NCT05464563

Brief Summary

This research project focuses on a fundamental element of the psychopathology of schizophrenia, that is to say, the disorders of self-awareness and on the functional alterations associated with it, that is to say, self-compassion deficit and empathy disorder. It will be a question of better understanding the neuro-functional mechanisms which underlie the lack of self-compassion and the disorder of empathy in schizophrenia, the relationship that these disorders maintain between them but also the relationship that they maintain with the general psychopathology of schizophrenia and, in particular, with the abnormalities of the self. In other words, the overall framework of this project is that of the link between the psychopathology of schizophrenia and the functional impairment associated with it. Its specific field of application is that of the link between self-awareness disorders, self-compassion deficit and empathy disorder. For this, this project proposes a methodological approach combining the recording of intrinsic and extrinsic brain activity using high-density electroencephalography (EEG).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 22, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

April 21, 2022

Last Update Submit

August 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between the temporal parameters of the EEG microstates C, D, E and F (duration, contribution, occurrence) and the inter-subject correlation index during the practice of self-compassion and the practice of empathy.

    Correlation between the temporal parameters of the EEG microstates C, D, E and F (duration, contribution, occurrence) and the inter-subject correlation index during the practice of self-compassion and the practice of empathy.

    through study completion, an average of 36 months.

Study Arms (2)

Patient group

EXPERIMENTAL

Patients have electroencephalogram records during : * a phase of rest; * a task of self-compassion * a task of empathy.

Device: Electroencephalogram

Control group

EXPERIMENTAL

Healthy volunteers have electroencephalogram records during : * a phase of rest; * a task of self-compassion * a task of empathy.

Device: Electroencephalogram

Interventions

An electroencephalogram is recorded during a task of rest then self-compassion and then empathy.

Control groupPatient group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients with a schizophrenic or schizoaffective disorder according to the DSM-5 criteria (axis 1), with no other pathology of axis 1, except addiction to tobacco
  • patients stabilized for at least 3 months for their psychotic disorders
  • patients with disease duration \> 2 years but \< 20 years
  • patients whose treatment has not been changed or modified in the previous month
  • patients on stable treatments who should not change treatment during the study (good compliance, good tolerance)
  • patients who do not benefit from a neuromodulation protocol for their symptoms (rTMS, TDCS)
  • patients who do not benefit from a cognitive remediation program
  • patients between the ages of 18 and 60
  • men and women
  • patients with normal or corrected vision
  • patients without mental impairment
  • patients without neurological impairment (epilepsy, encephalopathy, head trauma)
  • patients with a sufficient command of French
  • patients free or under protective measures
  • patients benefiting from coverage by a social security scheme or benefiting from it through a third party
  • +1 more criteria

You may not qualify if:

  • patients with an axis 1 pathology other than a schizophrenic or schizoaffective disorder (in particular, psychic trauma revealed by MINI and symptoms of PTSD (current as lifetime))
  • patients with an addiction to alcohol or other toxic substances, except tobacco
  • patients with suicidal intentionality
  • patients not stabilized for their psychotic disorders and with regard to their antipsychotic treatments
  • patients receiving antiepileptic treatment with mood-regulating, antidepressant and anxiolytic properties
  • patients receiving benzodiazepine treatment that they could not stop 72 hours before the EEG
  • patients with disease duration \< 2 years or \> 20 years
  • patients with an IQ \< 70
  • patients benefiting from a neuromodulation protocol (rTMS, TDCS)
  • patients benefiting from a cognitive remediation program
  • patients with a PANSS \> or = 5 for items G8 (hostility) and P7 (non-cooperation)
  • patients aged \< 18 years or \> 60 years
  • patients with mental impairment
  • patients with neurological impairment (epilepsy, encephalopathy, head trauma)
  • patients with documented neurological pathology or medical condition that may explain the psychotic manifestations
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Henri Laborit

Poitiers, 86000, France

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

July 19, 2022

Study Start

March 22, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations