Clinical trial NCT06288984: Effects of rTMS on Respiratory Function and Gut Microbiota in Patients With Brain Injury
Official title: Effects of Repetitive Transcranial Magnetic Stimulation(rTMS) on Respiratory Function and Gut Microbiota in Patients With Brain Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Injuries
Respiratory Function Impaired
Gut Microbiota
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Epilepsy
* Metal implant
* Patients who were judged by the investigator to be unsuitable for participation in this trial

Primary outcomes:
measure: Diaphragm thickness
timeFrame: Day 0，Week 4
measure: Thickening fraction
timeFrame: Day 0，Week 4
Secondary outcomes:
measure: Diaphragm mobility
timeFrame: Day 0，Week 4
measure: Surface EMG of diaphragm
timeFrame: Day 0，Week 4
measure: Forced vital capacity(FVC)
timeFrame: Day 0，Week 4
measure: Forced expiratory volume at one second（FEV1）
timeFrame: Day 0，Week 4
measure: Peak expiratory flow (PEF)
timeFrame: Day 0，Week 4
measure: Maximum voluntary ventilation (MVV)
timeFrame: Day 0，Week 4
Other outcomes:
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Study officials:
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