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Trial record 5 of 3313 for:    schizophrenia

Perception of Facial Emotions in Schizophrenia and 22q11 Deletion Syndrome (FaSchi22)

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ClinicalTrials.gov Identifier: NCT02634671
Recruitment Status : Completed
First Posted : December 18, 2015
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

Brief Summary:

Background:

The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in schizophrenia and the 22q11.2 deletion syndrome, and thus, reveal a distinction between the two disorders. Indeed, despite the clinical overlap between the two syndromes, some of the symptoms appear to be specific to only one of them. In particular, the disturbance of visual functions is specifically observed in the 22q11.2DS. Hence, the difficulties in facial emotion recognition in schizophrenia and in the 22q11.DS are likely accounted by different cognitive impairments. Investigating which mechanisms are disturbed would allow a specialized support for patients.

Our main hypothesis is that the deficit in facial emotion recognition is more related to visual impairments in the 22q11.2DS than in schizophrenia. This hypothesis will be tested in two groups of patients (22q11.2DS and schizophrenic patients) and a control group (healthy subjects) using an experimental paradigm based on electroencephalography (EEG).

A second aim of this study is to determine whether the severity of the two disorders' symptoms is correlated with the cerebral response to facial expressions. To answer this question, a set of clinical and neuropsychological tests will be conducted for each patient.


Condition or disease Intervention/treatment Phase
Schizophrenia Other: schizophrenia Other: the 22q11 deletion syndrome Other: control group Not Applicable

Detailed Description:

Methods:

This study will be conducted using visual steady-state visual evoked potentials (SSVEPs). Visual SSVEPs are periodic neural electrophysiological activities that arise in response to fast periodic visual stimulation (FPVS). They will be recorded in response to the periodic presentation of faces, according to an oddball paradigm. While pictures of faces will appear at a 6 Hz rate, only 1 out of 5 will display an emotion, corresponding to a 1.2 Hz oddball frequency. Different emotions will be tested (happiness, sadness, anger, fear and disgust), displayed with different intensities (20%, 60%, 100%). SSVEPs at 6 Hz will reflect general visual mechanisms (in response to a mixture of low-level (i.e., contrast coding) and high-level (i.e., face detection) processes). Importantly, SSVEPs at 1.2 Hz will index the visual mechanisms specifically involved in facial expression perception and their sensitivity to emotion intensity. Both measures will help determine the underlying brain topographies.

Alongside, clinical and neuropsychological tests will be conducted. While the clinical tests will evaluate the severity of the symptoms, the neuropsychological tests will assess different features such as attention, memory, verbal and visuo-spatial abilities. The patients' scores will be linked with their cerebral activity in response to facial expressions.

Outcomes:

To better understand the impairment of facial emotion recognition in schizophrenia and 22q11.2DS and to improve its care.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Facial Expression Perception by Intensity in Schizophrenia and 22q11.2 Deletion Syndrome: Neural Electrophysiological Evidence by Means of Fast Periodic Visual Stimulation
Study Start Date : November 2015
Actual Primary Completion Date : October 20, 2017
Actual Study Completion Date : December 30, 2017


Arm Intervention/treatment
22Q11
24 patients with 22Q11DS to determine whether the severity of the two disorders' symptoms is correlated with the cerebral response to facial expressions. To answer this question, a set of clinical and neuropsychological tests will be conducted for each patient.
Other: schizophrenia
The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in schizophrenia with a control group using an experimental paradigm based on electroencephalography (EEG)

Other: control group
The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in the schizophrenia and 22q11.2 deletion syndrome with a control group using an experimental paradigm based on electroencephalography (EEG)

SCHIZOPHRENIA
24 patients with schizophrenia to determine whether the severity of the two disorders' symptoms is correlated with the cerebral response to facial expressions. To answer this question, a set of clinical and neuropsychological tests will be conducted for each patient.
Other: the 22q11 deletion syndrome
The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in the 22q11.2 deletion syndrome with a control group using an experimental paradigm based on electroencephalography (EEG)

Other: control group
The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in the schizophrenia and 22q11.2 deletion syndrome with a control group using an experimental paradigm based on electroencephalography (EEG)




Primary Outcome Measures :
  1. Steady-state visual evoked potentials (SSVEP) recorded during fast periodic visual stimulation (FPVS). [ Time Frame: SSVEPs will be recorded during 20 sequences of emotional faces pictures. As each sequence lasts 80s, the EEG recording will be approximately 30-minutes-long. ]
    SSVEPs arise in response to the periodic presentation of emotional faces. They are analyzed in the frequency domain. Two types of responses are expected: the general visual response (6 Hz and its harmonics) and the expression-specific response (1.2 Hz and its harmonics). Both responses will be compared across the different groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 15-50 years old
  • No psychiatric conditions or comorbidity
  • Agreement from parents if participant is underage
  • Patients with schizophrenia: diagnosis assessed with DSM5 criteria
  • Patients with 22q11.2 DS: diagnosis assessed by genetic tests (CGH- array or FISH)
  • No mental delay (IQ>70 according to the fNART)
  • No modification of psychotropic treatment during the month before inclusion

Exclusion Criteria:

  • Involvement in a current program of social cognition remediation
  • Pregnancy
  • Substance use disorder (criteria of DSM-5), except for caffeine and tobacco
  • Neurologic disorders (vascular, infectious or neurodegenerative)
  • Uncorrected visual deficit
  • Guardianship
  • Medical drugs with cerebral or psychological effect (e.g, corticosteroids)
  • Resistance to antipsychotics
  • Electroconvulsive therapy in the previous two months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634671


Sponsors and Collaborators
Hôpital le Vinatier
Investigators
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Principal Investigator: DEMILY CAROLINE, PH Centre régional de dépistage et de prises en charge des troubles psychiatriques d'origine génétique Pôle Ouest LE VINATIER HOSPITAL

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Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02634671     History of Changes
Other Study ID Numbers: 2015-A01247- 42
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Keywords provided by Hôpital le Vinatier:
schizophrenia
Facial emotions
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders