Improving breathing in patients with cervical spinal cord injuries using neuromodulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.