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

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

This will test whether daily breathing muscle training combined with targeted intermittent theta-burst stimulation (iTBS) helps people with recent spinal cord injuries breathe better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shengjing Hospital (other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT07050069 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–80 with a confirmed spinal cord injury at T12 or above, AIS grade A–C, 2 weeks to 6 months after injury, who can give informed consent are the intended participants.

Not a fit: Patients who are ventilator-dependent, have unstable vital signs, severe cardiorespiratory disease, or contraindications to magnetic stimulation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combined treatment could strengthen breathing muscles and reduce respiratory complications for people with recent spinal cord injuries.

How similar studies have performed: Respiratory muscle training and noninvasive brain stimulation have shown promise individually in prior work, but combining threshold-load training with targeted iTBS for diaphragm function is relatively novel and not yet well established.

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.

Where this trial is running

Shenyang, Liaoning

• 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

Conditions: Spinal Cord Injuries