About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
active rTMS
DeviceThe magnetic stimulation coil was tangent to the scalp and kept parallel for 10 minutes a day, 5 days a week for 4 weeks
sham rTMS
DeviceThe magnetic stimulation coil was tangent to the scalp and kept perpendicular for 10 minutes a day, 5 days a week for 4 weeks
Treatment groups
Trial outcomes
Primary outcomes
Diaphragm thickness
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.
Thickening fraction
Thickening fraction = (end-inspiratory diaphragm thickness-end expiratory
Secondary outcomes
Diaphragm mobility
Diaphragm mobility was measured with a 2-5MHz convex array probe, which was located below the costal arch of the midline of the clavicle. The above indexes were measured for 3 consecutive respiratory cycles and averaged.
Surface EMG of diaphragm
The latency period, amplitude and motion threshold were determined by Transcranial magnetic stimulation of motor evoked potential(TMS-MEP).
Forced vital capacity(FVC)
The FVC is measured using an Master-Screen spirometer
Forced expiratory volume at one second(FEV1)
The FEV1 is measured using an Master-Screen spirometer
Locations
Sponsors and contacts
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