Ignite Creation Date:
2024-05-06 @ 7:32 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02559466
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2015-09-23
Brief Title:
Efficacy of Deep Transcranial Magnetic Stimulation TMS for Treatment-resistant Depression and Neuroanatomical Correlates a Clinical Study Coupled With Positon Emission Tomography PET
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Efficacy of Deep Transcranial Magnetic Stimulation TMS for Treatment-resistant Depression and Neuroanatomical Correlates a Randomized Clinical Study Coupled With Positon Emission Tomography PET
Status:
COMPLETED
Status Verified Date:
2023-05
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:
Repetitive transcranial magnetic stimulation TMS is an emergent non-invasive treatment for treatment resistant depression TRD The exact neuro-functional mechanisms related to TMS efficiency remains however unknown besides local effect on the target TMS may induce interaction changes between remote cerebral regions On the other hand few studies have been performed in comparison to sham placebo stimulation The investigators recently showed that non-responder depressive patients to TMS exhibited deeper and wider brain functional abnormalities hardly reachable by standard coils The H1-Coil is a novel TMS H-TMS device capable of inducing a magnetic field with a deeper and wider distribution than standard coils
The investigators design here a randomized controlled study in which the investigators will compare the clinical effects of H-coil TMS and standard TMS in patients with TRD and their functional neuroanatomical correlates and changes in connectivity by Positron Emission Tomography PET The general objective is to better understand the mechanisms related to TMS efficiency in pharmacoresistant depression in order to propose the best therapeutic approach for the patient
The investigators design here a randomized controlled study in which the investigators will compare the clinical effects of H-coil TMS and standard TMS in patients with TRD and their functional neuroanatomical correlates and changes in connectivity by Positron Emission Tomography PET The general objective is to better understand the mechanisms related to TMS efficiency in pharmacoresistant depression in order to propose the best therapeutic approach for the patient
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-A00345-44 | REGISTRY | ID RCB | None |
| RCAPHM15_0084 | OTHER | None | None |