Effect of Threshold Pressure-Loaded RMT + tTBS on Respiratory Function in SCI Patients
NCT ID: NCT07050069
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-12-25
2025-12-25
Brief Summary
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* 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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device
Participants received group-specific interventions 5 days/week for 4 weeks.
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.
Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device
Participants received group-specific interventions 5 days/week for 4 weeks.
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.
Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device
Participants received group-specific interventions 5 days/week for 4 weeks.
Interventions
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Transcranial Magnetic Stimulation (TMS) Device / Respiratory Training Device
Participants received group-specific interventions 5 days/week for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Shengjing Hospital
OTHER
Responsible Party
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Xue Jiang
Associate Professor
Principal Investigators
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Jiang Xue
Role: PRINCIPAL_INVESTIGATOR
Rehabilitation Center of Shengjing Hospital, China Medical University
Locations
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Rehabilitation Center of Shengjing Hospital, China Medical University
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024PS1936K
Identifier Type: -
Identifier Source: org_study_id
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