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Completed

NCT Number: NCT03656900

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.

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.

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Key information

Conditions

Patients With Resistant Depressive Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTMS BA9/BA46

Device

10 sessions of low-frequency repeated transcranial magnetic stimulation over two weeks on cortical area 9, then 4 weeks wash-out, then 10 sessions of low-frequency repeated transcranial magnetic stimulation repeated low frequency over two weeks on cortical area 46.

rTMS BA46/BA9

Device

10 sessions of low-frequency repeated transcranial magnetic stimulation over two weeks on cortical area 46, then 4 weeks wash-out, then 10 sessions of low-frequency repeated transcranial magnetic stimulation repeated low frequency over two weeks on cortical area 9.

brain MRI

Radiation

T1 weighted full-head high-resolution MRI with 1 mm seam cuts and sagittal orientation.

Medical evaluation

Other

complete evaluation with 6 scales (HDRS, MADRS, Beck, CGI, COVI, UKU)

psychological assessment

Other

Subjective Life Profile Assessment (SLPA) and Helping Alliance Assessment

Primary outcomes

  1. The remission rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: rTMS

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Sep 4, 2018
Registry last updated
Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.