Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- measure the evolution of the HDRS-17 score
研究概览
简要总结
Repetitive Transcranial Magnetic Stimulation (rTMS) for repetitive Transcranial Magnetic Stimulation) is a a recent technique to stimulate the brain in a way that non-invasive, for therapeutic purposes. The first trials of analgesic use of rTMS date back to about 15 years ago. years and clinical use has now entered the practice of some specialized centers. Used at a frequency less than or equal to 1 Hertz (Hz; a stimulation per second), it is called bass rTMS. frequency and results in inhibition of cortical excitability at the level of the stimulated area. Conversely, a stimulation with a frequency higher than 5 Hz, called high-frequency rTMS, will have an excitatory effect on the targeted neurons. In addition to its local effects at the stimulation site, rTMS can also have effects on distance on regions other than those directly targeted. The impact of this treatment would be the local modulation of the cerebral plasticity and also act on the anatomical connectivity and functional brain function in both healthy subjects and those who are patients with psychiatric disorders
详细描述
Main objective :
To show the effectiveness of rTMS carried out in open on the symptoms of depression resistant in common practice between the Baseline and the end of the initial treatment (between 1 and 6 weeks).
Secondary Objectives
Evaluate the tolerance of the rTMS carried out in open on the symptoms of depression resistant in common practice between the Baseline and the end of the initial cure (between 1 and 6 weeks)
Evaluate the impact of this treatment on :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting a depressive episode characterized as resistant according to the DSM 5 criteria
- •resistance is characterized by: non-response to at least two different antidepressants prescribed at effective doses for a duration greater than or equal to 6 weeks.
- •Patient who agrees to participate in the study and who has signed an informed consent.
- •Patient fluent in French
- •Affiliation to a social security scheme.
- •Women of childbearing age must be on contraception
排除标准
- •Presenting a contraindication to TMS: intrafemale foreign body cranial, unstable epilepsy, cochlear implant, pacemaker, pregnancy
- •Presence of a psychotic disorder
- •Presence of an unstable medical condition
- •Presence of schizophrenia or persistent delusional disorder
- •Persons under guardianship, curatorship and safeguarding of justice.
- •Pregnant women,
- •Woman of childbearing age without effective contraception
- •Breastfeeding woman
结局指标
主要结局
measure the evolution of the HDRS-17 score
时间窗: an average of 1 year
The evolution of the HDRS-17 score (Hamilton depression scale, 17 items) between the Baseline and the end of the initial 4 to 6 week treatment course
次要结局
- Rate of responding patients(an average of 1 year)
- Evolution of the quality of life score(an average of 1 year)
- Rate of patients in remission(an average of 1 year)
研究者
Noomane Bouaziz, MD
psychiatrist
Centre hospitalier de Ville-Evrard, France