Laryngeal Pacing Device vs Repeated Botox Injections for BVFP
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
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
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