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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-01

Study Completion Date

2010-11-01

Brief Summary

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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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Detailed Description

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Data pending

Conditions

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Vocal Cord Paralysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Caregivers Investigators

Interventions

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pacemaker

Placement of pacemaker over the chest wall to stimulate the larynx in the neck via a tunneled electrode

Intervention Type DEVICE

Eligibility 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No