Effects of rTMS on Respiratory Function and Gut Microbiota in Patients With Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: active rTMS, sham rTMS.
- Who it may be relevant to
- Registry conditions: Brain Injuries, Respiratory Function Impaired, Gut Microbiota. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Repetitive Transcranial Magnetic Stimulation(rTMS) on Respiratory Function and Gut Microbiota in Patients With Brain Injury
Overview
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.
Interventions
- Device active rTMS
The magnetic stimulation coil was tangent to the scalp and kept parallel for 10 minutes a day, 5 days a week for 4 weeks - Device sham rTMS
The magnetic stimulation coil was tangent to the scalp and kept perpendicular for 10 minutes a day, 5 days a week for 4 weeks
Primary outcome measures
- Diaphragm thickness [Time frame: Day 0，Week 4]
- Thickening fraction [Time frame: Day 0，Week 4]
Secondary outcome measures (6)
- Diaphragm mobility [Time frame: Day 0，Week 4]
- Surface EMG of diaphragm [Time frame: Day 0，Week 4]
- Forced vital capacity(FVC) [Time frame: Day 0，Week 4]
- Forced expiratory volume at one second（FEV1） [Time frame: Day 0，Week 4]
- Peak expiratory flow (PEF) [Time frame: Day 0，Week 4]
- Maximum voluntary ventilation (MVV) [Time frame: Day 0，Week 4]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06288984 · NFEC-2024-061