Combined threshold pressure respiratory muscle training plus targeted iTBS for improving breathing after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will compare threshold pressure-load respiratory muscle training, intermittent theta-burst stimulation (iTBS) over the diaphragm cortical projection, and the two combined to determine which approach best improves respiratory function in people with spinal cord injury. Participants receive the assigned intervention daily for four weeks and attend hospital visits every two weeks for checks and respiratory testing. Symptoms and objective respiratory measures will be recorded before, during, and after the intervention to track changes. The trial enrolls adults 18–80 with imaging-confirmed SCI at T12 or above, AIS grade A–C, 2 weeks to 6 months post-injury, and excludes those with contraindications to magnetic stimulation or who require mechanical ventilation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rehabilitation Center of Shengjing Hospital, China Medical University
  Shenyang, Liaoning, China Recruiting

Study contacts

• Principal investigator: Jiang Xue — Rehabilitation Center of Shengjing Hospital, China Medical University
• Study coordinator: Jiang Xue
• Email: jiangxueruby@163.com
• Phone: +86 18940254064

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.