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NCT Number: NCT06288984

Effects of 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.

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Gut Microbiota Nervous System Diseases Respiration Disorders Respiratory Function Impaired Respiratory Insufficiency Respiratory Tract Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Diaphragm thickness

    Time frame: Day 0，Week 4

    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.

  2. Thickening fraction

    Time frame: Day 0，Week 4

    Thickening fraction = (end-inspiratory diaphragm thickness-end expiratory

Secondary outcomes

  1. Diaphragm mobility

    Time frame: Day 0，Week 4

    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.

  2. Surface EMG of diaphragm

    Time frame: Day 0，Week 4

    The latency period, amplitude and motion threshold were determined by Transcranial magnetic stimulation of motor evoked potential(TMS-MEP).

  3. Forced vital capacity(FVC)

    Time frame: Day 0，Week 4

    The FVC is measured using an Master-Screen spirometer

  4. Forced expiratory volume at one second（FEV1）

    Time frame: Day 0，Week 4

    The FEV1 is measured using an Master-Screen spirometer

  5. Peak expiratory flow (PEF)

    Time frame: Day 0，Week 4

    The PEF is measured using an Master-Screen spirometer

  6. Maximum voluntary ventilation (MVV)

    Time frame: Day 0，Week 4

    The MVV is measured using an Master-Screen spirometer

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Liu

CONTACT

[email protected]

02061642061

Jimin Zhang

CONTACT

[email protected]

02061642065

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 1, 2024
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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