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


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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

This study is currently recruiting patients.

Sponsored by:	FDA Office of Orphan Products Development Case Western Reserve University
Information provided by:	FDA Office of Orphan Products Development

Purpose

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

MedlinePlus related topics: Paralysis; Spinal Cord Injuries

Study Type: Interventional
Study Design: Treatment

Further Study Details:

Expected Total Enrollment: 6

Study start: February 2000

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

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

Location and Contact Information

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

Anthony F. DiMarco 216-778-2362

MetroHealth System, Cleveland, Ohio, 44109, United States; Recruiting

Anthony F. DiMarco 216-778-2362

Study chairs or principal investigators

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

More Information

Study ID Numbers: 199/15631; CWRU-FDR001839; CWRU-99065-M-99
Record last reviewed: February 2001
Record first received: February 2, 2001
ClinicalTrials.gov Identifier: NCT00010374
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09

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