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

NCT07050069 | Recruiting

• 1 other identifier: 2024PS1936K
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (6)

• Maximal Inspiratory Pressure

  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.

  Week 0 , Week 2 , Week 4

• Maximal Expiratory Pressure

  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.

  Week 0 , Week 2 , Week 4

• Peak Expiratory Flow

  the maximum speed of air flow during a forced exhalation, measured in liters per minute (L/min) to assess airway patency and respiratory function.

  Week 0 , Week 2 , Week 4

• Peak Inspiratory Flow

  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.

  Week 0 , Week 2 , Week 4

• Forced Expiratory Volume in 1 second

  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.

  Week 0 , Week 2 , Week 4

• Forced Vital Capacity

  the total volume of air exhaled forcefully and completely after a maximal inhalation, measured in liters to evaluate lung function and airway patency.

  Week 0 , Week 2 , Week 4

Secondary Outcomes (3)

• Diaphragmatic Thickness

  Week 0 , Week 2 , Week 4

• Diaphragmatic Displacement

  Week 0 , Week 2 , Week 4

• Diaphragmatic Thickening Fraction

  Week 0 , Week 2 , Week 4

Other Outcomes (6)

• 4th Intercostal Space Thoracic Mobility

  Week 0 , Week 2 , Week 4

• Maximum Vowel Prolongation Time

  Week 0 , Week 2 , Week 4

• The incidence of pneumonia during hospitalization for each patient group

  Week 0 , Week 2 , Week 4

Study Arms (3)

Group A: sham stimulation + threshold pressure-loaded respiratory muscle training

EXPERIMENTAL

Sham Stimulation "8" coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT intensity. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess. Coil at 90° to scalp to avoid cortical current. Threshold Pressure-Loaded RMT Saike trainer used. Pt. seated/reclined, nasal clips occluding nares. Filter mouthpiece connected to valve; tight oral seal. Resistance: 30% of MIP/MEP. 10 min inhale/exhale each, 20 min/d. Weekly MIP/MEP reassessment to adjust resistance. 4 wk, 5 d/wk.

Device: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device

Group B: iTBS + traditional respiratory training

EXPERIMENTAL

iTBS Therapy 8-shape coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess. Traditional Respiratory Training 5 therapist-led maneuvers: Pursed-lip: inhale (3-4s) via nose, pause (1-2s), exhale (5-6s) with pursed lips (6-8 br/min), 20 br/set. Diaphragmatic: seated/supine, hands over umbilicus. Inhale to expand abdomen (3-5s), exhale to compress (6-8s). 4-6 br/min, 20 br/set. Forced exhale: inhale (3-5s), forcefully exhale "ha" (2-3s), 4-6 br/min, 20 br/set. Resisted inhale: supine, 1kg sandbag on umbilicus. Diaphragmatic breathing (4-6 br/min), 20 br/set. 3 sets/d, 5d/wk × 4wk.

Device: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device

Group C: iTBS + threshold pressure-loaded respiratory muscle training

EXPERIMENTAL

iTBS Therapy 8-shape coil at bilateral diaphragmatic cortical projections (2-3 cm ant. to coronal line, 3 cm lat. to midline). 80% MT. Each pulse train: 3 bursts (50 Hz intra/5 Hz inter), 2s on/8s off. Total 1,200 pulses (600/side), 5 sess/wk × 20 sess. Threshold Pressure-Loaded RMT Saike trainer used. Pt. seated/reclined, nasal clips occluding nares. Filter mouthpiece connected to valve; tight oral seal. Resistance: 30% of MIP/MEP. 10 min inhale/exhale each, 20 min/d. Weekly MIP/MEP reassessment to adjust resistance. 4 wk, 5 d/wk.

Device: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device

Interventions

Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device DEVICE

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

Group A: sham stimulation + threshold pressure-loaded respiratory muscle training; Group B: iTBS + traditional respiratory training; Group C: iTBS + threshold pressure-loaded respiratory muscle training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Rehabilitation Center of Shengjing Hospital, China Medical University

Shenyang, Liaoning, 110000, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Jiang Xue

  Rehabilitation Center of Shengjing Hospital, China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Xue

CONTACT

+86 18940254064; jiangxueruby@163.com

Zhang Di

CONTACT

+86 15291000208; zhangdi6952@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Group A: sham stimulation + threshold pressure-loaded respiratory muscle training; Group B: iTBS + traditional respiratory training; Group C: iTBS + threshold pressure-loaded respiratory muscle training.

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 3, 2025
• Study Start: December 25, 2024
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)