Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx

NCT04028674 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 2009325U01DC016033-05
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this project is to evaluate the safety of new treatment termed bilateral laryngeal pacing to improve treatment outcomes in patients with bilateral vocal fold paralysis (BVFP) (Aim 1). Outcome measures related to voice and ventilation will also provide initial insights into the efficacy of bilateral (Aim 2) and unilateral (Aim 3) stimulation of the implanted device to improve treatment outcomes in patients with BVFP.

Conditions

Bilateral Vocal Fold Paralysis (BVFP)

Outcome Measures

Primary Outcomes (2)

• Improved ventilation due to laryngeal pacing device as assessed by increase in standard assessment testing (peak inspiratory flow or PIF).

  12 months

• Better voice quality as assessed by decrease in standard assessment testing (Consensus Auditory Perceptual Evaluation of Voice or CAPE-V).

  12 months

Secondary Outcomes (3)

• Increased glottal area due to laryngeal pacing device as assessed by increase in normalized glottal area (NGA) results.

  12 months

• Increase in exercise tolerance due to laryngeal pacing device as assessed by treadmill testing.

  12 months

• Better quality of life (QOL) outcomes due to laryngeal pacing device, self assessed via patient reported outcome surveys.

  12 months

Study Arms (2)

Early Activation of Laryngeal Pacing device

EXPERIMENTAL

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

Device: Laryngeal Pacing Device

Delayed Activation of Laryngeal Pacing device

SHAM COMPARATOR

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

Device: Laryngeal Pacing Device

Interventions

Laryngeal Pacing Device DEVICE

Device is an implantable neurostimulation system designed to deliver low-intensity electrical impulses to nerve structures.

Delayed Activation of Laryngeal Pacing device; Early Activation of Laryngeal Pacing device

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Willingness to comply with all study procedures and availability for the duration of the study.
• Male or female adult patients, 22 years of age or older.
• Diagnosis of one of the following at least ten months prior to study enrollment:
• Complete bilateral vocal fold paralysis, with suspected etiological event occurring at least ten months prior to study enrollment. Diagnosis will be documented via medical records and confirmed during the onsite screening visit by a Vanderbilt board certified laryngologist via endoscopy, electromyography and direct laryngoscopy.
• Incomplete bilateral vocal fold paralysis (severe paresis) which significantly impedes respiration may also be considered for participation under the same conditions and per physician recommendation. Patients must present with an NGA less than 20, representing severe laryngeal obstruction. Diagnosis will be documented via medical records and confirmed during the onsite screening visit by a Vanderbilt board certified laryngologist via endoscopy, electromyography, and direct laryngoscopy.
• Patients receiving repeated botulinum toxin (botox) injections into the thyroarytenoid muscle to treat BVFP may be eligible for participation per physician recommendation.
• Demonstrated glottal opening bilaterally (abductory response) upon percutaneous needle stimulation of PCA muscles (i.e. mean NGA ≥0.05 per vocal fold tested).
• Patients who have previously undergone a recurrent laryngeal nerve reinnervation procedure may be eligible for participation per physician recommendation. Patients must have undergone the laryngeal nerve reinnervation surgery at least 10 months prior to enrollment in the laryngeal pacing study.
• Patients who have previously undergone a recurrent laryngeal nerve reinnervation procedure may be eligible for participation per physician recommendation. Patients must have undergone the laryngeal nerve reinnervation surgery at least 10 months prior to enrollment in the laryngeal pacing study.
• Patients with or without a tracheostomy
• Demonstrated glottal opening bilaterally (abductory response) upon percutaneous needle stimulation of PCA muscles (i.e. mean NGA ≥0.05 per vocal fold tested).

You may not qualify if:

• Any active illness that is associated with an auto-immune disorder (such as diabetes).
• History of cardiac dysrhythmias or implanted cardiac pacemaker.
• Cardiac irregularities identified in screening electrocardiogram.
• Any electronic implanted medical device that, in the investigator's opinion, could interact with the laryngeal pacemaker.
• Active cardiac disease manifested by unstable angina, recent myocardial infarction, malignant arrhythmias, uncontrolled hypertension (diastolic greater than 110), or decompensated congestive heart failure.
• Patients with underlying comorbidities that, in the investigator's opinion, could potentially warrant a need for oxygen therapy, including but not limited to: Chronic obstructive pulmonary disease, asthma, emphysema, recurrent bronchitis, pneumonia or interstitial lung disease.
• Bilateral laryngeal immobility from stenosis or arthritis.
• Poor surgical risk patients as determined by the treating surgeon or Vanderbilt Preoperative Evaluation Center (VPEC).
• The abundance of interstitial fat may impede the surgical dissection. In the opinion of the principal investigator or treating physician(s), patients with factors that may complicate the surgical intervention will be excluded.
• Known allergy to barium dye or anesthetics.
• Known allergy to any of the device materials.
• History of aspiration pneumonia, secondary to bilateral vocal fold paralysis
• Persistent thin liquid dysphagia despite standard of care dysphagia management strategies (e.g. small sips, chin tuck, etc.)
• Presence of significant tracheal narrowing.
• Any anatomical abnormality that would jeopardize safe implantation, per the surgeon.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Study Officials

• David L. Zealear, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The blinded procedures include PIF, CAPE-V, NGA, X-Tol. * PIF: A research staff member will be unblinded and control the pacer programmer. The testing condition will be programmed prior to start of test. Both patient and staff administering the test will be blinded to testing condition. * CAPE-V: Clinically-certified SLPs involved in perceptual ratings of voice quality will be blinded to experimental testing condition and data collection timepoint. * NGA: NGA is analyzed from stills of the glottis collected during endoscopy. These images will be randomized and de-identified before analysis to blind the rater. * X-Tol: A research staff member will be unblinded and control the pacer programmer. The testing condition will be programmed prior to start of test. Both patient and staff administering the test will be blinded to testing condition.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Otolaryngology

Model Details: Following implantation of the laryngeal pacing device and post-operative visit, participants will be randomized to their treatment group (Early Activation vs. Delayed Activation) and unilateral stimulation side (Right PCA vs. Left PCA) using the REDCap randomization module. 1. To treatment group at a 1:1 ratio-Either the Early Activation Group (n=4) or the Delayed Activation Group (n=4) 2. To unilateral stimulation side at a 1:1 ratio-The side for unilateral stimulation will be either the left PCA muscle (n=4), or the right PCA muscle (n=4)

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 23, 2019
• Study Start: January 14, 2021
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)