Improving breathing in patients with cervical spinal cord injuries using neuromodulation
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
This study is testing if a special device can help people with cervical spinal cord injuries breathe better and reduce their reliance on ventilators.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT04883463 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and feasibility of implanting a cervical spinal cord stimulator in individuals with cervical spinal cord injuries who are dependent on mechanical ventilation. The research involves multiple phases, including baseline testing, temporary and permanent implant procedures, and post-implant treatment. Participants will undergo laboratory testing and home training sessions to assess their respiratory function and response to the treatment. The study aims to identify the most responsive subjects who could benefit from this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-75 with a cervical spinal cord injury at the C2-C7 level, who are at least one year post-injury and have significant respiratory function compromise.
Not a fit: Patients with severe autonomic dysreflexia or those who have a phrenic nerve or diaphragm pacer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance respiratory function and reduce reliance on mechanical ventilation for patients with cervical spinal cord injuries.
How similar studies have performed: While this approach is innovative, similar studies in neuromodulation for respiratory function have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female 18-75 years 2. At least 1 year from initial cervical spinal cord injury 3. Non-progressive Spinal Cord Injury (SCI) at C2 - C7 (non-conus injury) 4. Motor Complete ASIA Impairment Scale (A, B, or C) 5. Severe respiratory function compromise requiring dependency on invasive or noninvasive ventilation 6. Able to attend weekly testing sessions for up to 21 months. 7. Have intact chest/lung, upper and lower extremity anatomy. The neuromuscular connections between the spinal cord and its effector muscles (respiratory and extremity) are required to be intact 8. Have intact cognitive ability, able to follow commands/voice concerns, and give consent Exclusion Criteria: 1. History of severe autonomic dysreflexia 2. Phrenic nerve or diaphragm pacer 3. Phrenic nerve paralysis 4. Musculoskeletal dysfunction, unhealed fracture, pressure ulcer of grade 3 and above in the European Pressure Ulcer Advisory Panel Grading System, active infection 5. Clinically significant depression or ongoing drug abuse as documented in the medical record 6. Received lung surgery within one year prior to study enrollment or has active intrinsic lung disease (e.g. COPD, acute or chronic lung infection, moderate to severe asthma, emphysema, cystic fibrosis, etc.) 7. Cardiopulmonary disease that precludes training or rehabilitation 8. Other implanted stimulation devices 9. Pregnant 10. Severe cardiac disease (e.g. heart failure, atherosclerosis, arrhythmia, stroke, etc.) 11. Subjects involved in other clinical trials not associated with this trial 12. Botox injections in respiratory associated muscles within the last 3 months
Where this trial is running
Los Angeles, California and 1 other locations
- Semel Institute of Neuroscience at UCLA — Los Angeles, California, United States (Recruiting)
- UCLA Clinical and Translational Research Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Daniel C Lu, MD, PhD — University of California, Los Angeles
- Study coordinator: Daniel C Lu, MD, PhD
- Email: DCLu@mednet.ucla.edu
- Phone: 310-267-2975
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.