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NCT Number: NCT07050069

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device

Device

Participants received group-specific interventions 5 days/week for 4 weeks.

Primary outcomes

  1. Maximal Inspiratory Pressure

    Time frame: 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.

  2. Maximal Expiratory Pressure

    Time frame: 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.

  3. Peak Expiratory Flow

    Time frame: 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.

  4. Peak Inspiratory Flow

    Time frame: 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.

  5. Forced Expiratory Volume in 1 second

    Time frame: 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.

  6. Forced Vital Capacity

    Time frame: 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.

Secondary outcomes

  1. Diaphragmatic Thickness

    Time frame: 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.

  2. Diaphragmatic Displacement

    Time frame: 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).

  3. Diaphragmatic Thickening Fraction

    Time frame: 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.

Other outcomes

  1. 4th Intercostal Space Thoracic Mobility

    Time frame: Week 0 , Week 2 , Week 4

    At the 4th intercostal space along the midclavicular or anterior axillary line, thoracic mobility is measured by the difference in circumferences between maximal exhalation and inhalation using a non-stretch tape.

  2. Maximum Vowel Prolongation Time

    Time frame: Week 0 , Week 2 , Week 4

    Maximum vowel prolongation time is obtained by measuring the duration of sustained /a:/ phonation from maximal inspiration to complete expiration, with the subject seated upright and maintaining consistent pitch and loudness

  3. The incidence of pneumonia during hospitalization for each patient group

    Time frame: Week 0 , Week 2 , Week 4

    The incidence of pneumonia during hospitalization for each patient group is calculated as the number of newly diagnosed pneumonia cases divided by the total number of patients in the group, typically expressed per 100 patient-days or as a percentage.

  4. Motor Function

    Time frame: Week 0 , Week 2 , Week 4

    Trunk Control Test,Modified Barthel Index

  5. Hemodynamic Changes " BP " During Supine-to-Sitting Transfer

    Time frame: Week 0 , Week 2 , Week 4

    Measure baseline supine BP after 10-min rest.

  6. Hemodynamic Changes "HR" During Supine-to-Sitting Transfer

    Time frame: Week 0 , Week 2 , Week 4

    Measure baseline supine HR after 10-min rest.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiang Xue

CONTACT

[email protected]

+86 18940254064

Zhang Di

CONTACT

[email protected]

+86 15291000208

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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