We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by University Hospitals Cleveland Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845442
First Posted: February 18, 2009
Last Update Posted: January 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospitals Cleveland Medical Center
  Purpose
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.

Condition Intervention Phase
Vocal Cord Paralysis Device: pacemaker Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Dynamic Vocal Fold Abduction for Bilateral Paralysis

Resource links provided by NLM:


Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Videotaping vocal cords and pulmonary function tests [ Time Frame: one year ]

Secondary Outcome Measures:
  • Tolerance of implanted device [ Time Frame: 3-6 months ]

Estimated Enrollment: 6
Study Start Date: January 2006
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: pacemaker
    Placement of pacemaker over the chest wall to stimulate the larynx in the neck via a tunneled electrode
Detailed Description:
Data pending
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845442


Contacts
Contact: Michael Broniatowski, MD 216 363 2556 mbron@prodigy.net

Locations
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Sub-Investigator: Dustin J Tyler, PhD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: Michael Broniatowski, MD University Hospitals Cleveland
  More Information

Responsible Party: Michael Broniatowski, MD, University Hospitals of Cleveland health System
ClinicalTrials.gov Identifier: NCT00845442     History of Changes
Other Study ID Numbers: 08-03-16
NIH DC-0066854-01
IDE G980179 ( Other Identifier: Federal Drug Administration )
First Submitted: December 26, 2007
First Posted: February 18, 2009
Last Update Posted: January 13, 2010
Last Verified: January 2010

Keywords provided by University Hospitals Cleveland Medical Center:
Bilateral vocal cord paralyses
Implanted laryngeal stimulator
vocal cord opening
pulmonary function tests

Additional relevant MeSH terms:
Paralysis
Vocal Cord Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases