View Clinical Trial (Medical Research Study)
Dynamic Vocal Fold Abduction for Bilateral Paralysis
| City: |
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Cleveland |
| State: |
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Ohio |
| Zip Code: |
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44106 |
| Conditions: |
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Vocal Cord Paralysis |
| Purpose: |
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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.
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| Study Summary: |
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Data pending
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| Criteria: |
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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
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| NCT ID: |
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NCT00845442 |
| Primary Contact: |
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Principal Investigator Michael Broniatowski, MD University Hospitals Cleveland
Michael Broniatowski, MD Phone: 216 363 2556 Email: mbron@prodigy.net
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| Backup Contact: |
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N/A |
| Location Contact: |
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Cleveland, Ohio 44106 United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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