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

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. Identifier: NCT00845442
Recruitment Status : Unknown
Verified January 2010 by University Hospitals Cleveland Medical Center.
Recruitment status was:  Recruiting
First Posted : February 18, 2009
Last Update Posted : January 13, 2010
Information provided by:
University Hospitals Cleveland Medical Center

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.

Condition or disease Intervention/treatment Phase
Vocal Cord Paralysis Device: pacemaker Phase 1

Detailed Description:
Data pending

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
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
Study Start Date : January 2006
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Intervention Details:
  • Device: pacemaker
    Placement of pacemaker over the chest wall to stimulate the larynx in the neck via a tunneled electrode

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00845442

Contact: Michael Broniatowski, MD 216 363 2556

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
Principal Investigator: Michael Broniatowski, MD University Hospitals Cleveland

Responsible Party: Michael Broniatowski, MD, University Hospitals of Cleveland health System Identifier: NCT00845442     History of Changes
Other Study ID Numbers: 08-03-16
NIH DC-0066854-01
IDE G980179 ( Other Identifier: Federal Drug Administration )
First Posted: February 18, 2009    Key Record Dates
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:
Vocal Cord Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases