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Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia Clinical research trials and Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia. Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia clinical trial. Subjects typically recieve the finest healthcare available for their Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.

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



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

For Condition: Spinal Cord Injury,Quadriplegia
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , Case Western Reserve University
Synopsis: OBJECTIVES: I. Determine the efficacy and safety of bilateral phrenic nerve pacing via electrodes surgically implanted into the diaphragm to achieve full-time artificial ventilation in patients with ventilator-dependent tetraplegia.
Details: PROTOCOL OUTLINE: Patients undergo laparoscopic implantation of intramuscular diaphragm electrodes and initial electrical stimulation. Following a 2-week recovery period, diaphragm pacing is initiated and performed according to a reconditioning program in which the duration and frequency of electrode stimulation is gradually increased. Patients receive electrode stimulation for 5-10 minutes/hour 8-10 hours/day on week 3, 15-20 minutes/hour 8-10 hours/day on weeks 4 and 5. On weeks 5-15, electrode stimulation time is increased until full-time diaphragm pacing is achieved. Patients are monitored daily on weeks 7-28 and then followed regularly thereafter.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - High cervical spinal cord transection resulting in tetraplegia - Respiratory failure for the past 6 months that requires chronic mechanical ventilatory support - Failure of vigorous attempts to wean from ventilatory support Normal bilateral phrenic nerve function required --Patient Characteristics-- Performance status: Stable condition Cardiovascular: No active cardiovascular disease Pulmonary: No active lung disease Other: - No active brain disease - No significant scoliosis, chest wall deformity, or obesity
Total Enrollment: 6

Location and Contact Information:

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

MetroHealth System *Recruiting*
Cleveland,  Ohio,  44109
United States
Recruiting Anthony  DiMarco 216-778-2362

Case Western Reserve University *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Anthony  DiMarco 216-778-2362


Additional Information:
Study ID Numbers:
  199/15631;  CWRU-99065-M-99,CWRU-FDR001839
Study Start Date: February 2000
Record last reviewed: February 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010374

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