Effect of Threshold Pressure-Loaded RMT + tTBS on Respiratory Function in SCI Patients

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries

• Registration Number: NCT07050069
• Lead Sponsor: Shengjing Hospital

Brief 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. 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 Timeline

• Study Start: 2024-12-25
• Status Verified: 2025-06
• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Primary Completion: 2025-12-25
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximal Inspiratory Pressure	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.
Peak Inspiratory Flow	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	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	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.
Maximal Expiratory Pressure	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	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.

Secondary Outcome Measures

Name	Time	Method
Diaphragmatic Thickening Fraction	Week 0 , Week 2 , Week 4	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.
Diaphragmatic Thickness	Week 0 , Week 2 , Week 4	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.
Diaphragmatic Displacement	Week 0 , Week 2 , Week 4	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).

Trial Locations

Locations (1)

Rehabilitation Center of Shengjing Hospital, China Medical University; 🇨🇳 Shenyang, Liaoning, China