Assess speech and swallowing function
- Trial ID
- NCT04706234
- Official Title
- Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases
- Goal
- Assess speech and swallowing function
- Status
- RECRUITING
- Sponsor
- Kliniken Beelitz GmbH
- Study Type
- OBSERVATIONAL
- Enrollment
- 350 participants
- Conditions
- Multiple System Atrophy, Parkinson Disease, Progressive Supranuclear Palsy, Motor Neuron Disease, Neurodegenerative Diseases
Plain-Language Summary
The goal is to map and quantify laryngopharyngeal function, meaning swallowing, voice and airway protection, in people with Parkinson's and similar neurodegenerative diseases, so clinicians can better detect aspiration risk and tailor care. Participants get a FEES exam using a validated task protocol, where a thin camera is passed through the nose to watch the larynx and pharynx during specific tasks and swallows, allowing direct observation of secretions, airway closure, and swallow timing. This is observational, it does not change treatments like levodopa, it simply documents how these functions vary across diseases and stages. Adults 18 and older with diagnoses such as Parkinson's, multiple system atrophy, progressive supranuclear palsy, motor neuron disease, or other neurodegenerative disorders are eligible if they completed the FEES protocol and gave consent; Parkinson's cases can be Hoehn and Yahr stage I through V.
Locations
- Department of Neurology and Department of ENT, Medical University Innsbruck, Innsbruck, Tyrol, Austria
- Department of Neurology, Medical University of Ulm, Ulm, Baden-Wurttemberg, Germany
- Movement Disorders Hospital - Kliniken Beelitz, Beelitz-Heilstätten, Brandenburg, Germany
- Department of Neurology, Medical School Hannover, Hanover, Lower Saxony, Germany
- Department of Neurology, University Hospital Münster, Münster, North Rhine-Westphalia, Germany
- Department of Neurology, University Hospital Carl Gustav Carus, Dresden, Saxony, Germany
- Department of Neueology Asklepios Klinik Stadtroda, Stadtroda, Thuringia, Germany
- Asklepios Fachklinikum Stadtroda, Stadtroda, Thuringia, Germany
- Asklepios Klinik Barmbek, Hamburg, Germany
- Department of Neurology Asklepios Klinik Barmbek, Hamburg, Germany
- Department of Neurology, Movement Disorders Unit, Medical Center Tel Aviv, Tel Aviv, Israel
- IRCCS Istituto delle Scienze Neurologiche, Azienda USL di Bologna, Bologna, Italy
- Department of Neurology, Gifu University Graduate School of Medicine, Gifu, Japan
- Department of Neurology, Medical University Warsaw, Warsaw, Poland
- Department of Neurology SNUCM, Seoul, South Korea
- Unidad de Parkinson y Trastornos del Movimiento Instituto Clínic de Neurociencias, Hospital Clinic de Barcelona, Barcelona, Catalonia, Spain
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to map and quantify laryngopharyngeal function, meaning swallowing, voice and airway protection, in people with Parkinson's and similar neurodegenerative diseases, so clinicians can better detect aspiration risk and tailor care. Participants get a FEES exam using a validated task protocol, where a thin camera is passed through the nose to watch the larynx and pharynx during specific tasks and swallows, allowing direct observation of secretions, airway closure, and swallow timing. This is observational, it does not change treatments like levodopa, it simply documents how these functions vary across diseases and stages. Adults 18 and older with diagnoses such as Parkinson's, multiple system atrophy, progressive supranuclear palsy, motor neuron disease, or other neurodegenerative disorders are eligible if they completed the FEES protocol and gave consent; Parkinson's cases can be Hoehn and Yahr stage I through V.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 16 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 10 years and 4 months.