Trials / Completed
CompletedNCT02559466
Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Clinical Study Coupled With Positon Emission Tomography (PET)
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcranial Magnetic Stimulation (TMS - ) - MagPro® | Class IIa |
| DEVICE | Positon Emission Tomography (PET) - Discovery 710® | Class IB |
Timeline
- Start date
- 2015-07-17
- Primary completion
- 2018-04-18
- Completion
- 2023-05-23
- First posted
- 2015-09-24
- Last updated
- 2023-05-24
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02559466. Inclusion in this directory is not an endorsement.