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Search / Trial NCT07050069

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

Launched by SHENGJING HOSPITAL · Jul 2, 2025

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether a special type of breathing exercise, called threshold pressure-loaded respiratory muscle training, combined with a brain stimulation technique known as intermittent theta burst stimulation (iTBS), can help improve breathing in people who have spinal cord injuries. The researchers want to find out if each treatment helps on its own and if using both together works better than just one.

People who may join the study are adults between 18 and 80 years old who have had a spinal cord injury within the past 2 weeks to 6 months. Their injury must be confirmed by scans and affect the area at or above the lower back (T12 or higher). They also need to be stable, able to follow instructions, and not require a breathing machine. Participants will be asked to give written consent after learning about the study. The goal is to see if these treatments can help improve lung function and make breathing easier for people after spinal cord injury.

Gender

ALL

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.

About Shengjing Hospital

Shengjing Hospital, affiliated with the China Medical University, is a leading medical institution dedicated to advancing healthcare through innovative clinical research and trials. With a strong emphasis on multidisciplinary collaboration, the hospital leverages its state-of-the-art facilities and a team of experienced healthcare professionals to conduct comprehensive studies aimed at improving patient outcomes. Shengjing Hospital is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring that all clinical trials are designed to enhance medical knowledge and provide safe, effective treatment options for diverse patient populations.

Locations

Shenyang, Liaoning, China

Patients applied

0 patients applied

Trial Officials

Jiang Xue

Principal Investigator

Rehabilitation Center of Shengjing Hospital, China Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported