Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Clinical Study Coupled With Positon Emission Tomography (PET)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Pharmacoresistant Depression

Treatments: Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro®; Device: Positon Emission Tomography (PET) - Discovery 710®

Study type: Interventional

Funder types: Other

Identifiers

NCT02559466

RCAPHM15_0084 (Other Identifier)

2015-08

2015-A00345-44 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who met the diagnosis of major depressive episode (MDE)
• Patient right-handed
• Men and women aged over 18 years with major depressive episode IV (DSM-IV criteria), isolated or recurrent.
• Scores on the scale MADRS> 20
• Resistance Criterion defined as the failure of two antidepressants effective dose for a minimum of six weeks.
• Drug Therapy stable for at least 2 weeks

Exclusion criteria

• Bipolar disorder type I or type II
• Depression With Psychotic Features
• Diagnosis according comorbid Axis I (DSM IV) with schizophrenia, alcohol abuse and / or toxic substances.
• Inpatient under stress or under legal protection measure (guardianship, curatorship)
• Counter to the practice of Transcranial Magnetic Stimulation : a personal history of seizure, history of neurological or neurosurgical pathologies, metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.).
• Pregnant or breastfeeding ongoing.
• Somatic disorder may affect cognitive abilities and brain structures
• Known allergy to any component of Fludeoxyglucose

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Patients stimulated with a H-TMS (deep)

Experimental group

Description:

20 sessions navigated with Deep Transcranial Magnetic Stimulation

Treatment:

Device: Positon Emission Tomography (PET) - Discovery 710®

Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro®

Patients stimulated with a conventional TMS

Other group

Description:

20 sessions navigated with Conventional Transcranial Magnetic Stimulation

Treatment:

Device: Positon Emission Tomography (PET) - Discovery 710®

Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro®