Laryngeal Pacing Device for Vocal Fold Paralysis

Overseen By Kate Von Wahlde, MJ, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

8 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device that helps people with paralyzed vocal cords breathe better. The device uses electrical signals to open the vocal cords when breathing in and relax them otherwise. This aims to improve breathing without affecting voice or swallowing. Electrical stimulation of the posterior cricoarytenoid muscle has been studied as a method to restore ventilation in patients with bilateral laryngeal paralysis.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Laryngeal Pacing Device treatment for vocal fold paralysis?

Research shows that laryngeal pacing, which involves electrical stimulation of certain throat muscles, has been promising in animal studies for treating vocal fold paralysis. In mini-pigs, the treatment successfully activated the muscles needed for opening the vocal folds, suggesting it could be a good alternative to current treatments. ^{1 2 3 4 5}

Is the Laryngeal Pacing Device safe for humans?

A first-in-human study evaluated the safety of the Laryngeal Pacemaker System for treating bilateral vocal fold paralysis, indicating it is being tested for safety in humans. Pre-clinical studies in animals, like mini-pigs, showed promising results with some minor issues like electrode dislocation, suggesting further clinical studies are needed to confirm safety. ^{1 2 3 4 5}

How does the Laryngeal Pacing Device treatment differ from other treatments for vocal fold paralysis?

The Laryngeal Pacing Device is unique because it uses electrical stimulation to synchronize the movement of paralyzed vocal fold muscles with the normal side, offering a dynamic solution compared to traditional static treatments. This approach aims to restore natural vocal fold movement, which is not achieved by standard treatments like microlaryngoscopic enlargement techniques. ^{3 4 5 6 7}

Research Team

David L. Zealear, PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I am willing and able to follow all study rules and attend all appointments.

I have severe vocal cord paralysis that makes it hard to breathe, confirmed by a specialist.

I had surgery to reconnect the nerves in my voice box over 10 months ago.

Exclusion Criteria

I still have trouble swallowing liquids even after trying common methods.

I have an illness related to an autoimmune condition.

My surgeon says I can safely have an implant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo implantation of the laryngeal pacing device followed by activation at one or two months post-implantation

2 months

Multiple visits for implantation and activation

Follow-up

Participants are monitored for safety and effectiveness of the laryngeal pacing device

3 months

Regular follow-up visits

Treatment Details

Interventions

• Laryngeal Pacing Device

Trial Overview 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.

Participant Groups

Group I: Early Activation of Laryngeal Pacing device Experimental Treatment 1 Intervention

Early Activation of the laryngeal pacing device (n=4) at one-month post-implantation.

Group II: Delayed Activation of Laryngeal Pacing device Placebo Group 1 Intervention

Delayed activation of the laryngeal pacing device (n=4) at two months post-implantation.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Laryngeal pacing via an implantable stimulator for the rehabilitation of subjects suffering from bilateral vocal fold paralysis: A prospective first-in-human study. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

An Endoscopic Cap Electrode for Posterior Cricoarythenoid Muscle Stimulation in a Porcine Model. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Unilateral and Bilateral Laryngeal Pacing for Bilateral Vocal Fold Paralysis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Pre-clinical evaluation of a minimally invasive laryngeal pacemaker system in mini-pig. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Laryngeal pacing as a treatment for vocal fold paralysis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Laryngeal pacemaker. II. Electronic pacing of reinnervated posterior cricoarytenoid muscles in the canine. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Electrical Stimulation of Vocal Fold Adduction Triggered by Laryngeal Electromyography Using a Custom Implant. [2023]