Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
University of California, Los Angeles
Summary
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.
Description
There are five main phases to this study. The first phase is baseline testing, second phase is temporary implant, third phase is post-temporary implant mapping/treatment, fourth phase is permanent implant, and fifth phase is post-permanent implant treatment. Phase 1. Screening and Baseline testing/training (up to 6 months, UCLA Semel Institute for Neuroscience and Human Behavior), the purpose of which is to ensure that each subject begins with the full benefits achievable by standard rehabilitative respiratory therapy and has stable baseline of function before they begin epidural stimulation.…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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.…
Interventions
- DeviceEpidural stimulation
Epidural electrical stimulation implant weekly sessions for 21 months.
Locations (2)
- Semel Institute of Neuroscience at UCLALos Angeles, California
- UCLA Clinical and Translational Research CenterLos Angeles, California