Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118268
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-04
Brief Title:
iTBS to Enhance Social Cognition in People With Psychosis
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
iTBS to Enhance Social Cognition in People With Psychosis
Status:
RECRUITING
Status Verified Date:
2023-11
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:
iSCIP
Brief Summary:
The goal of this clinical trial is to examine if iTBS applied to the DMPFC improves social cognitive performance compared to sham stimulation in people diagnosed with schizophrenia schizoaffective disorder schizophreniform disorder or psychotic disorder not otherwise specified The main objectives of this trial are
Compare changes in social cognitive performance between the active vs sham treatment groups
Compare changes in social cognitive network functional connectivity between the active vs sham treatment groups
Each participant will receive iTBS active or sham five days per week for four consecutive weeks Functional magnetic resonance imaging fMRI scans clinical assessments and cognitive tests will be performed at pre-treatment post-treatment and 6 months after the completion of treatment
Compare changes in social cognitive performance between the active vs sham treatment groups
Compare changes in social cognitive network functional connectivity between the active vs sham treatment groups
Each participant will receive iTBS active or sham five days per week for four consecutive weeks Functional magnetic resonance imaging fMRI scans clinical assessments and cognitive tests will be performed at pre-treatment post-treatment and 6 months after the completion of treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None