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Spinal Cord Stimulation and Respiration After Injury

RecruitingNAAges 18 Years - anyAllUniversity of Louisville
NCT05178056 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Respiratory function in patients with chronic spinal cord injury can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. However, the effectiveness of this intervention is limited by the levels of functional capacity preserved below the neurological level of injury. Preliminary data obtained for this study demonstrate that electrical spinal cord stimulation applied epidurally at the lumbar level in combination with respiratory training can activate and re-organize spinal motor networks for respiration. This study is designed to investigate respiratory motor control-related

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📋 Eligibility rules (as published)
Inclusion Criteria: * At least 18 years old * Stable medical condition * Non-progressive C3-T1 AIS A-C Spinal Cord Injury (SCI) * Sustained SCI at least 24 months prior to entering the study * At least 15%-deficit in pulmonary function outcomes Exclusion Criteria: * Painful musculo-skeletal dysfunction * Unhealed fracture * Contracture * Pressure sore * Urinary tract infection that might interfere with respiratory training * Clinically significant depression * Psychiatric disorders * Ongoing drug abuse; * Major cardiovascular disease * Major pulmonary disease * Ventilator dependence * Major endocrine disorders * Malignancy * Marked obesity * Deep vein thrombosis * HIV/AIDS related illness * Secondary causes of respiratory dysfunction * Major gastrointestinal problems * Other major medical illness contraindicated for respiratory training * Pregnantcy
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What it tests

  • Spinal Cord Epidural Stimulation
  • Respiratory Training
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Where

1 site
Frazier Rehabilitation and Neuroscience Institute
Louisville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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