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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximal Inspiratory Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group B: iTBS + traditional respiratory training
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.
干预措施: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device (Device)
Group C: iTBS + threshold pressure-loaded respiratory muscle training
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.
干预措施: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device (Device)
Group A: sham stimulation + threshold pressure-loaded respiratory muscle training
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.
干预措施: Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device (Device)
结局指标
主要结局
Maximal Inspiratory Pressure
时间窗: 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.
Peak Inspiratory Flow
时间窗: 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.
Forced Expiratory Volume in 1 second
时间窗: 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.
Forced Vital Capacity
时间窗: 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.
Maximal Expiratory Pressure
时间窗: 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.
Peak Expiratory Flow
时间窗: 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.
次要结局
- Diaphragmatic Thickening Fraction(Week 0 , Week 2 , Week 4)
- Diaphragmatic Thickness(Week 0 , Week 2 , Week 4)
- Diaphragmatic Displacement(Week 0 , Week 2 , Week 4)
研究者
Xue Jiang
Associate Professor
Shengjing Hospital