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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Hospital Case Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00845442
First received: December 26, 2007
Last updated: January 12, 2010
Last verified: January 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, 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 Hospital Case Medical Center:

Primary Outcome Measures:
  • Videotaping vocal cords and pulmonary function tests [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerance of implanted device [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital Case Medical Center
Investigators
Principal Investigator: Michael Broniatowski, MD University Hospitals Cleveland
  More Information

No publications provided

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
Study First Received: December 26, 2007
Last Updated: January 12, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 24, 2014