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

NCT ID: NCT06288984

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-12-31

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.

Conditions

Brain Injuries; Respiratory Function Impaired; Gut Microbiota

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active rTMS

Group Type: EXPERIMENTAL

active rTMS

Intervention Type: DEVICE

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

Group Type: SHAM_COMPARATOR

sham rTMS

Intervention Type: DEVICE

The magnetic stimulation coil was tangent to the scalp and kept perpendicular for 10 minutes a day, 5 days a week for 4 weeks

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jimin Zhang

Role: CONTACT

JiminZhang1@126.com

02061642065

Gang Liu

Role: CONTACT

13580350999@126.com

02061642061

Other Identifiers

NFEC-2024-061

Identifier Type: -

Identifier Source: org_study_id