Vocal Cord Paralysis

Researchers are studying a surgically implanted functional electrical stimulation (FES) system designed to improve stability of the trunk and hips in people with spinal cord injuries, paralysis, tetraplegia, or paraplegia. This system uses small electric currents to make muscles contract, aiming to help users sit more steadily, breathe better, reach farther, push a wheelchair, or roll in bed. The study is conducted by the VA Office of Research and Development and focuses on how this neuroprosthesis affects posture and mobility. The study involves one surgical procedure to implant electrodes into the trunk and hip muscles. These electrodes connect to an 8-channel stimulator implanted in the abdomen. After surgery, participants spend two to six weeks at home with limited activity to allow healing. Following this, they undergo exercise and training to begin using the neuroprosthesis functionally. Participants will be assessed in the lab for strength, balance, and functional abilities both with and without the system, while the implanted device’s technical performance is also monitored. Participants will be involved for up to 36 months, during which researchers will measure the effects of trunk stimulation on posture control, breathing, pressure distribution while seated, reach ability, stability, and personal mobility. They will also work on designing a simple position controller. The study includes post-operative training and follow-up visits to track progress, device function, and safety over time.

Swallowing disorders are common in intensive care unit (ICU) patients, especially those with tracheostomies that can cause changes affecting swallowing. These disorders are linked to serious problems like respiratory issues, poor nutrition, and even death. Current clinical exams lack precision, while existing tests like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES) are invasive, resource-heavy, and hard to access. Researchers are exploring ultrasound imaging as a non-invasive and precise method to assess swallowing disorders in difficult-to-wean tracheostomised ICU patients. This observational study will enroll 119 difficult-to-wean tracheostomised patients over nineteen months at multiple hospitals. Each patient will undergo FEES and ultrasound evaluations within a two-hour window. Ultrasound will assess movements and structures including the tongue, larynx, and suprahyoid muscles. The ultrasonographer will be blinded to other assessments. The goal is to develop a diagnostic ultrasound model using selected variables, which will be transformed into an easy-to-use scoring system to predict swallowing disorders. Participants will be assessed through clinical data collection and swallowing tests. Ultrasound exams will measure features like tongue thickness and muscle contractions, while FEES will evaluate swallowing function and residue severity. Reliability tests will be done with multiple examiners. Researchers will analyze data statistically to create and validate the ultrasound score’s accuracy and reliability. The study aims to improve early detection and management of swallowing disorders non-invasively, over the course of the study period ending in April 2026.

Researchers are studying the accuracy of a new device called the laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER) to measure throat sensitivity in patients suspected of having obstructive sleep apnea (OSA). This prospective, double-blinded, randomized crossover trial aims to validate this device's measurements by comparing them to standard sleep study results. The study focuses on understanding sensory differences in patients with mild, moderate, and severe OSA and improving knowledge about OSA’s underlying mechanisms. The study involves patients referred for a baseline sleep test who will undergo a sensory test using the LPEER, which delivers air pulses of varying intensity to specific throat areas: the velopharynx, hypopharynx, and aryepiglottic folds. Experienced and less experienced pulmonologists or otolaryngologists will perform these tests to assess measurement reliability. The study design includes randomized crossover assignment of raters to evaluate intra- and inter-rater agreement and diagnostic accuracy through detailed statistical analyses. Participants will attend the sleep laboratory where they will receive the sensory test alongside their routine sleep study. Researchers will measure sensory thresholds at three throat sites and collect data related to sleep apnea severity, oxygen levels, and any adverse events. The study will last up to 15 days for each participant, during which safety and test accuracy will be closely monitored. Results will help determine the usefulness of LPEER for future clinical evaluation and monitoring of OSA patients.

Researchers are evaluating an artificial intelligence-assisted system designed to improve the detection of anatomical sites and lesions during nasopharyngolaryngoscopy, a procedure used to examine the nasopharynx and larynx. The study aims to address challenges of traditional procedures such as incomplete visualization and unclear imaging by training and validating a deep learning model using collected images and patient data from multiple centers. The study involves collecting electronic nasopharyngolaryngoscopy images and baseline patient information, including gender and age, to train and validate the AI model. Initially, the model is trained using a retrospective dataset and internally validated. Subsequently, the clinical performance of the model is assessed prospectively by enrolling patients, collecting new nasopharyngolaryngoscopy videos, and testing the model against this independent dataset. Participants will undergo standard nasopharyngolaryngoscopy exams, with their images and videos collected for analysis. Researchers will compare the model’s lesion detection and anatomic site recognition performance to that of physicians. Outcome measures are evaluated within three months after completing data collection. The study runs from December 2025 to March 2027 and includes assessments of diagnostic accuracy and comparative performance between the AI system and medical professionals.

Researchers are evaluating the safety and effectiveness of the APrevent4 VOIS Implant for treating patients with permanent unilateral vocal fold paralysis (UVFP). This prospective, two-part, multi-center, open-label, non-randomized clinical trial plans to enroll 30 patients. Part A focuses on safety assessment with sequential groups, followed by Part B which assesses device performance. The study is conducted by APrevent Biotech GmbH and aims to improve voice quality in affected patients. The investigational device, APrevent4 VOIS, is implanted permanently during a type I thyroplasty surgery in individuals with UVFP. The study includes two parts: Part A enrolls 8 patients in three groups with safety reviews after each group's first follow-up, and Part B assesses effectiveness after enrollment. There is no placebo or randomization. Four post-operative visits are scheduled at Week 1, Week 7, Month 6, and Month 12 to monitor participants. Participants will undergo assessments including voice quality measurement using the GRBAS Scale and Maximum Phonation Time. Follow-up visits involve clinical evaluations to monitor safety and performance of the implant. The primary outcome is the change in G-Score from the GRBAS Scale at 7 weeks post-implantation. Secondary outcomes include changes in maximum phonation time. Participants are followed for up to 12 months with evaluations to track progress and any side effects.

