Efficacy of Deep Transcranial Magnetic Stimulation (TMS)... | NCT02559466

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

NCT02559466

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

May 24, 2023Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Pharmacoresistant Depression

Interventions

Transcranial Magnetic Stimulation (TMS - ) - MagPro®
Positon Emission Tomography (PET) - Discovery 710®

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
RCAPHM15_0084	Other Identifier	APHM
2015-A00345-44	Registry Identifier	ID RCB

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2015Actual

Primary Completion Date

Apr 18, 2018Actual

Completion Date

May 23, 2023Actual

First Submitted Date

Sep 23, 2015

First Submission Date that Met QC Criteria

Sep 23, 2015

First Posted Date

Sep 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2023

Last Update Posted Date

May 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients stimulated with a H-TMS (deep)	Experimental	20 sessions navigated with Deep Transcranial Magnetic Stimulation	Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro® Device: Positon Emission Tomography (PET) - Discovery 710®
Patients stimulated with a conventional TMS	Other	20 sessions navigated with Conventional Transcranial Magnetic Stimulation	Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro® Device: Positon Emission Tomography (PET) - Discovery 710®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Magnetic Stimulation (TMS - ) - MagPro®	Device	Class IIa	Patients stimulated with a H-TMS (deep) Patients stimulated with a conventional TMS

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urielle DESALBRES, Director	Assistance Publique Hôpitaux de Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hôpitaux de Marseille		Marseille		13354	France

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics