Monocentric Pilot Study, for a Randomized, Crossover, Blinded Trial: Comparison of the Therapeutic Efficacy of Low Frequency Repeated Transcranial Magnetic Stimulation on Cortical Area 9 Compared to Brodmann Area 46 in the Treatment of Depressive Disorders.

Phase 2

Completed

• Conditions: Patients With Resistant Depressive Disorders
• Interventions: Device: rTMS BA9/BA46; Device: rTMS BA46/BA9; Radiation: brain MRI; Other: Medical evaluation; Other: Psychological assessment

• Registration Number: NCT03656900
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) is a new therapeutic tool used in psychiatry. Non-invasive, well tolerated and requiring no premedication, it is performed on an outpatient basis. The principle of this technique is to stimulate the cerebral cortex from an electromagnetic coil placed on the scalp. Unlike electroconvulsive therapy, rTMS induces an electrical current on a well-defined region of the cerebral cortex.

In psychiatry, this technique is mainly considered in the treatment of depressive disorders resistant to antidepressant medication. The brain target, obtained from brain imaging data in depressed patients, is the dorsolateral prefrontal cortex (DLPFC). The Food and Drug Administration (FDA) has recognized the interest of rTMS for treating depressive disorders (October 7, 2008).

However, some stimulation parameters still need to be optimized before rTMS can be considered a therapeutic method in its own right and used routinely. Indeed, its effectiveness over time has not yet been evaluated, and rTMS has shown a lack of reproducibility between subjects \[Foucher, 2007\]. Finally, the therapeutic results of rTMS are very modest whatever the study \[Daskalakis, 2008\]. Additional studies are therefore needed to optimize stimulation parameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-02
• Study Completion: 2013-10
• Status Verified: 2018-08
• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-08-31
• Last Update Submitted: 2018-08-31
• Study First Posted: 2018-09-04
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Patients with resistant depressive disorders (Hamilton-17-item scale > 22, failure ≥ 2 antidepressants) with at least one of the following criteria :

• venlafaxine treatment failure (unlike the national PHRC, patients who receive/have received venlafaxine treatment for the current depressive episode are included),
• therapeutic failure in PHRC national rTMS 2007,
• refusal to participate in the PHRC national rTMS 2007.

Exclusion Criteria

• Bipolar disorders: type I or II,
• Depression with psychotic characteristics,
• Schizophrenia,
• Risky or harmful use of alcohol and/or an illicit psychoactive substance,
• Dependence on alcohol and/or an illicit psychoactive substance,
• Sick and hospitalized under duress or under legal protection (guardianship, curatorship),
• Contraindication to the practice of rTMS; personal history of seizures, history of neurological or neurosurgical pathologies, metallic prosthetic materials or foreign bodies (pacemaker, etc...),
• Contraindication to brain MRI,
• Pregnancy or breastfeeding in progress
• Resistance to Escitalopram

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BA9/BA46	brain MRI	-
BA9/BA46	Psychological assessment	-
BA9/BA46	rTMS BA9/BA46	-
BA9/BA46	Medical evaluation	-
BA46/BA9	brain MRI	-
BA46/BA9	Psychological assessment	-
BA46/BA9	rTMS BA46/BA9	-
BA46/BA9	Medical evaluation	-

Primary Outcome Measures

Name	Time	Method
The remission rate	Through study completion, an average of 11 weeks.	Compare the remission rates (decrease \< 50% of the HDRS score / initial score) during neuronavigated stimulations on BA 9 and BA 46 compared to the average rate obtained during manual stimulation.

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France