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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-17

Study Completion Date

2023-05-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Pharmacoresistant Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Patients stimulated with a H-TMS (deep)

20 sessions navigated with Deep Transcranial Magnetic Stimulation

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (TMS - ) - MagPro®

Intervention Type DEVICE

Class IIa

Positon Emission Tomography (PET) - Discovery 710®

Intervention Type DEVICE

Class IB

Patients stimulated with a conventional TMS

20 sessions navigated with Conventional Transcranial Magnetic Stimulation

Group Type OTHER

Transcranial Magnetic Stimulation (TMS - ) - MagPro®

Intervention Type DEVICE

Class IIa

Positon Emission Tomography (PET) - Discovery 710®

Intervention Type DEVICE

Class IB

Interventions

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Transcranial Magnetic Stimulation (TMS - ) - MagPro®

Class IIa

Intervention Type DEVICE

Positon Emission Tomography (PET) - Discovery 710®

Class IB

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No