Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04956016
Status:
RECRUITING
Last Update Posted:
2023-01-19
First Post:
2021-06-29
Brief Title:
Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment
Sponsor:
Centre Hospitalier Henri Laborit
Organization:
Centre Hospitalier Henri Laborit
Study Overview
Official Title:
Open-label Randomized Comparative Study of the Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment in the Management of Resistant Depression
Status:
RECRUITING
Status Verified Date:
2024-08
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:
HAUVERDEEP
Brief Summary:
The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil
The patient will receive treatment arm A or B
Arm A classic rTMS treatment use of the 8-shaped coil and standard therapy Arm B treatment with deep rTMS use of the H-shaped coil helmet and standard therapies
20 rTMS sessions are planned 5 sessions per week and 3 follow-up visits at Day 30 Day 60 and Day 90
The patient will receive treatment arm A or B
Arm A classic rTMS treatment use of the 8-shaped coil and standard therapy Arm B treatment with deep rTMS use of the H-shaped coil helmet and standard therapies
20 rTMS sessions are planned 5 sessions per week and 3 follow-up visits at Day 30 Day 60 and Day 90
Detailed Description:
None
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