Status:
NOT_YET_RECRUITING
Intermittent Theta Burst Stimulation of the Precuneus
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborating Sponsors:
Euraxi Pharma
Conditions:
Schizophrenia
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The purpose of the study is to compare the effectiveness of stimulation of the left precuneus by intermittent Theta Burst Stimulation to placebo stimulation on the severity of schizophrenia symptoms.
Detailed Description
This is an interventional, prospective, randomized, double-blind, multicenter study, comparing iTBS treatment (experimental group) of the precuneus to placebo stimulation (control group) of patients s...
Eligibility Criteria
Inclusion
- Right-handed patient aged 18 to 40 years inclusive;
- Patient presenting schizophrenia as defined in the Diagnostic and Statistical Manual-5;
- Patient under antipsychotic treatment in accordance with the recommendations of the High Authority of Health, at a stable dosage and without modification of psychotherapeutic treatment for at least 4 weeks;
- Patient on mono or dual antipsychotic therapy.
- Patient presenting residual symptoms, i.e. absence of remission defined by the criteria of the "Remission criteria of the Schizophrenia Working Group Consensus";
- Patient having been exposed to at least one type of trauma in childhood and having a score higher than the threshold values of the childhood trauma questionnaire: emotional neglect, physical abuse, emotional abuse, physical neglect, sexual abuse;
- Patient having signed an informed consent form to participate in the study.
Exclusion
- Patient with a contraindication to magnetic resonance imaging or intermittent Theta Burst Stimulation (presence of a metallic body, pacemaker, implantable defibrillator or other implantable metallic device, epilepsy, stroke or recent head trauma);
- Patient who is not French-speaking or cannot read and write;
- Patient under guardianship;
- Patient in forced care (psychiatric care upon decision of the State representative and psychiatric care at the request of a third party);
- Pregnant woman or likely to be pregnant (of childbearing age) without effective contraception or breastfeeding;
- Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
- Patient who is not a beneficiary of a social security system.
- Patient who, according to the assessment of the investigator, risks not being compliant or diligent in the study procedures.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06142422
Start Date
April 1 2025
End Date
June 1 2026
Last Update
March 27 2025
Active Locations (1)
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1
Clinique Rech
Montpellier, France, 34093