This research aims to develop a screening tool for oropharyngeal dysphagia, a swallowing disorder common in neurological patients such as those with Parkinson's disease, stroke, or amyotrophic lateral sclerosis. Dysphagia can lead to serious complications like malnutrition, dehydration, and pneumonia, increasing hospital stays and healthcare costs. Currently, there are no fast and effective screening methods available outside specialized clinical settings. Participants in this study perform various voice tasks during a single session, including sustained phonation, rapid syllable repetition, standardized sentences, and free speech. The recorded voice signals are analyzed using machine learning algorithms to identify changes related to swallowing difficulties. The study includes patients with neurological disorders both with and without dysphagia, as well as healthy individuals, to help develop the classification algorithm. During the study visit, participants provide voice recordings and clinical and medical history information. Researchers use these data to extract acoustic features for the machine learning model. The main goal is to create an algorithm that can quickly and non-invasively screen for swallowing disorders in neurological patients. The study is observational and involves a single recording session with no additional treatments or interventions.

Researchers are evaluating the use of EEG-based Brain-Computer Interface (BCI) technology to detect awareness and enable communication in people with prolonged disorders of consciousness (DoC), such as unresponsive wakefulness syndrome (UWS), minimally conscious state (MCS), and locked-in syndrome (LIS). The study aims to improve diagnosis accuracy where traditional methods relying on motor responses may fail, and to explore if BCI can provide movement-independent communication. The trial also investigates whether training with BCI can enhance brain response consistency and communication ability. Participants undergo three phases: Phase I assesses if patients can imagine movements and produce detectable brain activity using EEG. Phase II involves training with motor imagery BCI and real-time auditory feedback to help participants modulate brain signals. Phase III tests participants' ability to answer yes-no questions using imagined movement patterns. The study uses specific imagined movement combinations to represent 'yes' or 'no' responses, tailored individually and applied throughout sessions lasting about 1.5 hours each. During the study, participants complete up to 10 sessions including assessments, training, and communication tasks. Researchers monitor changes in BCI performance accuracy, ability to communicate consistently, and clinical scale scores related to consciousness and recovery. The study evaluates how feedback types and timing affect performance and collects data to support clinical diagnosis and potential therapeutic benefits. Participation involves EEG recordings, neurofeedback, and answering structured questions over several weeks.

Researchers are investigating disorders affecting the head and neck to improve understanding and aid in developing better treatments. This observational study aims to create a biorepository of both diseased and normal tissue samples from individuals with head and neck conditions. The research is conducted by the National Cancer Institute and focuses on collecting valuable biological materials for future studies related to these disorders. Participants diagnosed with head and neck conditions can contribute by allowing leftover tissue samples from their clinical care or previous research to be stored for study. The study has two parts: Part 1 involves sharing surgical waste specimens for research, while Part 2 includes additional sample collection such as blood draws, cheek swabs, saliva collection, and, for adults 18 and older, optional skin or mucosal biopsies. No experimental treatments are given during this study. During the study, participants will undergo screening including questionnaires, medical history review, and physical exams. Samples collected will be used for genetic and molecular research. The primary outcome is to establish a repository of tissue specimens by December 2026. Participant involvement may include providing permission for sample use, additional sample collection, and ongoing sharing of specimens for approved research projects. The study continues to share samples for cellular and genetic analysis to support future research on head and neck disorders.

This research aims to understand primary muscle tension dysphonia, a voice disorder marked by vocal strain and fatigue, which affects quality of life. The study focuses on early career and student female teachers, exploring how stress influences voice and speech control in the brain. Researchers will compare brain imaging, saliva samples, personality traits, and voice muscle activity between teachers with vocal fatigue and those without, to reveal stress-related patterns affecting voice production. Participants are divided into two groups: teachers with vocal fatigue and control participants without vocal fatigue. Both groups undergo two main experiments. The first includes MRI scans with surface electrodes on the neck and audio recordings during stress and non-stress conditions, along with saliva collection and emotional state ratings. The second experiment, about two weeks later, involves speech tasks with neck muscle sensors and audio recordings, accompanied by questionnaires and subjective effort ratings. Throughout the study, participants complete questionnaires on voice, personality, and stress, and provide saliva samples before, during, and after MRI scans. Researchers measure vocal fatigue, brain activity in specific areas, muscle activity in neck muscles, salivary cortisol levels, personality traits, and subjective vocal and cognitive effort. The study lasts about one month, with detailed monitoring to better understand stress's role in vocal fatigue and voice disorders in this population.

Researchers are conducting a multicenter retrospective observational study to identify and describe vocal cord lesions that cause dysphonia in patients with systemic autoimmune diseases. The study focuses on understanding the types of lesions, such as "bamboo nodes" and other specific or non-specific lesions, their diagnosis timing, and treatment approaches in conditions like rheumatoid arthritis, systemic lupus erythematosus, and other connective tissue diseases. The study involves reviewing medical records from January 2014 to December 2024 to characterize vocal cord lesions responsible for dysphonia. The research examines patient histories for lesions like fibrosis, immune complex deposits, rheumatoid nodules, granulomas, and other mucosal abnormalities. Treatment methods like vocal therapy, oral steroids, surgery, and avoiding irritants are noted, though management varies due to the rarity of these conditions. Participants' records will be reviewed for lesion type as diagnosed by specialists such as otorhinolaryngologists or rheumatologists. The study assesses diagnosis delays, lesion management, and associated risk factors. Participants will not undergo new treatments but will have their medical histories analyzed to better understand dysphonia causes in autoimmune disease contexts.