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

Primary Purpose

Pharmacoresistant Depression

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS - ) - MagPro®
Positon Emission Tomography (PET) - Discovery 710®
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharmacoresistant Depression focused on measuring pharmaco-resistant depressed patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patients stimulated with a H-TMS (deep)

Patients stimulated with a conventional TMS

Arm Description

20 sessions navigated with Deep Transcranial Magnetic Stimulation

20 sessions navigated with Conventional Transcranial Magnetic Stimulation

Outcomes

Primary Outcome Measures

The depression score in Montgomery-Åsberg Depression Rating Scale (MADRS).
performed before and after TMS

Secondary Outcome Measures

Short self-completion questionnaire on symptoms of depression

Full Information

First Posted
September 23, 2015
Last Updated
May 23, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02559466
Brief Title
Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Clinical Study Coupled With Positon Emission Tomography (PET)
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2015 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
May 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharmacoresistant Depression
Keywords
pharmaco-resistant depressed patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients stimulated with a H-TMS (deep)
Arm Type
Experimental
Arm Description
20 sessions navigated with Deep Transcranial Magnetic Stimulation
Arm Title
Patients stimulated with a conventional TMS
Arm Type
Other
Arm Description
20 sessions navigated with Conventional Transcranial Magnetic Stimulation
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS - ) - MagPro®
Intervention Description
Class IIa
Intervention Type
Device
Intervention Name(s)
Positon Emission Tomography (PET) - Discovery 710®
Intervention Description
Class IB
Primary Outcome Measure Information:
Title
The depression score in Montgomery-Åsberg Depression Rating Scale (MADRS).
Description
performed before and after TMS
Time Frame
24 month
Secondary Outcome Measure Information:
Title
Short self-completion questionnaire on symptoms of depression
Time Frame
24 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES, Director
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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