Montage of HTDCS in Psycho-cognitive Functions in FM (HFTDCS)
2021年5月12日 更新者：Hospital de Clinicas de Porto Alegre
Mapping the Impact of the Montage of the Transcranial Direct Current Stimulation at Home at Cortical and Psycho-cognitive Functions, Functional Capacity and Biological Rhythm in the Fibromyalgia: A Randomized, Factorial, Clinical Trial
This study aims to map the impact of anodic transcranial direct current stimulation (tDCS) for prolonged home use applied to the primary motor cortex and the left dorsolateral prefrontal córtex (DLPFC), compared to the respective treatments simulated in fibromyalgia.
研究概览
详细说明
This study aims to map the impact of anodic tDCS for prolonged home use applied to the primary motor cortex and the left dorsolateral prefrontal córtex (DLPFC), compared to the respective treatments simulated in fibromyalgia, targeting the outcomes of the following axes: (1) pain intensity and functional capacity; (2) psycho cognitive functions; (3) neurophysiological markers; (4) biological rhythm markers; (5) to map the potential of neurophysiological markers, biological rhythm and history of trauma in childhood and adolescence in functional capacity, depressive symptoms and working memory tests.
研究类型
介入性
注册 (预期的)
66
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Wolnei Caumo, Dr.
- 电话号码：+555199813977
- 邮箱：wcaumo@hcpa.edu.br
学习地点
-
-
Rio Grande Do Sul
-
Porto Alegre、Rio Grande Do Sul、巴西、90.450-120
- 招聘中
- Hospital de Clinicas de Porto Alegre
-
接触：
- Wolnei Caumo, PhD
- 电话号码：+5551 3359 6377
- 邮箱：wcaumo@hcpa.edu.br
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Women aged 30 to 65 years; who can read and write, with a confirmed diagnosis of FM according to the criteria of the American College of Rheumatology (2010-2016). Pain score equal to or greater than six on the Numeric Pain Scale (NPS 0-10) on most days in the last 3 months.
Exclusion Criteria:
- Living outside Porto Alegre area and pregnancy.
- Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemaker; aneurysmal clip; metallic cochlear prosthesis, ear implants, and non-removable hearing aids; infusion pumps (including implantable); cranial halos. Pregnant women, shift work, use of exogenous melatonin, history of alcohol or drug abuse in the last 6 months, neurological pathologies, history of head trauma or neurosurgery, decompensated systemic chronic diseases, chronic inflammatory diseases (lupus, rheumatoid arthritis, Reiter's syndrome), personal history of cancer, past or under treatment.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Transcranial Direct Current Stimulation (tDCS), Active Stimulation - DLPFC
Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days.
|
A stimulation device, that releases 2.0mA current by a 35 cm2 electrode direct located on a specific location on the scalp for 20 minutes
其他名称：
|
|
假比较器：Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - DLPFC
Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days.
|
A stimulation device, that releases 2.0mA current by a 35 cm2 electrode direct located on a specific location on the scalp for 20 minutes
其他名称：
|
|
有源比较器：Transcranial Direct Current Stimulation (tDCS), Active Stimulation - M1
Participants received Active stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days.
|
A stimulation device, that releases 2.0mA current by a 35 cm2 electrode direct located on a specific location on the scalp for 20 minutes
其他名称：
|
|
安慰剂比较：Transcranial Direct Current Stimulation (tDCS), Sham Stimulation - M1
Participants received Sham stimulation 20 minutes daily for 20 days, and 4 times after continuous stimulation, every 15 days.
|
A stimulation device, that releases 2.0mA current by a 35 cm2 electrode direct located on a specific location on the scalp for 20 minutes
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
level of pain
大体时间：Up to 60 minutes before and after tDCS stimulation
|
response on the Numeric Verbal Scale (NPS) from 0-10 during the conditioning stimulus
|
Up to 60 minutes before and after tDCS stimulation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Psychocognitive functions
大体时间：Pre and Pos 20 days Intervention
|
episodic memory measured by Rey Verbal test
|
Pre and Pos 20 days Intervention
|
|
circadian rhythmicity
大体时间：Pre and Pos 20 days Intervention
|
urinary 6-sulfatoxymelatonin levels
|
Pre and Pos 20 days Intervention
|
|
Effect of tDCS over DLPFC on cognitive function.
大体时间：Pre and Pos 20 days Intervention
|
Cortical connectivity
|
Pre and Pos 20 days Intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Wolnei Caumo, Dr、Hospital de Clinicas de Porto Alegre
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年2月1日
初级完成 (预期的)
2021年12月10日
研究完成 (预期的)
2022年12月10日
研究注册日期
首次提交
2021年2月24日
首先提交符合 QC 标准的
2021年5月12日
首次发布 (实际的)
2021年5月18日
研究记录更新
最后更新发布 (实际的)
2021年5月18日
上次提交的符合 QC 标准的更新
2021年5月12日
最后验证
2021年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.