Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05526833
Status:
TERMINATED
Last Update Posted:
2024-02-16
First Post:
2022-08-31
Brief Title:
An Extension Protocol for Patients Who Previously Completed the TMS Pilot Study
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
An Open-label Extension Trial of Individualized Repetitive Transcranial Magnetic Stimulation in Patients With Auditory Verbal Hallucinations Who Completed Protocol 8116
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator departed from institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label extension study to continue to evaluate the safety tolerability and efficacy of the Repetitive Transcranial Magnetic Stimulation rTMS in subjects with schizophrenia or schizoaffective disorder who previously completed the treatment study of the protocol 8116 NCT05319080 Protocol 8116 investigates the clinical efficacy of open-label individualized MRI-guided TMS applied to the left temporoparietal junction TPJ in schizophrenia patients Participating patients who have completed the 4-week project 8116 can be screened for eligibility for this extension study in which they will continue treatmentassessment They will be divided into three groups non-responders partial responders or full responders based on a reduction in the Auditory Hallucination Rating Scale AHRS scores from the study 8116
Detailed Description:
The optimal neuroanatomical treatment targets remain unclear though current neuroscience evidence suggests several brain areas such as the left temporo-parietal junction area TPJ or the right posterior superior temporal sulcus rSTS may be involved in the generation and development of AVH During this extension study non-responders to protocol 8116 will be administered 10 days 10 sessions of MRI-guided 1 Hz rTMS delivered to the rSTS instead of the original target in TPJ Partial responders will receive 10 additional low-frequency rTMS over the original left TPJ target Like the protocol 8116 the investigators will use the MRI-guided targeting approach during rTMS treatment sessions to achieve greater precision as it can account for individual differences in anatomy Complete responders will instead be followed for sustainability of response Their clinical ratings will be repeated at one week two week four week and eight week follow-ups Non-responders are defined as patients showing a reduction of AHRS less than 20 of the initial score A partial response is defined as a reduction in a range of between 20 and 50 of the initial AHRS score A complete response is defined as a reduction by at least 50 of the initial AHRS scoreThe combined outcome of protocol 8116 and the currently proposed protocol will help guide TMS targeting and the number of treatment sessions for a future larger randomized double-blinded shame-controlled clinical trial
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23MH119318 | NIH | None | httpsreporternihgovquickSearchK23MH119318 |