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临床试验/NCT01896791
NCT01896791已完成不适用

Transcranial Direct Current Stimulation (tDCS) in Vasomotor Symptoms of Menopause: Blind Sham Controlled Randomized Clinical Trial

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
number of diary vasomotor symptoms

研究概览

简要总结

Climacteric or Menopausal Transition is defined as the time period where there is a change to non-reproductive reproductive life, with extension of variable length. During this period, and after the establishment of Menopause and non-functioning ovarian, the appearance of various symptoms that express the depletion of ovarian follicles is common; among these symptoms, the most frequently reported by women are vasomotor symptoms or hot flashes. In addition to hormonal therapy, other medications have been employed in an attempt to improve these symptoms; although they present better results than placebo, yet have little clinical impact in reducing vasomotor symptoms. Therefore, this gap allows the evaluation of alternative therapies, such as Transcranial Direct Current Stimulation (tDCS). The rationale for studying the effect of this technique in this context is its possible autonomic modulatory effect. What reinforces the choice of this technique is the fact that it demonstrated efficacy in other pathologies such as depression, pain, Parkinson's disease, among others. Transcranial direct current stimulation (tDCS) is a renewed method of non-invasive brain modulation. It is based on a transcranial application of weak direct currents in a non-invasive, simple and painless manner. Its use in the treatment of vasomotor symptoms has not been studied. The objective of this study is to evaluate the improvement of vasomotor symptoms in postmenopausal women, after application of tDCS, and compare them to a control group. This Randomized Clinical Trial will be held in female postmenopausal patients, followed in the outpatient Menopause Clinic of Obstetrics and Gynecology Service, Hospital de Clinicas de Porto Alegre. From these results, it is expected to present a new therapeutic option in the treatment of vasomotor symptoms.

详细描述

Primary Outcome: evaluate the effect of tDCS on vasomotor symptoms in postmenopausal women treated at a tertiary hospital in southern Brazil.

Secondary Outcome: compare the effect of tDCS with sham-tDCS in postmenopausal women on vasomotor symptoms, FSH (Follicle Stimulating Hormone) levels, salivary cortisol, BDNF (Brains derived neurotrophic factor)levels,depressive symptoms and quality of life.

Interventions:

  • Application of tDCS for a period of 10 consecutive days.
  • Transcranial direct current stimulation (tDCS):

Active stimulation: the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: 2 mili Ampere, 20min, 10 days.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • menopause women, any age, with at least, eight hot flashes/day

排除标准

  • neurological or psychiatric diseases, patients with head injury, women in hormonal replacement

研究组 & 干预措施

Transcranial Direct Current Stimulation

Active Comparator

Active Transcranial Direct Current Stimulation: the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: tDCS: 2mili Ampere, 20min, 10 days.

干预措施: Transcranial Direct Current Stimulation (Procedure)

Sham Stimulation

Placebo Comparator

Sham Stimulation: appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation

干预措施: Sham Stimulation (Procedure)

结局指标

主要结局

number of diary vasomotor symptoms

时间窗: 30 days

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 (1)

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