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Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator

Primary Purpose

Vocal Cord Paralysis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pacemaker
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Vocal Cord Paralysis focused on measuring Bilateral vocal cord paralyses, Implanted laryngeal stimulator, vocal cord opening, pulmonary function tests

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals of Cleveland

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Tolerance of implanted device

Full Information

First Posted
December 26, 2007
Last Updated
July 18, 2022
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00845442
Brief Title
Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator
Official Title
Dynamic Vocal Fold Abduction for Bilateral Paralysis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2006 (Actual)
Primary Completion Date
January 1, 2009 (Actual)
Study Completion Date
November 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord Paralysis
Keywords
Bilateral vocal cord paralyses, Implanted laryngeal stimulator, vocal cord opening, pulmonary function tests

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigator
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
pacemaker
Intervention Description
Placement of pacemaker over the chest wall to stimulate the larynx in the neck via a tunneled electrode
Secondary Outcome Measure Information:
Title
Tolerance of implanted device
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Broniatowski, MD
Organizational Affiliation
University Hospitals Cleveland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator

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