- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04945278
Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability (ALTER-EGO)
Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability (ALTER EGO)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nathalie LAVENNE
- Phone Number: 02 98 01 50 46
- Email: nathalie.lavenne-collot@chu-brest.fr
Study Contact Backup
- Name: Nolwenn DISSAUX
- Phone Number: 06 79 38 11 16
- Email: nolwenn.dissaux@chu-brest.fr
Study Locations
-
-
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Bohars, France, 29280
- Recruiting
- CHRU BREST Hôpital de Bohars
-
Contact:
- LAVENNE-COLLOT
- Phone Number: 00332 98 01 50 46
- Email: nathalie.lavenne-collot@chu-brest.fr
-
Contact:
- DISSAUX
- Phone Number: 00336 79 38 11 16
- Email: nolwenn.dissaux@chu-brest.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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
Sponsor
Investigators
- Principal Investigator: Nathalie LAVENNE, CHRU Brest
Publications and helpful links
General Publications
- 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.
- Frith CD, Corcoran R. Exploring 'theory of mind' in people with schizophrenia. Psychol Med. 1996 May;26(3):521-30. doi: 10.1017/s0033291700035601.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC20.0283
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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