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临床试验/NCT01525524
NCT01525524已完成2 期

Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation (TDCS): Randomized, Double-Blind, Clinical Trial

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年1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
48
试验地点
2
主要终点
Treatment response

研究概览

简要总结

Stroke is one of the main public health problems in America Latina. It can be associated with several neuropsychiatric complications, which include a broad spectrum of emotional distress and cognitive, results in important clinical implications for the prognosis of these patients. Depression is a common complication, affecting around 5-72% of patients and is associated with various cognitive deficits and also with increased mortality - up to 50% more deaths compared to non-depressed patients. Treatment of depression after stroke is important not only to improve depressive symptoms but can also be beneficial for cognitive deficits, activities of daily living. and leads to increased survival for these patients. There are different treatments for depression after stroke, all showing inconclusive results, even though antidepressants have been effective in some groups of patients, tolerability and treatment adherence were not very good-so it is necessary that new therapeutic modalities are presented with good tolerability. In this sense, transcranial direct current stimulation (tDCS) is an interesting technique that can provide interesting results, which proved to be effective for depression in some studies. This study proposes to investigate the effect of tDCS for the treatment of major depressive disorder after stroke. The proposed design is a clinical trial, randomized, double-blind, placebo-controlled study in a subsample of participants in the prospective cohort of stroke: Study of Morbidity and Mortality of stroke. They will be allocated to one of the groups: sham or active tDCS group. Participants will receive ten consecutive days of active or sham stimulation and return at the end of two weeks to evaluate the improvement in depression, cognition and functionality. As objectives, the investigators expect to see a clinical improvement of depression through scales like Hamilton, Beck and MADRS(Montgomery-Asberg Depression Rating Scale), and expect improvement on cognitive tests as MoCA (Montreal Cognitive Assessment), MMSE (mini mental scale exam), FAB (frontal assessment battery) and trail test. Another goal is to see improvement in markers related to depression as BDNF, cortisol, interleukins and heart rate variability. With all this, the investigators hope to offer a new treatment, and effective with few side effects to treat depression after stroke.

详细描述

The Study of Morbidity and Mortality of stroke (EMMA) is a cohort study of patients with stroke.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major Depressive Disorder after stroke
  • First episode of Stroke
  • Hamilton > 17

排除标准

  • Others severe neurologic conditions
  • Others Axis I besides anxiety
  • Important suicidal ideation
  • Use of antidepressants

研究组 & 干预措施

Sham Stimulation

Sham Comparator

In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex with the Transcranial Direct Current Stimulation. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp. The device will deliver a charge of 2mA for 1 minute, after that the device will be automatically turned off for 29 minutes.

干预措施: Transcranial Direct Current Stimulation (Device)

Active Stimulation

Active Comparator

In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex with the transcranial Direct Current Stimulation device. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp. The device will deliver a charge of 2mA for 30 minutes.

干预措施: Transcranial Direct Current Stimulation (Device)

结局指标

主要结局

Treatment response

时间窗: Week 4 after tenth day of tDCS

Hamilton of active will be lower than sham group

次要结局

  • Treatment response(Week 4 after tenth day of tDCS)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leandro Valiengo

Principal Investigator

University of Sao Paulo

研究点 (2)

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