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

NCT06288984 | Not Yet Recruiting

• 1 other identifier: NFEC-2024-061
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Diaphragm mobility

  Day 0，Week 4

• Surface EMG of diaphragm

  Day 0，Week 4

• Forced vital capacity(FVC)

  Day 0，Week 4

• Forced expiratory volume at one second（FEV1）

  Day 0，Week 4

• Peak expiratory flow (PEF)

  Day 0，Week 4

Study Arms (2)

active rTMS

EXPERIMENTAL

Device: active rTMS

sham rTMS

SHAM COMPARATOR

Device: sham rTMS

Interventions

active rTMS 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

active rTMS

sham rTMS 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

sham rTMS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Brain Injuries; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Jimin Zhang

CONTACT

02061642065; JiminZhang1@126.com

Gang Liu

CONTACT

02061642061; 13580350999@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: March 1, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share