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

Case Western Reserve University5 enrolled

Overview

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.

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

Purpose

TREATMENT

Enrollment

Conditions

Quadriplegia

Interventions

Medlink spinal cord electrodeDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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