Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357832
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-05
Brief Title:
New Investigational Stimulation Protocol for Treatment of Major Depression Disorder MDD
Sponsor:
Brainsway
Organization:
Brainsway
Study Overview
Official Title:
A Prospective Randomized Controlled Multicenter Trial to Evaluate the Safety and Efficacy of Deep Transcranial Magnetic Stimulation Deep TMS With a New Stimulation Protocol in Subjects With Major Depression Disorder MDD
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The BrainsWay Deep Transcranial Magnetic Stimulation Depp TMS device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder MDD The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency The purpose of the current study is to evaluate the safety and effectiveness of a new investigational stimulation protocol delivered with the BrainsWay Deep TMS device for the treatment of MDD demonstrating that it is non-inferior to the current standard-of-care stimulation protocol in a randomized controlled study
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?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None