About this trial
This is a non-interventional observational study designed to systematically record the results of routine laryngeal examinations and specific characteristics of dysphagia in patients with neurodegenerative disorders. The results of a fiberoptic / flexible endoscopic evaluation of swallowing (FEES) while performing a structured task protocol will be recorded. If available, laryngeal electromyography (EMG) results will also be recorded. In addition to the examination results, demographic and disease-specific data are collected, and two questionnaires, the Swallowing Disturbance Questionnaire for Parkinson's Disease (SDQ-PD) and the swallowing specific Quality Of Life Questionnaire (SWALQOL), are administered.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of probable or possible multiple system atrophy according to current consensus criteria (Gilman et al. 2008) or
diagnosis of probable or possible PSP according to the the Movement Disorders Society (MDS) diagnostic criteria (Höglinger et al. 2017) or
diagnosis of Parkinson's disease according to the MDS diagnostic criteria (Postuma et al 2015)
Hoehn and Yahr Stage within the range of I-V or
Disqualifiers
None
Trial population
Patients will be recruited at the participating sites from outpatient's clinics or admitted patients.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
laryngeal movement disorders
occurrence of vocal fold motion impairment, paradoxical vocal fold motion, vocal fold fixation or involuntary irregular arytenoid cartilages movements when assessed with the task-protocol
dysphagia
occurrence of dysphagic symptoms when assessed with the task-protocol
Other outcomes
laryngeal EMG findings
abnormalities recorded on laryngeal EMG showing denervation, dystonic co-activation or myoclonic discharges
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kliniken Beelitz GmbH
Lead sponsor
University Hospital Muenster
Collaborator
Medical University of Warsaw
Collaborator
Hannover Medical School
Collaborator
University of Ulm
Collaborator
Medical University Innsbruck
Collaborator
University Hospital Carl Gustav Carus
Collaborator
University of Barcelona
Collaborator
Seoul National University Hospital
Collaborator
Gifu University Graduate School of Medicine
Collaborator
University of Bologna
Collaborator
Tel Aviv University
Collaborator
Asklepios Kliniken Hamburg GmbH
Collaborator
Asklepios Fachklinikum Stadtroda
Collaborator
Klinikum Osnabrück
Collaborator