Improving breathing in spinal cord injury patients using stimulation and training
Epidural Spinal Cord Stimulation and Respiratory Motor Function After Injury
This study is testing if combining spinal cord stimulation with breathing exercises can help improve breathing in patients with spinal cord injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT05178056 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance respiratory function in patients with spinal cord injuries by combining epidural spinal cord stimulation with a respiratory training protocol. The research focuses on understanding how these interventions can activate and reorganize spinal motor networks responsible for respiration. By investigating the effects of spinal cord stimulation alone and in conjunction with respiratory training, the study seeks to develop a new standard of care for respiratory rehabilitation in this population. The ultimate goal is to reduce morbidity and mortality associated with respiratory complications in individuals with chronic spinal cord injuries.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stable, non-progressive spinal cord injuries at the C3-T1 level and a significant pulmonary function deficit.
Not a fit: Patients with major comorbidities such as significant cardiovascular or pulmonary diseases, or those who are ventilator-dependent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve respiratory function and quality of life for patients with spinal cord injuries.
How similar studies have performed: Preliminary data suggest that similar approaches using spinal cord stimulation have shown promise, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Louisville, Kentucky
- Frazier Rehabilitation and Neuroscience Institute — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Alexander Ovechkin, MD, PhD — University of Louisville
- Study coordinator: Alexander Ovechkin, MD, PhD
- Email: avovec02@louisville.edu
- Phone: 5025818675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.