Intermittent Theta Burst Stimulation of the Precuneus

NCT06142422 | Withdrawn

• 1 other identifier: 2023-A01006-39
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores

  The Primary Outcome Measure will be assessed by the average of the Scale for assessment of negative symptoms/scale for assessment of positive symptoms scale scores at approximately 21 days compared to the score at inclusion in the two groups.

  21 days

Study Arms (2)

experimental group with intermittent Theta Burst Stimulation

EXPERIMENTAL

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.

Procedure: stimulation device

control group with placebo stimulation

PLACEBO COMPARATOR

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.

Procedure: stimulation device

Interventions

stimulation device 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; experimental group with intermittent Theta Burst Stimulation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Euraxi Pharma: collaborator
• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Remote coil change while keeping the patient and investigator blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: interventional, prospective, randomized, double-blind, multicenter study

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 21, 2023
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

FR (1)