What are the voice quality and respiratory function effects of neurostimulation with the laryngeal pacemaker (LP) system in patients with bilateral vocal fold paralysis (BVFP)?
LP system neurostimulation results in an immediate and stable peak expiratory flow (PEF) improvement, without negative effects on the voice quality.
Explore This IssueAugust 2017
Background: Although transoral laser surgical glottic enlargement is considered the gold-standard treatment for BVFP, respiratory function improvement often correlates with voice quality deterioration due to the irreversible and static modification of the vocal fold conformation. Selective neurostimulation could be a promising BVFP therapy based on the dynamic restoration of vocal fold mobility.
Study design: Feasibility study, first-in-human, single-arm, open-label, prospective, multicenter study with group-sequential design and six-month post-implantation period of nine symptomatic BVFP subjects.
Synopsis: The evaluated voice quality parameters (MPT [glottal competence]; F0 range in semitones and the sound pressure level [SPL] range in decibels [correlation between changes in the vocal fold tension and subglottal air pressure]; jitter analysis [fundamental frequency perturbation of a sustained vowel]; and the Dysphonia Severity Index [a combination of objective measures of vocal performance]) did not change significantly from the pre- to the six-month post-implantation visit. The SPL range was the only parameter to show a significant improvement six months post-implantation.At the post-implantation visit, videolaryngoscopy descriptive evaluation showed that the targeted vocal fold responded to the neurostimulation by shifting from a paramedian to a lateral position (abduction), resulting in a dynamic and transient enlargement of the glottal gap nearly mimicking the physiological situation of a healthy vocal fold during respiration. During phonation, the physiological adduction overrode the stimulated abduction, and both vocal folds were driven back in a median position. Weekly self-assessment with a PEF meter showed significant improvement a week after LP system activation.