NCT06142422

Intermittent Theta Burst Stimulation of the Precuneus

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-11-21
• Last updated: 2026-01-14

Locations

1 site across 1 country: France