NCT00004415

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 1991

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1991

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2000

Completed
Last Updated

April 7, 2015

Status Verified

September 1, 2002

First QC Date

October 18, 1999

Last Update Submit

April 6, 2015

Conditions

Quadriplegia

Keywords

environmental/toxic disordersneurologic and psychiatric disordersrare diseasespinal cord injury

Interventions

Medlink spinal cord electrodeDEVICE

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

QuadriplegiaNeurologic ManifestationsMental DisordersRare DiseasesSpinal Cord Injuries

Condition Hierarchy (Ancestors)

ParalysisNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Anthony F. DiMarco

    Case Western Reserve University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

May 1, 1991

Study Completion

September 1, 2000

Last Updated

April 7, 2015

Record last verified: 2002-09