Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-18
First Post:
2020-08-05
Brief Title:
Targeted Intervention Study of dTMS on Impaired Insight in Early Psychosis
Sponsor:
Shanghai Mental Health Center
Organization:
Shanghai Mental Health Center
Study Overview
Official Title:
A Study on Targeted Intervention for Insight in Patients With First Episode and Clinical High Risk of Schizophrenia Based on Theta Oscillation in Anterior Cingulate Cortex
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
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:
None
Brief Summary:
Impaired insight is a key factor in the conversion of high-risk individuals to schizophrenia but there is a lack of targeted interventions We found that an electroencephalogram EEG signal reflecting the function of self monitoring was a potential objective marker of impaired insight And further functional magnetic resonance imaging fMRI analysis showed that the functional connectivity between anterior cingulate gyrus ACC and medial temporal gyrus MTG was related to insight Studies have shown that ACC theta oscillation is the key to self monitoring and theta-alpha phase synchronization between frontotemporal is closely related to cognition Therefore this project hypothesized that targeted regulation of ACC theta oscillations could promote theta-alpha phase synchronization and functional connectivity between ACC and MTG thereby improving patients insight The first-episode and high-risk subjects were recruited to detect the theta oscillation of ACC theta-Alpha phase synchronization and functional connectivity between ACC and MTG using EEG-fMRI Deep transcranial magnetic stimulation was introduced to regulate ACC theta oscillations The high-risk subjects were followed up for two years It was estimated that the theta-alpha phase synchronization of ACC-MTG and insight in the active-dTMS group were significantly improved And the outcome of the high-risk subjects is better The project develops neuroregulatory techniques for impaired insight of schizophrenia and is expected to provide a solution for this clinical pain point
Detailed Description:
The study will conduct randomized and controlled experimental design including deep transcranial magnetic stimulation dTMS and sham stimulation SH-dTMS Each included participant will be given informed consent and then randomly assigned to different montage of stimulation Participants are blind to the dTMS montage Researchers in this study will include clinical evaluators laboratory inspectors dTMS operators and statistical analysts Before unblinding each group of researchers will have no access to the information collected by the other groups For example except the dTMS operators no one knows which stimulus montage any of the participants receive The sessions of dTMS will be conducted twice daily for 5 consecutive days and twice sessions of a day will be separated by 3 hours at least Clinical assessments and laboratory tests will be administered at baseline and at the end of the last session After the post-intervention tests first stage unblinding will be conducted At this moment dTMS operators will provide the groups of A and B but no corresponding montage to the statistical analysts After analyzing the differences between the two groups second stage unblinding will be performed and the results of the clinical trial will be further analyzed by revealing the corresponding stimulus montage of each group This study will be implemented at a single center the Shanghai Mental Health Center SMHC
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