NCT04945278

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
May 2022Jul 2027

First Submitted

Initial submission to the registry

April 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

5.2 years

First QC Date

April 22, 2021

Last Update Submit

March 18, 2026

Conditions

Keywords

Mental VulnerabilitySelf-recognitionPsychosis High-Risk StateSelf-other DistinctionDouble Mirror ParadigmSchizophrenia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • The average of the three M2

    Inclusion

  • Results to tests for early prodromal symptoms assessed by SPI-A (Schizophrenia Prediction Instrument for Adults)

    Inclusion

  • Results to tests for early prodromal symptoms assessed by PQ16 (Prodromal Questionnaire - 16)

    Inclusion

  • Results to tests for early prodromal symptoms assessed by EASE(xamination of Anomalous Self-Experience)

    Inclusion

  • Results to tests for later prodromal symptoms

    Inclusion

  • +2 more secondary outcomes

Study Arms (2)

Patients

OTHER

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.

Other: Double mirror device ALTER-EGOOther: EASE test

Healthy volunteers

OTHER

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

Other: Double mirror device ALTER-EGO

Interventions

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

Patients

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 ?"

Healthy volunteersPatients

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU BREST Hôpital de Bohars

Bohars, 29280, France

RECRUITING

Related 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.

    PMID: 8733211BACKGROUND
  • 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.

    PMID: 23165428BACKGROUND
  • 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: 27610095BACKGROUND
  • 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: 30487540BACKGROUND
  • 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: 31133909BACKGROUND
  • 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: 18958161BACKGROUND
  • 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: 22207860BACKGROUND
  • 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: 16179811BACKGROUND

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Nathalie LAVENNE

    CHRU BREST

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Prospective interventional case / control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

June 30, 2021

Study Start

May 31, 2022

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
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.

Locations