Suspended

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

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What is being tested

Medlink spinal cord electrode

Device
Who is being recruted

Central Nervous System Diseases+12

+ Nervous System Diseases

+ Paralysis

From 18 to 49 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 1991
See protocol details

Summary

Principal SponsorCase Western Reserve University
Last updated: April 7, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1991

Actual date on which the first participant was enrolled.

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

NCT00004415
Principal SponsorCase Western Reserve University
Last updated: April 7, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 49 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Central Nervous System DiseasesNervous System DiseasesParalysisPathologic ProcessesSigns and SymptomsSpinal Cord DiseasesPathological Conditions, Signs and SymptomsWounds and InjuriesTrauma, Nervous SystemDisease AttributesMental DisordersNeurologic ManifestationsQuadriplegiaSpinal Cord InjuriesRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers