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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-05-31

Study Completion Date

2000-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Quadriplegia

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Medlink spinal cord electrode

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No