Spinal Cord InjuriesNCT07050069
Effect of Threshold Pressure-Loaded RMT + tTBS on Respiratory Function in SCI Patients
A study testing Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device in people with Spinal Cord Injuries, run by Shengjing Hospital at 1 site in China.
Trial summary
The purpose of this clinical trial is to understand whether threshold pressure load respiratory muscle training combined with iTBS can effectively improve the respiratory function of SCI patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 25 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with spinal cord injury (SCI) meeting the 2019 revised International Standards for Neurological Classification of Spinal Cord Injury by the American Spinal Injury Association (ASIA), confirmed by CT/MRI.
- Aged 18-80 years.
- Time since injury: 2 weeks to 6 months, with spinal shock resolved.
- Injury level at T12 or above, ASIA Impairment Scale (AIS) grade A-C.
- Patients providing written informed consent after study explanation.
Who cannot join
- Patients with severe cardiorespiratory diseases (e.g., pneumothorax).
- Unstable vital signs (e.g., hypotension, arrhythmia).
- Cognitive/psychiatric disorders precluding cooperation.
- Requiring mechanical ventilation.
- Congenital spinal/limb deformities.
- Contraindications to magnetic stimulation: intracranial metal implants, pacemakers, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Rehabilitation Center of Shengjing Hospital, China Medical University
Shenyang, Liaoning, 110000
Xue Jiang, +86 189 4025 4064, jiangxueruby@163.com
Di Zhang, +86 15291000208, zhangdi6952@163.com
About this study
Official title: The Effect of Threshold Pressure-loaded Respiratory Muscle Training Combined With Transcranial Intermittent Theta Burst Stimulation on Respiratory Function in Patients With Spinal Cord Injury
The purpose of this clinical trial is to understand whether threshold pressure load respiratory muscle training combined with iTBS can effectively improve the respiratory function of SCI patients. The main questions it aims to answer are:
- The impact of threshold pressure load respiratory muscle training on the respiratory function of SCI patients.
- The impact of iTBS treatment at the cortical projection point of the diaphragm on the respiratory function of SCI patients.
- Whether the combination of the above two treatment techniques is superior to single treatment.
Read the detailed description
Researchers will combine threshold pressure load respiratory muscle training and transcranial iTBS and compare them with single treatments to see if the combined treatment is superior to single treatment.
Participants will:
- Undergo threshold pressure load respiratory muscle training or transcranial iTBS treatment or a combination of both daily for 4 weeks.
- Visit the hospital for check-ups and tests every 2 weeks.
- Record their symptoms and respiratory function.
- Conditions
- Spinal Cord Injuries
- Being tested
- Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training DeviceDevice
Participants received group-specific interventions 5 days/week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A: sham stimulation + threshold pressure-loaded respiratory muscle training | Experimental | Sham Stimulation "8" coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT intensity. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess. Coil at 90° to scalp to avoid cortical current.
Threshold Pressure-Loaded RMT Saike trainer used. Pt. seated/reclined, nasal clips occluding nares. Filter mouthpiece connected to valve; tight oral seal. Resistance: 30% of MIP/MEP. 10 min inhale/exhale each, 20 min/d. Weekly MIP/MEP reassessment to adjust resistance. 4 wk, 5 d/wk. Receives: Device: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device |
| Group B: iTBS + traditional respiratory training | Experimental | iTBS Therapy 8-shape coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess.
Traditional Respiratory Training 5 therapist-led maneuvers: Pursed-lip: inhale (3-4s) via nose, pause (1-2s), exhale (5-6s) with pursed lips (6-8 br/min), 20 br/set.
Diaphragmatic: seated/supine, hands over umbilicus. Inhale to expand abdomen (3-5s), exhale to compress (6-8s). 4-6 br/min, 20 br/set.
Forced exhale: inhale (3-5s), forcefully exhale "ha" (2-3s), 4-6 br/min, 20 br/set.
Resisted inhale: supine, 1kg sandbag on umbilicus. Diaphragmatic breathing (4-6 br/min), 20 br/set.
3 sets/d, 5d/wk × 4wk. Receives: Device: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device |
| Group C: iTBS + threshold pressure-loaded respiratory muscle training | Experimental | iTBS Therapy 8-shape coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess.
Threshold Pressure-Loaded RMT Saike trainer used. Pt. seated/reclined, nasal clips occluding nares. Filter mouthpiece connected to valve; tight oral seal. Resistance: 30% of MIP/MEP. 10 min inhale/exhale each, 20 min/d. Weekly MIP/MEP reassessment to adjust resistance. 4 wk, 5 d/wk. Receives: Device: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure
the maximum negative pressure generated in the respiratory system during a maximal inhalation against a closed airway, measured in cmH₂O to assess inspiratory muscle strength.
