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

Brain Injuries Clinical Trial

Official title:

Effects of Repetitive Transcranial Magnetic Stimulation(rTMS) on Respiratory Function and Gut Microbiota in Patients With Brain Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06288984
• Other study ID #: NFEC-2024-061
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Gut Microbiota
• Respiratory Function Impaired
• Respiratory Insufficiency
• Wounds and Injuries

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