Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

About

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 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

75 Years

Inclusion Criteria:

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 with less than or equal to 50% of Maximal Inspiratory Pressure or Maximal Expiratory Pressure of the participants' age and gender normalized values. Participants may enroll in the study with or without dependency to invasive/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 Criteria:

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 into the respiratory muscles within the last 3 months