Intermittent Theta Burst Stimulation of the Precuneus

NCT ID: NCT06142422

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-06-30

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 suffering from resistant schizophrenia and having been exposed to childhood trauma.

The study population will be patients aged 18 to 40 years old exposed to childhood trauma, presenting with schizophrenia resistant to antipsychotic treatments.

This study will be implemented in 4 investigative centers. Each patient will participate for a period of 3 months.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

experimental group with intermittent Theta Burst Stimulation

The procedure under study is the use of a stimulation device to perform intermittent Theta Burst Stimulation treatment on the precuneus to treat resistant schizophrenia. Targeting requires a neuronavigation device.

Group Type: EXPERIMENTAL

stimulation device

Intervention Type: PROCEDURE

The procedure under study is the use of a stimulation device to perform treatment on the precuneus to treat resistant schizophrenia in patients exposed to childhood trauma.

The target is the left precuneus, which is defined by neuronavigation.

control group with placebo stimulation

In the control group, stimulation is simulated using a "Sham" or placebo coil. The stimulation device is the same as for the experimental group, only the coil differs.

Group Type: PLACEBO_COMPARATOR

stimulation device

Intervention Type: PROCEDURE

The procedure under study is the use of a stimulation device to perform treatment on the precuneus to treat resistant schizophrenia in patients exposed to childhood trauma.

The target is the left precuneus, which is defined by neuronavigation.

Interventions

stimulation device

The procedure under study is the use of a stimulation device to perform treatment on the precuneus to treat resistant schizophrenia in patients exposed to childhood trauma.

The target is the left precuneus, which is defined by neuronavigation.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Rech

Montpellier, , France

Countries

France

Central Contacts

Aïda CANCEL, MD

Role: CONTACT

aida.cancel@hotmail.fr

625488144 ext. +33

Facility Contacts

Aïda CANCEL, MD

Role: primary

aida.cancel@hotmail.fr

625488144 ext. +33

Other Identifiers

2023-A01006-39

Identifier Type: -

Identifier Source: org_study_id