Laryngeal Pacing Device vs Repeated Botox Injections for BVFP

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 36
• Participant gender: All

Summary

The purpose of this project is to compare the safety and efficacy of a new treatment termed bilateral laryngeal pacing to a standard of care option, botulinum toxin A injections (Botox), for the treatment of bilateral vocal fold paralysis (BVFP). Participants will be randomized to receive either standard of care (SOC) treatment or implantation of laryngeal pacemaker. Longitudinal outcomes related to ventilation, voicing, and swallowing will be used to evaluate the efficacy of each treatment paradigm.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• 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 bilateral vocal fold paralysis, at least ten months prior to study enrollment. This 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.

• Demonstrated glottal opening bilaterally (abductory response) upon percutaneous needle stimulation of PCA muscles (i.e. mean NGA ≥0.05 per vocal fold tested).

Exclusion Criteria:

• History of cardiac dysrhythmias or implanted cardiac pacemaker

• 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

• Known allergy to Botulinum Toxin A (Botox)

• Patients with pre-existing liquid dysphagia

• Presence of significant tracheal narrowing

• Any anatomical abnormality that would jeopardize safe implantation, per the surgeon

• Any medical condition, that in the opinion of the principal investigator or treating physician, would jeopardize the outcome or welfare of the participant

• Any previous medical treatment that in the opinion of the principal investigator or treating physician would confound the effects of either repeated Botox injections or laryngeal pacing procedures

• Females who are pregnant or plan a pregnancy within 2 years. A pregnancy test will be done as part of the routine pre-operative assessment for all females of child-bearing potential.