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

Primary Purpose

Quadriplegia

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Medlink spinal cord electrode

About this trial

This is an interventional treatment trial for Quadriplegia focused on measuring environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004415

First Posted

October 18, 1999

Last Updated

April 6, 2015

Sponsor

Case Western Reserve University

1. Study Identification

Unique Protocol Identification Number

NCT00004415

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2002

Overall Recruitment Status

Terminated

Study Start Date

May 1991 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Case Western Reserve University

4. Oversight

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Quadriplegia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Enrollment

5 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Medlink spinal cord electrode

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony F. DiMarco

Organizational Affiliation

Case Western Reserve University

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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