Brain InjuriesNCT06288984
Effects of rTMS on Respiratory Function and Gut Microbiota in Patients With Brain Injury
A study testing active rTMS in people with Brain Injuries and Respiratory Function Impaired, run by Nanfang Hospital, Southern Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain Injuries, Respiratory Function Impaired, Gut Microbiota
- What is being tested?
- active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Epilepsy
- Metal implant
- Patients who were judged by the investigator to be unsuitable for participation in this trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- active rTMS, sham rTMS
- Medical subject headings
- Brain Injuries, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMSDevice
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 rTMSDevice
The magnetic stimulation coil was tangent to the scalp and kept perpendicular for 10 minutes a day, 5 days a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Experimental | Not described Receives: Device: active rTMS |
| sham rTMS | Sham comparator | Not described Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0，Week 4
Thickening fraction
Thickening fraction = (end-inspiratory diaphragm thickness-end expiratory
Measured: Day 0，Week 4
Secondary outcomes (6)
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.
Measured: 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).
Measured: Day 0，Week 4
Forced vital capacity(FVC)
The FVC is measured using an Master-Screen spirometer
Measured: Day 0，Week 4
Forced expiratory volume at one second（FEV1）
The FEV1 is measured using an Master-Screen spirometer
Measured: Day 0，Week 4
Peak expiratory flow (PEF)
The PEF is measured using an Master-Screen spirometer
Measured: Day 0，Week 4
Maximum voluntary ventilation (MVV)
The MVV is measured using an Master-Screen spirometer
Measured: Day 0，Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288984
- Sponsor's protocol ID
- NFEC-2024-061
- Status last verified
- Feb 2024
- First submitted
- 17 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Transcranial Magnetic Stimulation(rTMS) on Respiratory Function and Gut Microbiota in Patients With Brain Injury
- ClinicalTrials.gov ID
- NCT06288984
- Acronym / sponsor ID
- NFEC-2024-061
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Experimental | Device: active rTMS |
| sham rTMS | Sham comparator | Device: sham rTMS |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active rTMSThe magnetic stimulation coil was tangent to the scalp and kept parallel for 10 minutes a day, 5 days a week for 4 weeks | Device | active rTMS |
| sham rTMSThe magnetic stimulation coil was tangent to the scalp and kept perpendicular for 10 minutes a day, 5 days a week for 4 weeks | Device | sham rTMS |
Primary outcome
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.
Thickening fraction
Time frame: Day 0，Week 4
Thickening fraction = (end-inspiratory diaphragm thickness-end expiratory
6 secondary outcomes
Diaphragm mobility
Time frame: Day 0，Week 4
Surface EMG of diaphragm
Time frame: Day 0，Week 4
Forced vital capacity(FVC)
Time frame: Day 0，Week 4
Forced expiratory volume at one second（FEV1）
Time frame: Day 0，Week 4
Peak expiratory flow (PEF)
Time frame: Day 0，Week 4
Maximum voluntary ventilation (MVV)
Time frame: Day 0，Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing active rTMS in people with Brain Injuries and Respiratory Function Impaired, run by Nanfang Hospital, Southern Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jimin Zhang (02061642065, JiminZhang1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm thickness (time frame: Day 0，Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.