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Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

Recruiting

Who can join

Ages 18 to 75 · All sexes

Full eligibility 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

About the 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.

What is being tested

Sponsor: University of California, Los Angeles · Participants: 12 · Started: Sep 27, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04883463

Locations in the U.S.

CaliforniaSemel Institute of Neuroscience at UCLA, Los Angeles
UCLA Clinical and Translational Research Center, Los Angeles

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.