Electrical Activation of The Diaphragm for Ventilatory Assist
Spinal Cord Injury, Quadriplegia
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Diaphragm for Ventilatory Assist, environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Cervical spinal cord injury dependent on mechanical ventilation Clinically stable following acute spinal cord injury Bilateral phrenic nerve function clinically acceptable as demonstrated with EMG recordings and nerve conduction times Diaphragm movement with stimulation visible under fluoroscopy Clinically acceptable oxygenation on room air (>90%) Hemodynamically stable No medical co-morbidities that would interfere with the proper placement or function of the device Committed primary caregiver Negative pregnancy test in females of child-bearing potential Informed consent from patient or designated representative Exclusion Criteria: Co-morbid medical conditions that preclude surgery Active lung disease (obstructive, restrictive or membrane diseases) Active cardiovascular disease Active brain disease Hemodynamic instability or low oxygen levels on room air Hospitalization for or a treated active infection within the last 3 months Significant scoliosis or chest deformity Marked obesity Anticipated poor compliance with protocol by either patient or primary caregiver Currently breastfeeding
Sites / Locations
- Craig Hospital
- Shepherd Center
- University Hospital Of Cleveland
- The Methodist Hospital
- Vancouver CoastHealth
Arms of the Study
Arm 1
Experimental
NeuRx DPS
Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.