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

Primary Purpose

Psychosis of Childhood Borderline, Psychotic Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Double mirror device ALTER-EGO
EASE test
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychosis of Childhood Borderline focused on measuring Mental Vulnerability, Self-recognition, Psychosis High-Risk State, Self-other Distinction, Double Mirror Paradigm, Schizophrenia

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHRU BREST Hôpital de BoharsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients

Healthy volunteers

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.
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
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)
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
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.

Full Information

First Posted
April 22, 2021
Last Updated
May 31, 2022
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04945278
Brief Title
Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability
Acronym
ALTER-EGO
Official Title
Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability (ALTER EGO)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis of Childhood Borderline, Psychotic Disorder
Keywords
Mental Vulnerability, Self-recognition, Psychosis High-Risk State, Self-other Distinction, Double Mirror Paradigm, Schizophrenia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective interventional case / control trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Other
Arm Description
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.
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Both patients and healthy volunteers arms will undergo the double mirror test within a day.
Intervention Type
Other
Intervention Name(s)
Double mirror device ALTER-EGO
Intervention Description
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 ?"
Intervention Type
Other
Intervention Name(s)
EASE test
Intervention Description
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 Measure Information:
Title
Average of the three M1
Description
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).
Time Frame
Inclusion
Secondary Outcome Measure Information:
Title
The average of the three M2
Description
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).
Time Frame
Inclusion
Title
Results to tests for early prodromal symptoms assessed by SPI-A (Schizophrenia Prediction Instrument for Adults)
Description
• 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.
Time Frame
Inclusion
Title
Results to tests for early prodromal symptoms assessed by PQ16 (Prodromal Questionnaire - 16)
Description
• Self-administered questionnaire PQ16 : intensity, type and frequency of symptoms : The minimum score is 0 and maximum 16 meaning a higher state of risk.
Time Frame
Inclusion
Title
Results to tests for early prodromal symptoms assessed by EASE(xamination of Anomalous Self-Experience)
Description
• 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
Time Frame
Inclusion
Title
Results to tests for later prodromal symptoms
Description
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)
Time Frame
Inclusion
Title
Results to tests concerning the peculiarities of cognitive functioning (neuropsychological assessment) assessed by Wechsler scale
Description
• 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
Time Frame
Inclusion
Title
Results to social functioning test:
Description
• 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.
Time Frame
Inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie LAVENNE
Phone
02 98 01 50 46
Email
nathalie.lavenne-collot@chu-brest.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nolwenn DISSAUX
Phone
06 79 38 11 16
Email
nolwenn.dissaux@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie LAVENNE
Organizational Affiliation
CHRU BREST
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU BREST Hôpital de Bohars
City
Bohars
ZIP/Postal Code
29280
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LAVENNE-COLLOT
Phone
00332 98 01 50 46
Email
nathalie.lavenne-collot@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
DISSAUX
Phone
00336 79 38 11 16
Email
nolwenn.dissaux@chu-brest.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
8733211
Citation
Frith CD, Corcoran R. Exploring 'theory of mind' in people with schizophrenia. Psychol Med. 1996 May;26(3):521-30. doi: 10.1017/s0033291700035601.
Results Reference
background
PubMed Identifier
23165428
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.
Results Reference
background
PubMed Identifier
27610095
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.
Results Reference
background
PubMed Identifier
30487540
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.
Results Reference
background
PubMed Identifier
31133909
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.
Results Reference
background
PubMed Identifier
18958161
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.
Results Reference
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PubMed Identifier
22207860
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.
Results Reference
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PubMed Identifier
16179811
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.
Results Reference
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Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability

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