Intermittent Theta Burst Stimulation of the Precuneus

Schizophrenia Clinical Trial

— Stim-TISiTBS  

Official title:

Intermittent Theta Burst Stimulation of the Precuneus for the Treatment of Resistant Schizophrenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06142422
• Other study ID #: 2023-A01006-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Aïda CANCEL, MD
• Phone: 625488144
• Email: aida.cancel[@]hotmail.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Clinique Rech	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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