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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004415
Enrollment
5
Registered
1999-10-19
Start date
1991-05-31
Completion date
2000-09-30
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quadriplegia

Keywords

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

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

Interventions

DEVICEMedlink spinal cord electrode

Sponsors

Case Western Reserve University
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
No

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026