Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator
Recruitment status was Recruiting
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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 |
- Videotaping vocal cords and pulmonary function tests [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- 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) |
-
Device: pacemaker
Data pending
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Michael Broniatowski, MD | 216 363 2556 | mbron@prodigy.net |
| United States, Ohio | |
| University Hospitals of Cleveland | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Sub-Investigator: Dustin J Tyler, PhD | |
| 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 Hospitals of Cleveland:
|
Bilateral vocal cord paralyses Implanted laryngeal stimulator vocal cord opening pulmonary function tests |
Additional relevant MeSH terms:
|
Vocal Cord Paralysis Paralysis Laryngeal Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases |
Vagus Nerve Diseases Cranial Nerve Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013