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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004415
First Posted: October 19, 1999
Last Update Posted: April 7, 2015
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.
Information provided by:
FDA Office of Orphan Products Development
  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

Study Type: Interventional
Study Design: Primary Purpose: Treatment

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

Estimated Enrollment: 5
Study Start Date: May 1991
Estimated Study Completion Date: September 2000
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00004415


Sponsors and Collaborators
Case Western Reserve University
Investigators
Study Chair: Anthony F. DiMarco Case Western Reserve University
  More Information

ClinicalTrials.gov Identifier: NCT00004415     History of Changes
Other Study ID Numbers: 199/13307
CWRU-09169-M-91
CWRU-FDR000403
First Submitted: October 18, 1999
First Posted: October 19, 1999
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:
Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms