Parkinson's Trial NCT04706234
Map swallowing and voice function
- Trial ID
- NCT04706234
- Official Title
- Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases
- Goal
- Map swallowing and voice 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
Summary For Families
It aims to map how swallowing and voice box function are affected across several neurodegenerative diseases, because swallowing problems are common and can lead to dehydration, poor nutrition, and pneumonia that shorten life. The team records routine fiberoptic, flexible endoscopic evaluations of swallowing while people perform a structured task, and they also note any available laryngeal muscle testing and have participants fill out two swallowing symptom and quality-of-life questionnaires. Earlier work found that an irregular movement of a small cartilage in the voice box showed up in most people with multiple system atrophy but rarely in Parkinson's, so these exams might help tell those conditions apart. Adults 18 and older with diagnoses such as multiple system atrophy, progressive supranuclear palsy, Parkinson's disease, motor neuron disease, or another neurodegenerative illness who completed the exam protocol and give consent are eligible.
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. It aims to map how swallowing and voice box function are affected across several neurodegenerative diseases, because swallowing problems are common and can lead to dehydration, poor nutrition, and pneumonia that shorten life. The team records routine fiberoptic, flexible endoscopic evaluations of swallowing while people perform a structured task, and they also note any available laryngeal muscle testing and have participants fill out two swallowing symptom and quality-of-life questionnaires. Earlier work found that an irregular movement of a small cartilage in the voice box showed up in most people with multiple system atrophy but rarely in Parkinson's, so these exams might help tell those conditions apart. Adults 18 and older with diagnoses such as multiple system atrophy, progressive supranuclear palsy, Parkinson's disease, motor neuron disease, or another neurodegenerative illness who completed the exam protocol and give consent are eligible.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 10 years and 4 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.