At a glance
ClinicalIndex Comparison Record- ✓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 demonstrated by EMG and nerve conduction times
- ✕Co-morbid medical conditions that preclude surgery
- ✕Active lung disease (obstructive, restrictive or membrane diseases)
- ✕Active cardiovascular disease
- ✕Active brain disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-Center Pivotal Study of NeuRx RA/4 Ventilatory Assist Device
In Brief
A clinical study evaluating NeuRx DPS for Spinal Cord Injury and Quadriplegia. Completed, enrolled 54 participants across 5 sites in 2 countries.
Detailed Summary
OBJECTIVES: The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis. The hypothesis being tested in the clinical trial is that laparoscopic stimulation of the diaphragm at the motor point with intramuscular electrodes is safe and effective in providing significant ventilatory support to individuals who are otherwise dependant on a mechanical ventilator. Patients in our initial study group have all suffered from high-level spinal cord injury and were full-time dependant on positive pressure mechanical ventilation prior to inclusion.
Study Details
Timeline
Interventions
Laparoscopic implantation of diaphragm electrodes and subsequent pacing with the NeuRx DPS.