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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Injuries; Gut Microbiota; Respiratory Function Impaired
• Intervention / Treatment: Device: active rTMS; Device: sham rTMS

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jimin Zhang; Phone Number: 02061642065; Email: JiminZhang1@126.com
• Study Contact Backup: Name: Gang Liu; Phone Number: 02061642061; Email: 13580350999@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active rTMS	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 Comparator: sham rTMS	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Thickening fraction	Thickening fraction = (end-inspiratory diaphragm thickness-end expiratory	Day 0，Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Forced vital capacity(FVC)	The FVC is measured using an Master-Screen spirometer	Day 0，Week 4
Forced expiratory volume at one second（FEV1）	The FEV1 is measured using an Master-Screen spirometer	Day 0，Week 4
Peak expiratory flow (PEF)	The PEF is measured using an Master-Screen spirometer	Day 0，Week 4
Maximum voluntary ventilation (MVV)	The MVV is measured using an Master-Screen spirometer	Day 0，Week 4

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 17, 2024
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Estimated): March 1, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Respiratory Insufficiency; Wounds and Injuries
• Other Study ID Numbers: NFEC-2024-061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No