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

This study has been terminated.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004415
First received: October 18, 1999
Last updated: April 6, 2015
Last verified: September 2002
  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

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: October 18, 1999
Last Updated: April 6, 2015
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

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

ClinicalTrials.gov processed this record on July 21, 2016