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. (rTMS)

University Hospital Center (CHU) Dijon Bourgogne

Status and phase: Completed; Phase 2

Conditions: Patients With Resistant Depressive Disorders

Treatments: Device: rTMS BA46/BA9; Device: rTMS BA9/BA46; Other: Psychological assessment; Radiation: brain MRI; Other: Medical evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT03656900

TROJAK 2009

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 2 patient groups

BA9/BA46

Experimental group

Treatment:

Device: rTMS BA9/BA46

Other: Psychological assessment

Other: Medical evaluation

Radiation: brain MRI

BA46/BA9

Experimental group

Treatment:

Device: rTMS BA46/BA9

Other: Psychological assessment

Other: Medical evaluation

Radiation: brain MRI