Effect of Threshold Pressure-Loaded RMT + tTBS on Respiratory Function in SCI Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device
Participants received group-specific interventions 5 days/week for 4 weeks.
Primary outcome measures
- Maximal Inspiratory Pressure [Time frame: Week 0 , Week 2 , Week 4]
- Maximal Expiratory Pressure [Time frame: Week 0 , Week 2 , Week 4]
- Peak Expiratory Flow [Time frame: Week 0 , Week 2 , Week 4]
- Peak Inspiratory Flow [Time frame: Week 0 , Week 2 , Week 4]
- Forced Expiratory Volume in 1 second [Time frame: Week 0 , Week 2 , Week 4]
- Forced Vital Capacity [Time frame: Week 0 , Week 2 , Week 4]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Rehabilitation Center of Shengjing Hospital, China Medical University — Shenyang
Identifiers
NCT: NCT07050069 · 2024PS1936K