Completed

NCT Number: NCT02559466

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

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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Key information

Conditions

Pharmacoresistant Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation (TMS - ) - MagPro®

Device

Class IIa

Positon Emission Tomography (PET) - Discovery 710®

Device

Class IB

Primary outcomes

The depression score in Montgomery-Åsberg Depression Rating Scale (MADRS).

Time frame: 24 month

performed before and after TMS

Secondary outcomes

Short self-completion questionnaire on symptoms of depression

Time frame: 24 month

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2023
First posted: Sep 24, 2015
Registry last updated: May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.