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

This study has been suspended.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Case Western Reserve University
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004415

Purpose

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.

Condition	Intervention
Quadriplegia	Device: Medlink spinal cord electrode

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	5
Study Start Date:	May 1991

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.

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004415

Sponsors and Collaborators

FDA Office of Orphan Products Development

Case Western Reserve University

Investigators

Study Chair:

Anthony F. DiMarco

Case Western Reserve University

More Information

No publications provided

Study ID Numbers:	199/13307, CWRU-09169-M-91, CWRU-FDR000403
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004415 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

environmental/toxic disorders
neurologic and psychiatric disorders
rare disease
spinal cord injury

Study placed in the following topic categories:

Paralysis
Signs and Symptoms
Spinal Cord Injuries
Mental Disorders

Rare Diseases
Neurologic Manifestations
Quadriplegia

Additional relevant MeSH terms:

Paralysis
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Quadriplegia

ClinicalTrials.gov processed this record on May 07, 2009