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

Quadriplegia Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00004415
• Other study ID #: 199/13307
• Secondary ID: CWRU-09169-M-91C
• Status: Terminated
• Phase: N/A
• First received: October 18, 1999
• Last updated: April 6, 2015
• Start date: May 1991
• Est. completion date: September 2000

Study information

• Verified date: September 2002
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Quadriplegia

Intervention

Device:
• Medlink spinal cord electrode

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University