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

NCT00845442 | Completed

• 3 other identifiers: 08-03-16NIH DC-0066854-01IDE G980179
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Vocal Cord Paralysis

Keywords

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

Outcome Measures

Secondary Outcomes (1)

• Tolerance of implanted device

  3-6 months

Interventions

pacemaker DEVICE

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breathing difficulties from vocal cord paralyses
• Tracheostomy tube
• Ability to understand the purpose of the research
• Appropriate hand motor coordination

You may not qualify if:

• Lack of understanding the research
• Poor hand motor coordination
• Non-acceptance of tracheostomy
• Inability to passively move the paralyzed vocal cords

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Broniatowski, MD

  University Hospitals Cleveland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: February 18, 2009
• Study Start: January 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: November 1, 2010
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

US (1)