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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: active rTMSExperimental treatment 1 intervention
Group B: sham rTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 0,Week 4
2

Thickening fraction

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

Time frame
Day 0,Week 4

Secondary outcomes

1

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.

Time frame
Day 0,Week 4
2

Surface EMG of diaphragm

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

Time frame
Day 0,Week 4
3

Forced vital capacity(FVC)

The FVC is measured using an Master-Screen spirometer

Time frame
Day 0,Week 4
4

Forced expiratory volume at one second(FEV1)

The FEV1 is measured using an Master-Screen spirometer

Time frame
Day 0,Week 4

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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