Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06142422
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-11-16
Brief Title:
Intermittent Theta Burst Stimulation of the Precuneus
Sponsor:
GCS Ramsay Santé pour lEnseignement et la Recherche
Organization:
GCS Ramsay Santé pour lEnseignement et la Recherche
Study Overview
Official Title:
Intermittent Theta Burst Stimulation of the Precuneus for the Treatment of Resistant Schizophrenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Stim-TISiTBS
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None