Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries

NACompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

December 31, 2012

Conditions
Respiratory ParalysisDiaphragmatic ParalysisSpinal Cord Injury
Interventions
DEVICE

NeuRx RA/4 diaphragmatic pacemaker

"Patients will be implanted with 4 intramuscular electrodes, 2 in each hemi-diaphragm, using laparoscopic techniques.~The abdominal cavity is inflated with CO2 and 4 ports are inserted: one for optics, 2 for a probe containing a temporary electrode for mapping the diaphragm and the electrode insertion tool, and a smaller one for the output wires of the electrodes of the abdominal cavity. The intra-abdominal pressure variation during the stimulation test (mapping) will be measured externally by one of the ports.~Sites that provide the optimal response (greater region and magnitude) are noted.~Once the optimal site for electrode placement is identified two intramuscular electrodes are deployed in each hemi-diaphragm. The guide wires will come out of the peritoneum through the port placed in the xiphoid region. An additional electrode is placed subcutaneously in the upper abdomen. The instruments and ports are then removed and the incision sites closed."

Trial Locations (2)

Unknown

Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Synapse Biomedical

INDUSTRY

lead

University of Sao Paulo

OTHER

NCT01385384 - Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries | Biotech Hunter | Biotech Hunter