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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004415
Recruitment Status : Terminated
First Posted : October 19, 1999
Last Update Posted : April 7, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:

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 or disease Intervention/treatment Phase
Quadriplegia Device: Medlink spinal cord electrode Not Applicable

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  (Clinical Trial)
Enrollment : 5 participants
Primary Purpose: Treatment
Study Start Date : May 1991
Study Completion Date : September 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004415

Sponsors and Collaborators
Case Western Reserve University
Study Chair: Anthony F. DiMarco Case Western Reserve University Identifier: NCT00004415     History of Changes
Other Study ID Numbers: 199/13307
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: September 2002

Keywords provided by FDA Office of Orphan Products Development:
environmental/toxic disorders
neurologic and psychiatric disorders
rare disease
spinal cord injury

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms