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Device

Laryngeal Pacing Device for Vocal Fold Paralysis

N/A
Recruiting
Led By David L. Zealear, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of incomplete bilateral vocal fold paralysis (severe paresis) which significantly impedes respiration, documented via medical records and confirmed during the onsite screening visit by a Vanderbilt board certified laryngologist via endoscopy, electromyography, and direct laryngoscopy, with NGA less than 20, representing severe laryngeal obstruction
Demonstrated glottal opening bilaterally (abductory response) upon percutaneous needle stimulation of PCA muscles (i.e. mean NGA ≥0.05 per vocal fold tested)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new laryngeal pacemaker device to see if it is safe and can help people with bilateral vocal fold paralysis.

Who is the study for?
Adults over 22 with bilateral vocal fold paralysis, who've had repeated botox treatments or nerve reinnervation surgery, may join this trial. They must show a certain level of glottal opening and be willing to follow the study's procedures. Those with autoimmune diseases, heart issues, implanted electronic devices, allergies to device materials or barium dye, significant swallowing difficulties or tracheal narrowing are excluded.Check my eligibility
What is being tested?
The trial is testing a laryngeal pacing device for safety and its ability to improve voice and breathing in patients with paralyzed vocal folds. It involves implanting a device that stimulates muscles responsible for opening the vocal cords during breathing.See study design
What are the potential side effects?
Potential side effects aren't specified but could include discomfort at the implant site, infection risk from surgery, possible allergic reactions to materials in the device or changes in voice quality.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe vocal cord paralysis that makes it hard to breathe, confirmed by a specialist.
Select...
My vocal cords open normally when tested.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Better voice quality as assessed by decrease in standard assessment testing (Consensus Auditory Perceptual Evaluation of Voice or CAPE-V).
Improved ventilation due to laryngeal pacing device as assessed by increase in standard assessment testing (peak inspiratory flow or PIF).
Secondary outcome measures
Better quality of life (QOL) outcomes due to laryngeal pacing device, self assessed via patient reported outcome surveys.
Increase in exercise tolerance due to laryngeal pacing device as assessed by treadmill testing.
Increased glottal area due to laryngeal pacing device as assessed by increase in normalized glottal area (NGA) results.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Early Activation of Laryngeal Pacing deviceExperimental Treatment1 Intervention
Early Activation of the laryngeal pacing device (n=4) at one-month post-implantation.
Group II: Delayed Activation of Laryngeal Pacing devicePlacebo Group1 Intervention
Delayed activation of the laryngeal pacing device (n=4) at two months post-implantation.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,184 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
328 Previous Clinical Trials
178,297 Total Patients Enrolled
David L. Zealear, PhDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
2 Total Patients Enrolled

Media Library

Laryngeal Pacing Device (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04028674 — N/A
Bilateral Vocal Fold Paralysis Research Study Groups: Early Activation of Laryngeal Pacing device, Delayed Activation of Laryngeal Pacing device
Bilateral Vocal Fold Paralysis Clinical Trial 2023: Laryngeal Pacing Device Highlights & Side Effects. Trial Name: NCT04028674 — N/A
Laryngeal Pacing Device (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04028674 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are partaking in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this research study is still open for enrolment; the protocol was initially released on January 14th 2021 and received its most recent update in October 6th 2022. To complete the trial 12 participants must be enrolled from a single site."

Answered by AI

Is enrollment ongoing for this clinical trial?

"Data from clinicaltrials.gov indicates that this experiment is actively seeking participants, with the original posting occurring on January 14th 2021 and the most recent edits being made October 6th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I have had unilateral vocal cord paralysis for the past 12 years as a result of a tumor near my vocal nerve. I was recently diagnosed with bilateral paralysis most likely from post treatment damage. My ENT mentioned the danger to my breathing and the possibility of a tracheostomy being needed if it gets much worse. I feel utterly defeated. I am young and have a wife and three young children. I am physically fit but I cannot communicate with people that I love or do the things that I want to do. A tracheostomy would further isolate me as I would no longer want to be seen except by those closest to me. These past 12 years have already been so exhausting. Pushing out words with one vocal cord was always difficult. Losing my voice has negatively affected my social physical and mental well-being tremendously. I am unable to coach my kids, interact socially in places with moderate levels of noise and now breathing is labored. I was encouraged when I read about the work being done at Vanderbilt to help people like me. I don’t think I can adequately express in words the importance that being included in a groundbreaking trial might have for me. It had the potential to give me back my voice and gift my life back to me in a way that I never thought possible. Thank you for considering.
PatientReceived no prior treatments
I have had unilateral vocal fold paralysis for the past 12 years as a result of a tumor near my vocal nerve. I was recently diagnosed with bilateral paralysis most likely from post treatment damage. This change has started to negatively impact my breathing and my ability to swallow liquids. My ENT mentioned the danger to my breathing and the possibility of a tracheotomy being needed if it gets much worse. I feel utterly defeated. I am young and have a wife and three young children. I am physically fit but I cannot communicate with people that I love or do things that most others take for granted. Losing my voice has negatively affected both my physical and mental well-being. Pushing out words with one vocal cord was always difficult and now with both cords paralyzed speaking is nearly impossible. I avoid social situations and going anywhere that there is even a moderate level of noise. In situations where I am forced to speak the looks of confusion and pity from strangers only adds to my self consciousness and stress. My youngest daughter is 12 years old and she has never heard the true sound of my voice. In the past I enjoyed volunteering and coaching in the community. I was able to get by with one vocal cord but now it is not an option. I fear that a tracheotomy would further isolate me as I would no longer want to be seen except by those closest to me. I was so encouraged when I read about the work being done at Vanderbilt to help people like me. I don't think I can express in words the importance that being included in this groundbreaking trial might have for me. It has the potential to give me back my voice, allow me to breathe easier and essentially gift my life back to me in a way that I never thought possible. Thank you for considering me for this opportunity. - Mark Rand.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Will I hear if I am not accepted fort this trial? And what is the timeline to hear from the trial coordinator?
PatientReceived no prior treatments
Would it be beneficial to make an appointment to be evaluated at Vanderbilt? Will I hear if I am not accepted to the trial?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx
David Zealear, PhD 2021. "Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04028674.
~3 spots leftby Dec 2025
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