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

April 6, 2015 updated by: Case Western Reserve University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment

5

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1991

Study Completion

September 1, 2000

Study Registration Dates

First Submitted

October 18, 1999

First Submitted That Met QC Criteria

October 18, 1999

First Posted (Estimate)

October 19, 1999

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

September 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/13307
  • CWRU-09169-M-91
  • CWRU-FDR000403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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