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

Dynamic Vocal Fold Abduction for Bilateral Paralysis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00845442
Enrollment
6
Registered
2009-02-18
Start date
2006-01-01
Completion date
2010-11-01
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vocal Cord Paralysis

Keywords

Bilateral vocal cord paralyses, Implanted laryngeal stimulator, vocal cord opening, pulmonary function tests

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.

Detailed description

Data pending

Interventions

DEVICEpacemaker

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

Sponsors

University Hospitals Cleveland Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Secondary

MeasureTime frame
Tolerance of implanted device3-6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026