Clinical Trial on Efficacy of Repeated Transcranial Magnetic Stimulation (rTMS) to Improve Electroconvulsive Therapy (ECT) in Treatment-Resistant Depression (TRD): STIMAGNECT Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 56
- Locations
- 3
- Primary Endpoint
- Relative improvement of the Hamilton Rating Scale for Depression 21-items score
Study Overview
Brief Summary
It's a prospective, multicentric, randomized, controlled study concerning 56 patients with treatment-resistant depression (TRD). The main objective of this study was to evaluate the efficacy of priming repeated Transcranial Magnetic Stimulation (rTMS) sessions before Electroconvulsive therapy (ECT) for treatment of TRD patients. The primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating Scale For Depression (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the safety and most particularly the cognitive effects of this association.
Detailed Description
Included patients are adults, aged between 18 and 70 years, with major depression (Hamilton Rating scale for Depression, HAMD ≥ 15). Patients don't have any experience concerning repeated Transcranial Magnetic Stimulation (rTMS).
Patients with treatment-resistant depression (TRD) were assigned to two treatment groups in addition to their current pharmacotherapy regimen : one group received 5 active-rTMS before Electroconvulsive therapy (ECT) and the other one received sham-rTMS before ECT. The depressive symptoms and the cognitive functions are evaluated before rTMS, after 5 rTMS and after 5 ECT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with Major Depressive Disorder (HAMD≥15)
- •Level of resistance ≥ 3 (Thase and Rush)
- •Participants who gave their informed, written consent
Exclusion Criteria
- •Contraindication of Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia
- •History of epilepsy; severe neurological or systemic disorder that could significantly affect cognition
- •Pregnancy
Arms & Interventions
active rTMS-ECT
5 active high frequency rTMS before 5 bilateral ECT
Intervention: active rTMS-ECT (Device)
sham rTMS-ECT
5 sham rTMS before 5 bilateral ECT
Intervention: sham rTMS-ECT (Device)
Outcomes
Primary Outcomes
Relative improvement of the Hamilton Rating Scale for Depression 21-items score
Time Frame: Relative improvement of the Hamilton Rating Scale for Depression score between the inclusion and 19 days after the inclusion
Secondary Outcomes
No secondary outcomes reported
Investigators
Maud Rothärmel
M.D.
Centre Hospitalier du Rouvray