Measured: Week 0 , Week 2 , Week 4
Maximal Expiratory Pressure
the maximum positive pressure generated in the respiratory system during a maximal exhalation against a closed airway, measured in cmH₂O to assess expiratory muscle strength.
Measured: Week 0 , Week 2 , Week 4
Peak Expiratory Flow
the maximum speed of air flow during a forced exhalation, measured in liters per minute (L/min) to assess airway patency and respiratory function.
Measured: Week 0 , Week 2 , Week 4
Peak Inspiratory Flow
the maximum speed of air flow during a forced inhalation, measured in liters per minute (L/min) to evaluate inspiratory muscle function and airway resistance during inhalation.
Measured: Week 0 , Week 2 , Week 4
Forced Expiratory Volume in 1 second
the volume of air exhaled forcefully within the first second of a maximal expiratory effort, measured in liters to assess airway obstruction and lung function.
Measured: Week 0 , Week 2 , Week 4
Forced Vital Capacity
the total volume of air exhaled forcefully and completely after a maximal inhalation, measured in liters to evaluate lung function and airway patency.
Measured: Week 0 , Week 2 , Week 4
Secondary outcomes (3)
Diaphragmatic Thickness
Position patient supine with arms up. Place convex probe at mid-axillary line (7th-9th intercostal space), parasagittal plane.
Identify diaphragmatic muscle between pleural and peritoneal interfaces, 2-3 cm from central tendon.
Measure thickness at end-expiration and end-inspiration (3 trials each). Calculate DTF to assess diaphragmatic function.
Measured: Week 0 , Week 2 , Week 4
Diaphragmatic Displacement
Position patient supine/semi-recumbent, expose lower chest. Place convex probe at mid-axillary line (8th-10th intercostal space), sagittal plane.
Visualize diaphragmatic-liver interface (right hemidiaphragm preferred). Use M-mode to record diaphragmatic movement over respiratory cycles. Measure vertical distance between end-expiration and end-inspiration positions (normal >1.5 cm for weaning).
Measured: Week 0 , Week 2 , Week 4
Diaphragmatic Thickening Fraction
Measure Thickness at End-Expiration:
Using ultrasound, measure the diaphragm thickness at the end of a quiet exhalation (when the diaphragm is relaxed).
Measure Thickness at End-Inspiration:
Measure the thickness at the end of a maximal inhalation (when the diaphragm is fully contracted).
Calculate the Difference:
Subtract the end-expiration thickness from the end-inspiration thickness.
Normalize by End-Expiration Thickness:
Divide the difference by the end-expiration thickness, then multiply by 100 to get a percentage.
Measured: Week 0 , Week 2 , Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start25 Dec 2024
- Primary completion25 Dec 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- Model description
- Group A: sham stimulation + threshold pressure-loaded respiratory muscle training; Group B: iTBS + traditional respiratory training; Group C: iTBS + threshold pressure-loaded respiratory muscle training.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Jiang, Shengjing Hospital
- Investigators
- Jiang Xue, Principal investigator, Rehabilitation Center of Shengjing Hospital, China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050069
- Sponsor's protocol ID
- 2024PS1936K
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 3 Jul 2025
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Threshold Pressure-loaded Respiratory Muscle Training Combined With Transcranial Intermittent Theta Burst Stimulation on Respiratory Function in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07050069
- Acronym / sponsor ID
- 2024PS1936K
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 3 Jul 2025 (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.
The purpose of this clinical trial is to understand whether threshold pressure load respiratory muscle training combined with iTBS can effectively improve the respiratory function of SCI patients. The main questions it aims to answer are:
- The impact of threshold pressure load respiratory muscle training on the respiratory function of SCI patients.
- The impact of iTBS treatment at the cortical projection point of the diaphragm on the respiratory function of SCI patients.
- Whether the combination of the above two treatment techniques is superior to single treatment.
Detailed description
Researchers will combine threshold pressure load respiratory muscle training and transcranial iTBS and compare them with single treatments to see if the combined treatment is superior to single treatment.
Participants will:
- Undergo threshold pressure load respiratory muscle training or transcranial iTBS treatment or a combination of both daily for 4 weeks.
- Visit the hospital for check-ups and tests every 2 weeks.
