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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06288984
Other study ID # NFEC-2024-061
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2026

Study information

Verified date February 2024
Source Nanfang Hospital, Southern Medical University
Contact Jimin Zhang
Phone 02061642065
Email JiminZhang1@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 74
Est. completion date December 31, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

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
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital, Southern Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 0,Week 4
Primary Thickening fraction Thickening fraction = (end-inspiratory diaphragm thickness-end expiratory Day 0,Week 4
Secondary 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. Day 0,Week 4
Secondary Surface EMG of diaphragm The latency period, amplitude and motion threshold were determined by Transcranial magnetic stimulation of motor evoked potential(TMS-MEP). Day 0,Week 4
Secondary Forced vital capacity(FVC) The FVC is measured using an Master-Screen spirometer Day 0,Week 4
Secondary Forced expiratory volume at one second(FEV1) The FEV1 is measured using an Master-Screen spirometer Day 0,Week 4
Secondary Peak expiratory flow (PEF) The PEF is measured using an Master-Screen spirometer Day 0,Week 4
Secondary Maximum voluntary ventilation (MVV) The MVV is measured using an Master-Screen spirometer Day 0,Week 4
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