Schizophrenia Clinical Trial
— IMPACTRCSOfficial title:
Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia
Verified date | February 2024 |
Source | Hôpital le Vinatier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Neurocognitive deficits are frequent with people suffering from schizophrenia. Unlike positive symptoms, cognitive deficits are not reduced with antipsychotic medication. They can be very disabling, especially for social and professional rehabilitation. Cognitive deficits can concern primary processes such as attention or more integrative processes. Social cognition is also massively altered. As a consequence, decision making is often altered with the presence of the 'jumping to conclusion' (JTC) phenomenon. People that jump to conclusion are making decisions without having the necessary information to be sure of their judgment. In addition, people suffering from schizophrenia also present differences in cerebral activity. For instance, the P300 involved in executive processes appears later and with a smaller amplitude. Many cognitive remediation programs have been created to overcome these deficits. Their efficiency has been proved. However, their effects on cerebral activity have not been studied extensively in literature, especially concerning decision making changes. The present project will use a cognitive remediation program centered on social decision making to test its efficiency on JTC and the potential changes in cerebral activity it can induce. This program, inspired by the SCIT (Social Cognition and Interaction Technique) will be based on 10 sessions (1 each week). Participants will be tested before and after remediation/control group with 3 experimental tasks. Cerebral activity will be measured with an EEG cap. They will also undergo a neuropsychological evaluation and a symptomatology evaluation.
Status | Terminated |
Enrollment | 78 |
Est. completion date | June 17, 2023 |
Est. primary completion date | June 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - People suffering from schizophrenia given the DSM-5 - People aged from 18 to 45 years old - French mother tongue - Medicated with Aripiprazole - Medication unchanged in the last month - Stable symptomatology - People consenting to the research. Exclusion Criteria: - Recent addiction (tabacco excluded) - Neurologic disorders (vascular disorders, neurodegenerative disorders, infections…) - Somatic medication having cerebral impact (such as corticoids) - Pregnant women, guardianship people. |
Country | Name | City | State |
---|---|---|---|
France | centre de réhabilitation - Hôpital le Vinatier | Lyon | Rhône |
Lead Sponsor | Collaborator |
---|---|
Hôpital le Vinatier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Jumping to the conclusion | The primary outcome will be modification before and after intervention of the correct response percentage. It is obtained by measuring the amplitude of the waves P300 and N200 of the electroencephalogram. | 12 weeks | |
Secondary | Warwick-Edinburg mental well-being (WEMWBS) | The outcome measure of mental well-being will be the score of scale modification before and after intervention. It is a questionnaire that includes 14 items. | 12 weeks | |
Secondary | The positive and the negative symptoms (PANNS) | The measure of the cognitive fonctioning will be the modification before and after intervention of the score obtained at the proposed neuropsychological evaluation ( excecutive, attentional and social) | 12 weeks |
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