring 'theory of mind' in people with schizophrenia. Psychol Med. 1996 May;26(3):521-30. doi: 10.1017/s0033291700035601. — View Citation

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):107-20. doi: 10.1001/jamapsychiatry.2013.269. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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