Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This is a phase 1 study of safety and feasibility of cervical spinal cord stimulator implantation in cervical SCI subjects who are ventilator dependent. The Investigators will be focusing on the safety and feasibility of this approach. Participants may qualify for the study if they are male or female 18-75 years old, are at least 1 year after original injury, have injury at C2 to C7 level, and dependent on mechanical ventilation to help them breathe. Additionally, they need to be able to attend up to twice weekly testing sessions for up to 21 months.
Sponsor: University of California, Los Angeles
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Los Angeles
Source: ClinicalTrials.gov · NCT04883463 · last updated 2025-11-06