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.

Condition	Treatment or Intervention
Spinal Cord Injury Quadriplegia	Device: intramuscular diaphragm electrodes

Further Study Details: 

Expected Total Enrollment:  6

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Ohio
      Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
      MetroHealth System, Cleveland,  Ohio,  44109,  United States; Recruiting

Study chairs or principal investigators

Anthony F. DiMarco,  Study Chair,  Case Western Reserve University   

Study ID Numbers:  199/15631; CWRU-FDR001839; CWRU-99065-M-99
Record last reviewed:  February 2001
Last Updated:  October 13, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010374
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08