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Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients



Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients

For Condition: Quadriplegia
Status: Suspended
Sponsor(s): FDA Office of Orphan Products Development , Case Western Reserve University
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/49 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Ventilator dependent quadriplegics who are not candidates for phrenic nerve pacing alone Must have bilateral partial or unilateral phrenic nerve function Must have been on ventilator support for at least 6 months and unweanable --Patient Characteristics-- Cardiovascular: No active cardiovascular disease Pulmonary: No active lung disease Other: No active brain disease Stable condition
Total Enrollment: 5

Location and Contact Information:

Overall Study Official:
AnthonyDiMarco,  Study Chair,  Case Western Reserve University


Additional Information:
Study ID Numbers:
  199/13307;  CWRU-09169-M-91,CWRU-FDR000403
Study Start Date: May 1991
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004415

Other Quadriplegia Studies:
1. Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients

2. Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia

3. Retraining Walking after Spinal Cord Injury

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