Status:
RECRUITING
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 safet...
Detailed 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 imp...
Eligibility Criteria
Inclusion
- Male or female 18-75 years
- At least 1 year from initial cervical spinal cord injury
- Non-progressive Spinal Cord Injury (SCI) at C2 - C7 (non-conus injury)
- Motor Complete ASIA Impairment Scale (A, B, or C)
- Severe respiratory function compromise requiring dependency on invasive or noninvasive ventilation
- Able to attend weekly testing sessions for up to 21 months.
- 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
- Have intact cognitive ability, able to follow commands/voice concerns, and give consent
Exclusion
- History of severe autonomic dysreflexia
- Phrenic nerve or diaphragm pacer
- Phrenic nerve paralysis
- Musculoskeletal dysfunction, unhealed fracture, pressure ulcer of grade 3 and above in the European Pressure Ulcer Advisory Panel Grading System, active infection
- Clinically significant depression or ongoing drug abuse as documented in the medical record
- 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.)
- Cardiopulmonary disease that precludes training or rehabilitation
- Other implanted stimulation devices
- Pregnant
- Severe cardiac disease (e.g. heart failure, atherosclerosis, arrhythmia, stroke, etc.)
- Subjects involved in other clinical trials not associated with this trial
- Botox injections in respiratory associated muscles within the last 3 months
Key Trial Info
Start Date :
September 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04883463
Start Date
September 27 2021
End Date
December 31 2028
Last Update
November 6 2025
Active Locations (2)
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1
Semel Institute of Neuroscience at UCLA
Los Angeles, California, United States, 90024
2
UCLA Clinical and Translational Research Center
Los Angeles, California, United States, 90095