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临床试验/NCT03656900
NCT03656900已完成2 期

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.

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2010年2月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
17
试验地点
2
主要终点
The remission rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

BA9/BA46

Experimental

干预措施: rTMS BA9/BA46 (Device)

BA9/BA46

Experimental

干预措施: brain MRI (Radiation)

BA9/BA46

Experimental

干预措施: Medical evaluation (Other)

BA9/BA46

Experimental

干预措施: Psychological assessment (Other)

BA46/BA9

Experimental

干预措施: rTMS BA46/BA9 (Device)

BA46/BA9

Experimental

干预措施: brain MRI (Radiation)

BA46/BA9

Experimental

干预措施: Medical evaluation (Other)

BA46/BA9

Experimental

干预措施: Psychological assessment (Other)

结局指标

主要结局

The remission rate

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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