Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391723
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-01-30
Brief Title:
Clinical Cognitive and Neural Effects of Potentiation of ECT by rTMS in Treatment-Resistant Depression
Sponsor:
Centre Hospitalier du Rouvray
Organization:
Centre Hospitalier du Rouvray
Study Overview
Official Title:
Clinical Cognitive and Neural Effect of Potentiation of Electroconvulsive Therapy ECT by Repetitive Transcranial Magnetic Stimulation rTMS at 10 ECT in Patients With Characterized Pharmacoresistant Depressive Episode
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
STIMAGNECT2
Brief Summary:
Electroconvulsive therapy ECT is one of the most effective treatments for treatment-resistant depression TRD However due to response delay and cognitive impairment ECT remains an imperfect treatment In this multicenter randomized double-blind sham-controlled study our objective is to assess the priming effect of rTMS sessions before ECT on clinical cognitive and neural response in patients with TRD
Detailed Description:
80 patients with TRD will be assigned to active or sham rTMS before ECT treatment Five sessions of activesham rTMS will be administered over the left dorsolateral prefrontal cortex 20 Hz 90 resting motor threshold 20 2 s trains with 60-s intervals 800 pulsessession before ECT which was active for all patients started Then from the sixth ECT session an rTMS session will occur the day before each ECT session Clinical assessment cognitive assessment and brain imaging structural MRI resting state functional MRI MR spectroscopy will take place before and after 10 ECT sessions Clinical cognitive and neural changes will be compared between both groups after 10 ECT sessions
The primary outcome will be the response rate after 10 ECT ie the percentage of patients who achieved a reduction of 50 or more from their initial Hamilton Depression Scale score HAMD-21 items
The primary outcome will be the response rate after 10 ECT ie the percentage of patients who achieved a reduction of 50 or more from their initial Hamilton Depression Scale score HAMD-21 items
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