Ignite Creation Date:
2024-05-06 @ 12:10 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01501825
Status:
UNKNOWN
Last Update Posted:
2012-07-04
First Post:
2011-12-27
Brief Title:
A Prospective Comparative Study to Explore the Efficacy and Safety of the Five Channels Multiway Deep Transcranial Magnetic Stimulation TMS Device in Subjects With Major Depression Disorder MDD
Sponsor:
Shalvata Mental Health Center
Organization:
Shalvata Mental Health Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2011-12
Last Known Status:
NOT_YET_RECRUITING
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 Multiway stimulator is a novel TMS stimulator with several new and unique properties Currently standard TMS devices include a single channel and can operate only a single coil The Multiway stimulator includes five channels which can operate up to five independent TMS coils either simultaneously or sequentially
The Multiway device may be used to obtain a differential activation of various brain regions For instance it can be used to induce high frequency stimulation of a certain brain region thus inducing facilitation while simultaneously stimulate at low frequency in another brain region leading to inhibition
The purpose of the study is to explore the efficacy and safety of Multiway deep TMS in comparison to a single channel DTMS treatment in subjects with MDD
Subjects will be treated with one of two designs of the study device the Multiway Coil TMS Device
1 Single Channel with a coil placed over the left PFC 10 Hz
2 Four channels a 10 Hz over the left PFC b 1 Hz over the right PFC c 10 Hz over the left parietal cortex d 1 Hz over the right parietal cortex
The Multiway device may be used to obtain a differential activation of various brain regions For instance it can be used to induce high frequency stimulation of a certain brain region thus inducing facilitation while simultaneously stimulate at low frequency in another brain region leading to inhibition
The purpose of the study is to explore the efficacy and safety of Multiway deep TMS in comparison to a single channel DTMS treatment in subjects with MDD
Subjects will be treated with one of two designs of the study device the Multiway Coil TMS Device
1 Single Channel with a coil placed over the left PFC 10 Hz
2 Four channels a 10 Hz over the left PFC b 1 Hz over the right PFC c 10 Hz over the left parietal cortex d 1 Hz over the right parietal cortex
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None