Effects of Repetitive Transcranial Magnetic Stimulation(rTMS) on Respiratory Function and Gut Microbiota in Patients With Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 主要终点
- Thickening fraction
研究概览
简要总结
Impaired respiratory function may occur after brain injury, and will progress to restricted respiratory dysfunction without early intervention. At present, there is a lack of effective treatment options for respiratory dysfunction. Repetitive Transcranial Magnetic Stimulation(rTMS) is a non-invasive, painless and non-invasive neuroregulatory technique. In healthy people, rTMS applied to the respiratory motor cortex induces a contralateral respiratory muscle response. However, whether rTMS can improve respiratory function in patients with brain injury remains unclear. gut microbiota can affect muscle function and mass, and animal experiments have shown that probiotics can increase skeletal muscle mass and grip strength in mice. On the other hand, studies have found that rTMS can improve the nutritional status of patients with vegetative state by regulating the structure of gut microbiota. However, it remains unclear whether rTMS can improve respiratory muscle function in patients with brain injury by regulating gut microbiota. Therefore, the investigators intend to apply rTMS to the respiratory motor cortex to observe whether rTMS can improve respiratory function and reduce the incidence of pneumonia in patients with brain injury, and to observe the role of gut microbiota in this process.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In line with the diagnostic criteria of "Chinese classification of cerebrovascular diseases(2015)" mRS Score 2-4 points or craniocerebral injury caused by trauma, GCS score > 8 points
- •Between 18 and 70 years old
- •The first incidence of cerebrovascular disease or traumatic brain injury, and the course of disease was 10-180 days
- •Vital signs are stable, no progression
- •Voluntary participation with informed consent
排除标准
- •Patients with a history of respiratory disease, including chronic bronchitis, chronic obstructive pulmonary disease, bronchiectasis, and lung cancer
- •Severe bone malformations in the chest or spine
- •Have other neurological or neuromuscular disorders
- •History of thoracic and abdominal surgery
- •Severe heart, lung, kidney, liver or other organ dysfunction
- •Pregnant and lactating women
- •Metal implant
- •Patients who were judged by the investigator to be unsuitable for participation in this trial
结局指标
主要结局
Thickening fraction
时间窗: Day 0，Week 4
Thickening fraction = (end-inspiratory diaphragm thickness-end expiratory
Diaphragm thickness
时间窗: Day 0，Week 4
Diaphragm thickness was measured using a 10-15 MHz linear array probe, and the probe was positioned in the 8th to 11th costal space between the midaxillary line or anterior axillary line, perpendicular to the skin at the end of inspiratory phase and the end of expiratory phase.
次要结局
- Maximum voluntary ventilation (MVV)(Day 0，Week 4)
- Forced expiratory volume at one second（FEV1）(Day 0，Week 4)
- Forced vital capacity(FVC)(Day 0，Week 4)
- Diaphragm mobility(Day 0，Week 4)
- Surface EMG of diaphragm(Day 0，Week 4)
- Peak expiratory flow (PEF)(Day 0，Week 4)