Objective: To describe the benefits and risks of vocal fold augmentation treatment for patients with neurogenic dysphonia/dysphagia.

Background: Neurogenic dysphonia/dysphagia represents laryngeal dysfunction, usually with focal involvement of the vocal folds due to a peripheral or central neurologic disorder. Peripheral neurogenic causes include recurrent laryngeal nerve palsy; central causes include Parkinson’s disease, amyotrophic lateral sclerosis, stroke and multiple sclerosis. Some of these disorders may result in vocal fold insufficiency (VFI), or inadequate closure of the glottis. Other causes of VFI include vocal fold atrophy that is often age-related (presbylarynx). A common treatment for VFI is vocal fold augmentation (VFA) via injection of the vocal folds. Past studies regarding VFA have been limited to vocal fold atrophy and peripheral neurologic disorders and focused on a specific augmentation material.

Methods: This multisite, open-label, longitudinal registry aims to enroll ∼400 patients with VFI undergoing VFA for any etiology at up to 100 sites. The study began in 2015, and the planned duration of the registry is 5 years. Adult patients with a diagnosis of neurogenic dysphonia/dysphagia who are under active treatment with VFA are eligible to enroll. Prospective and retrospective data will be captured from patient medical records, including demographics, medical history, and comorbid conditions. Functional assessments for voice, swallowing, and cough are being captured before and after VFA treatment where available. Details concerning VFA treatment procedures (eg, product used, setting, injection information) are being recorded along with information on concomitant behavioral treatment for voice, speech, or swallowing disorders; laryngeal framework surgery. Adverse events and complications are being monitored for all patients throughout the duration of the registry.

Results: As of December 10, 2015, 49 patients have been recruited at 4 registry sites.

Conclusions: This registry will be the first of its kind to characterize the population of patients with neurogenic dysphonia/dysphagia who receive VFA treatment. The results are therefore expected to provide key insights into effective assessment procedures, treatment strategies, and outcomes for this patient population; these data will also inform the design of future clinical studies.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/strong-voice-design-of-a-multisite-open-label-longitudinal-registry-for-patients-with-neurogenic-dysphoniadysphagia-treated-with-vocal-fold-augmentation/