Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients
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|ClinicalTrials.gov Identifier: NCT00004415|
Recruitment Status : Terminated
First Posted : October 19, 1999
Last Update Posted : April 7, 2015
OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia who are not candidates for phrenic nerve pacing alone.
II. Evaluate the efficacy of the Medlink device to produce synchronous intercostal and diagram activation in these patients.
|Condition or disease||Intervention/treatment||Phase|
|Quadriplegia||Device: Medlink spinal cord electrode||Not Applicable|
PROTOCOL OUTLINE: Patients have a Medlink spinal cord electrode surgically implanted and attached to a radiofrequency receiver implanted subcutaneously over the anterior chest wall.
If substantial inspired volumes can be generated by intercostal pacing, a phrenic nerve cuff electrode and radiofrequency receiver are implanted, and patients undergo combined intercostal muscle and diaphragm pacing.
Completion date provided represents the completion date of the grant per OOPD records
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||5 participants|
|Study Start Date :||May 1991|
|Study Completion Date :||September 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004415
|Study Chair:||Anthony F. DiMarco||Case Western Reserve University|