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

May 23, 2023 updated by: Assistance Publique Hopitaux De Marseille

Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Randomized 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients stimulated with a H-TMS (deep)
20 sessions navigated with Deep Transcranial Magnetic Stimulation
Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro®
Class IIa
Device: Positon Emission Tomography (PET) - Discovery 710®
Class IB
Other: Patients stimulated with a conventional TMS
20 sessions navigated with Conventional Transcranial Magnetic Stimulation
Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro®
Class IIa
Device: Positon Emission Tomography (PET) - Discovery 710®
Class IB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The depression score in Montgomery-Åsberg Depression Rating Scale (MADRS).
Time Frame: 24 month
performed before and after TMS
24 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Short self-completion questionnaire on symptoms of depression
Time Frame: 24 month
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Urielle DESALBRES, Director, Assistance Publique Hopitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2015

Primary Completion (Actual)

April 18, 2018

Study Completion (Actual)

May 23, 2023

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-08
  • RCAPHM15_0084 (Other Identifier: APHM)
  • 2015-A00345-44 (Registry Identifier: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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