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

China Medical University

Status: Enrolling

Conditions: Spinal Cord Injuries

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07050069

2024PS1936K

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

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

Experimental group

Description:

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.

Treatment:

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

Group B: iTBS + traditional respiratory training

Experimental group

Description:

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.

Treatment:

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

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

Experimental group

Description:

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.

Treatment:

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