Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190216
Status:
TERMINATED
Last Update Posted:
2007-11-08
First Post:
2005-09-13
Brief Title:
Assessing Repetitive Transcranial Magnetic Stimulation as a Treatment for Refractory Depression rTMS
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Assessing Repetitive Transcranial Magnetic Stimulation as a Treatment for Refractory Depression
Status:
TERMINATED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypothesis of this study was that transcranial magnetic stimulation TMS focused on hyperfunctional cerebral areas should be more effective in treating depressive symptoms than stimulations not taking into account the functional specificity of the patient The goal was to compare the effects of guided TMS using neuroimaging to guide TMS on dysfunctional cortical regions individually detected by neuroimaging with standard TMS as used in most studies over the left prefrontal cortex and with sham TMS in patients with resistant depression
Detailed Description:
The objectives of the study were
To localize the site of lowest frontal activity in each patient with resistant depression using PET to measure regional cerebral metabolic rates for glucose rCMRGlu
To demonstrate that high-frequency TMS 10Hz guided on that site is more effective than standard or sham TMS in resistant depressed patients using a doubled blind controlled procedure
To assess the effects of TMS on regional cerebral metabolism using rCMRGlu PET after 10 sessions of TMS treatments
Depressed patients meeting DSM-IV criteria for Major Depressive Disorder aged between 18 and 55 have been included They met criteria for depression resistant to antidepressant drugs They were randomised in 3 groups guided prefrontal TMS standard left prefrontal and sham left prefrontal TMS
rTMS was administered daily on working days for two weeks Ten stimuli per second 10Hz were applied in 20 courses so that patients received 1600 stimuli per day Guided TMS was on a prefrontal target corresponding to the highest statistically significant hyperfunctional cluster determined with rCMRGlu PET Standard stimulation was left pre-frontal 5 cm anterior to the optimal stimulation point of the abductor pollices brevis Stimulation strength was chosen at 90 relative to motor threshold Sham rTMS used a procedure identical to the real standard treatment but using a sham coil
To localize the site of lowest frontal activity in each patient with resistant depression using PET to measure regional cerebral metabolic rates for glucose rCMRGlu
To demonstrate that high-frequency TMS 10Hz guided on that site is more effective than standard or sham TMS in resistant depressed patients using a doubled blind controlled procedure
To assess the effects of TMS on regional cerebral metabolism using rCMRGlu PET after 10 sessions of TMS treatments
Depressed patients meeting DSM-IV criteria for Major Depressive Disorder aged between 18 and 55 have been included They met criteria for depression resistant to antidepressant drugs They were randomised in 3 groups guided prefrontal TMS standard left prefrontal and sham left prefrontal TMS
rTMS was administered daily on working days for two weeks Ten stimuli per second 10Hz were applied in 20 courses so that patients received 1600 stimuli per day Guided TMS was on a prefrontal target corresponding to the highest statistically significant hyperfunctional cluster determined with rCMRGlu PET Standard stimulation was left pre-frontal 5 cm anterior to the optimal stimulation point of the abductor pollices brevis Stimulation strength was chosen at 90 relative to motor threshold Sham rTMS used a procedure identical to the real standard treatment but using a sham coil
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 |
|---|---|---|---|
| P000606 | None | None | None |