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Effects of rTMS on Respiratory Function and Gut Microbiota in Patients With Brain Injury

N

Nanfang Hospital, Southern Medical University

Status

Not yet enrolling

Conditions

Brain Injuries
Respiratory Function Impaired
Gut Microbiota

Treatments

Device: sham rTMS
Device: active rTMS

Study type

Interventional

Funder types

Other

Identifiers

NCT06288984
NFEC-2024-061

Details and patient eligibility

About

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.

Enrollment

74 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

74 participants in 2 patient groups

active rTMS
Experimental group
Treatment:
Device: active rTMS
sham rTMS
Sham Comparator group
Treatment:
Device: sham rTMS

Trial contacts and locations

0

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Central trial contact

Jimin Zhang; Gang Liu

Data sourced from clinicaltrials.gov

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