What side effects are associated with this type of intervention?

Bilateral laryngeal pacing, a form of electrical stimulation, is being studied for its safety and efficacy in treating bilateral vocal fold paralysis (BVFP). Known side effects of similar treatments include mild device-associated adverse events such as a warm sensation, numbness, redness, itching, tingling, muscle spasm, and localized pain in areas like the arm, shoulder, and neck. There were no serious adverse events reported in the trials mentioned.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Bilateral Vocal Fold Paralysis (BVFP) similar to Bilateral Laryngeal Pacing (Electrical Stimulation) in the provided context. However, the context does discuss the evaluation of bilateral and unilateral stimulation of an implanted device to improve treatment outcomes in patients with BVFP, indicating ongoing research in this area. Generally, treatments for BVFP may include surgical interventions, voice therapy, and in some cases, electrical stimulation techniques, but specific FDA approvals for these methods are not detailed in the provided information.

What other types of research exist?

One promising alternative to Bilateral Laryngeal Pacing for BVFP patients is the use of botulinum toxin injections. Botulinum toxin has been studied for its effectiveness in treating essential voice tremor and has shown potential in improving voice quality by reducing muscle spasms. Another emerging treatment is the use of implantable devices for functional electrical stimulation, which can provide targeted muscle activation and improve vocal fold function. Additionally, advancements in regenerative medicine, such as stem cell therapy, are being explored for their potential to repair and regenerate damaged vocal fold tissues.

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Device

Laryngeal Pacing Device for Vocal Fold Paralysis

N/A

Waitlist Available

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)

Must not have

Persistent thin liquid dysphagia despite standard of care dysphagia management strategies (e.g. small sips, chin tuck, etc.)

Any active illness associated with an auto-immune disorder (such as diabetes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

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

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

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My vocal cords open normally when tested.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have an illness related to an autoimmune condition.

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My surgeon says I can safely have an implant.

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My windpipe is significantly narrowed.

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I am not pregnant and do not plan to become pregnant within the next 2 years.

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I have had lung infections due to paralysis of my vocal cords.

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I have serious heart problems like unstable chest pain or recent heart attack.

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My vocal cords are immobile due to narrowing or arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bilateral laryngeal pacing, a form of electrical stimulation, works by implanting electrodes to stimulate the laryngeal muscles, thereby improving voice and ventilation in patients with Bilateral Vocal Fold Paralysis (BVFP). This treatment is significant because it can restore the ability to speak and breathe more effectively, addressing the core challenges faced by BVFP patients. By directly stimulating the paralyzed muscles, this approach offers a targeted and potentially more effective solution compared to traditional methods, which may not provide the same level of functional improvement.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

869 Previous Clinical Trials

678,616 Total Patients Enrolled

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

339 Previous Clinical Trials

179,737 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

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