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Clinical Trials/NCT00845442
NCT00845442
Completed
Not Applicable

Dynamic Vocal Fold Abduction for Bilateral Paralysis

University Hospitals Cleveland Medical Center1 site in 1 country6 target enrollmentJanuary 1, 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vocal Cord Paralysis
Sponsor
University Hospitals Cleveland Medical Center
Enrollment
6
Locations
1
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

People who had paralysis of the vocal cords are often prevented from breathing by this problem because the cords will not open, and the patients have to wear a tracheostomy (neck breathing tube) to bypass this airway obstruction. This study examines the effects of vocal cord opening triggered by a pacemaker implanted over the chest wall. The device is connected to a nerve taken from a muscle close to the larynx (voice box) and implanted into the paralysed laryngeal muscle so it can reinnervate it. When this process is complete after a few weeks, the stimulator is turned on and the level of vocal cord opening is assessed. Airway improvement is checked by pulmonary function tests and measurements of vocal cord opening. The ultimate goal of the study is to lead to situations where patients with bilateral vocal fold paralyses could get rid of the neck breathing tube to have less complications, be more comfortable and socially acceptable.

Detailed Description

Data pending

Registry
clinicaltrials.gov
Start Date
January 1, 2006
End Date
November 1, 2010
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Breathing difficulties from vocal cord paralyses
  • Tracheostomy tube
  • Ability to understand the purpose of the research
  • Appropriate hand motor coordination

Exclusion Criteria

  • Lack of understanding the research
  • Poor hand motor coordination
  • Non-acceptance of tracheostomy
  • Inability to passively move the paralyzed vocal cords

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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