Clinical and Hemodynamic Correlates of Different Polarities of High-definition Transcranial Direct Current Stimulation in Chronic Respiratory Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in cerebral hemodynamic response
研究概览
简要总结
The aim of this pilot randomized clinical trial is to identify the acute effects of HD-tDCS in the diaphragm cortex on cerebral hemodynamics in individuals with COPD.
The main questions to answer are:
Is there a change in cortical metabolism (HbO and OXYHb consumption) during and immediately after the application of HD-tDCS? Are there any particularities in cortical hemodynamics between the different HD-tDCS polarities? Participants will perform three HD-tDCS sessions, each one with a different type of stimulation (anodal, cathodal and sham) lasting for 20 minutes. Before, during and after stimulation, near-infrared spectrography will be used as assessment instruments.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old;
- •Airflow limitation mild to severe (GOLD 1-3);
- •No contraindications for HD-tDCS, such as pregnancy, metal implants in the head, cochlear implants and pacemaker;
- •Absence of concomitant diseases of the central or peripheral nervous system.
排除标准
- •Refusal to sign the TCLE;
- •Missing two consecutive or three alternate sessions during treatment;
- •Develop any disabling condition that prevents continued participation in the study.
研究组 & 干预措施
anodal stimulation
Stimulation will be carried out in the diaphragm cortex with anodal current for 20 minutes. Before, during and after evaluation will be carried out with near infrared spectroscopy.
干预措施: High-definition Transcranial Direct Current Stimulation (Device)
cathodal stimulation
Stimulation will be carried out in the diaphragm cortex with cathodal current for 20 minutes. Before, during and after evaluation will be carried out with near infrared spectroscopy.
干预措施: High-definition Transcranial Direct Current Stimulation (Device)
sham stimulation
Placebo stimulation will be carried out in the diaphragm cortex for 20 minutes. Before, during and after evaluation will be carried out with near infrared spectroscopy.
干预措施: Sham High-definition Transcranial Direct Current Stimulation (Other)
结局指标
主要结局
Change in cerebral hemodynamic response
时间窗: Before, during, and after each 20-minute HD-tDCS session
Change in oxygenated (OxyHb) and deoxygenated (DeoxyHb) hemoglobin concentration measured by functional near-infrared spectroscopy (fNIRS)
次要结局
- respiratory muscle strength(Immediately before and immediately after the intervention)
研究者
Suellen Andrade
Principal Investigator
Federal University of Paraíba