- Record their symptoms and respiratory function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Group A: sham stimulation + threshold pressure-loaded respiratory muscle training; Group B: iTBS + traditional respiratory training; Group C: iTBS + threshold pressure-loaded respiratory muscle training.
| Arm | Type | Receives |
|---|---|---|
| Group A: sham stimulation + threshold pressure-loaded respiratory muscle training | Experimental | Device: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training DeviceSham Stimulation "8" coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT intensity. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess. Coil at 90° to scalp to avoid cortical current. Threshold Pressure-Loaded RMT Saike trainer used. Pt. seated/reclined, nasal clips occluding nares. Filter mouthpiece connected to valve; tight oral seal. Resistance: 30% of MIP/MEP. 10 min inhale/exhale each, 20 min/d. Weekly MIP/MEP reassessment to adjust resistance. 4 wk, 5 d/wk. |
| Group B: iTBS + traditional respiratory training | Experimental | Device: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training DeviceiTBS Therapy 8-shape coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess. Traditional Respiratory Training 5 therapist-led maneuvers: Pursed-lip: inhale (3-4s) via nose, pause (1-2s), exhale (5-6s) with pursed lips (6-8 br/min), 20 br/set. Diaphragmatic: seated/supine, hands over umbilicus. Inhale to expand abdomen (3-5s), exhale to compress (6-8s). 4-6 br/min, 20 br/set. Forced exhale: inhale (3-5s), forcefully exhale "ha" (2-3s), 4-6 br/min, 20 br/set. Resisted inhale: supine, 1kg sandbag on umbilicus. Diaphragmatic breathing (4-6 br/min), 20 br/set. 3 sets/d, 5d/wk × 4wk. |
| Group C: iTBS + threshold pressure-loaded respiratory muscle training | Experimental | Device: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training DeviceiTBS Therapy 8-shape coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess. Threshold Pressure-Loaded RMT Saike trainer used. Pt. seated/reclined, nasal clips occluding nares. Filter mouthpiece connected to valve; tight oral seal. Resistance: 30% of MIP/MEP. 10 min inhale/exhale each, 20 min/d. Weekly MIP/MEP reassessment to adjust resistance. 4 wk, 5 d/wk. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with spinal cord injury (SCI) meeting the 2019 revised International Standards for Neurological Classification of Spinal Cord Injury by the American Spinal Injury Association (ASIA), confirmed by CT/MRI.
- Aged 18-80 years.
- Time since injury: 2 weeks to 6 months, with spinal shock resolved.
- Injury level at T12 or above, ASIA Impairment Scale (AIS) grade A-C.
- Patients providing written informed consent after study explanation.
Key exclusion criteria (6 listed)
- Patients with severe cardiorespiratory diseases (e.g., pneumothorax).
- Unstable vital signs (e.g., hypotension, arrhythmia).
- Cognitive/psychiatric disorders precluding cooperation.
- Requiring mechanical ventilation.
- Congenital spinal/limb deformities.
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training DeviceParticipants received group-specific interventions 5 days/week for 4 weeks. | Device | Group A: sham stimulation + threshold pressure-loaded respiratory muscle training, Group B: iTBS + traditional respiratory training, Group C: iTBS + threshold pressure-loaded respiratory muscle training |
Primary outcome
Maximal Inspiratory Pressure
Time frame: Week 0 , Week 2 , Week 4
the maximum negative pressure generated in the respiratory system during a maximal inhalation against a closed airway, measured in cmH₂O to assess inspiratory muscle strength.
Maximal Expiratory Pressure
Time frame: Week 0 , Week 2 , Week 4
the maximum positive pressure generated in the respiratory system during a maximal exhalation against a closed airway, measured in cmH₂O to assess expiratory muscle strength.
Peak Expiratory Flow
Time frame: Week 0 , Week 2 , Week 4
the maximum speed of air flow during a forced exhalation, measured in liters per minute (L/min) to assess airway patency and respiratory function.
Peak Inspiratory Flow
Time frame: Week 0 , Week 2 , Week 4
the maximum speed of air flow during a forced inhalation, measured in liters per minute (L/min) to evaluate inspiratory muscle function and airway resistance during inhalation.
Forced Expiratory Volume in 1 second
Time frame: Week 0 , Week 2 , Week 4
the volume of air exhaled forcefully within the first second of a maximal expiratory effort, measured in liters to assess airway obstruction and lung function.
Forced Vital Capacity
Time frame: Week 0 , Week 2 , Week 4
the total volume of air exhaled forcefully and completely after a maximal inhalation, measured in liters to evaluate lung function and airway patency.
3 secondary outcomes
Diaphragmatic Thickness
Time frame: Week 0 , Week 2 , Week 4
Diaphragmatic Displacement
Time frame: Week 0 , Week 2 , Week 4
Diaphragmatic Thickening Fraction
Time frame: Week 0 , Week 2 , 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 3 Jul 2025.
- 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.
Jiang Xue principal investigator
Rehabilitation Center of Shengjing Hospital, China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device in people with Spinal Cord Injuries, run by Shengjing Hospital at 1 site in China.
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 6 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Jiang Xue (+86 18940254064, jiangxueruby@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (time frame: Week 0 , Week 2 , Week 4). The study lists 6 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 3 Jul 2025.