Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases

NCT04706234 · tracked via the Priya Life Science Poland tracker

Sponsor

Kliniken Beelitz GmbH

Phase

Observational

Started

2017-09-01

Last updated

2025-04-09

Condition(s) studied

Multiple System AtrophyParkinson DiseaseProgressive Supranuclear PalsyMotor Neuron DiseaseNeurodegenerative Diseases

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 * diagnosis of motor neurone disease or * diagnosis of a neurodegenerative disease other than specified above AND underwent laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019). Exclusion Criteria: \- Patients who do not sign the consent form

Primary outcome measure(s)

laryngeal movement disorders — 1 day
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 — 1 day
occurrence of dysphagic symptoms when assessed with the task-protocol

Trial sites (16)

Facility	City	Region	Status
Department of Neurology and Department of ENT, Medical University Innsbruck	Innsbruck	Tyrol	Recruiting
Department of Neurology, Medical University of Ulm	Ulm	Baden-Wurttemberg	Recruiting
Movement Disorders Hospital - Kliniken Beelitz	Beelitz-Heilstätten	Brandenburg	Recruiting
Department of Neurology, Medical School Hannover	Hanover	Lower Saxony	Recruiting
Department of Neurology, University Hospital Münster	Münster	North Rhine-Westphalia	Recruiting
Department of Neurology, University Hospital Carl Gustav Carus	Dresden	Saxony	Recruiting
Department of Neueology Asklepios Klinik Stadtroda	Stadtroda	Thuringia	Recruiting
Asklepios Fachklinikum Stadtroda	Stadtroda	Thuringia	Recruiting
Asklepios Klinik Barmbek	Hamburg	Germany	Recruiting
Department of Neurology Asklepios Klinik Barmbek	Hamburg	Germany	Recruiting
Department of Neurology, Movement Disorders Unit, Medical Center Tel Aviv	Tel Aviv	Israel	Recruiting
IRCCS Istituto delle Scienze Neurologiche, Azienda USL di Bologna	Bologna	Italy	Recruiting
Department of Neurology, Gifu University Graduate School of Medicine	Gifu	Japan	Recruiting
Department of Neurology, Medical University Warsaw	Warsaw	Poland	Recruiting
Department of Neurology SNUCM	Seoul	South Korea	Recruiting
Unidad de Parkinson y Trastornos del Movimiento Instituto Clínic de Neurociencias, Hospital Clinic de Barcelona	Barcelona	Catalonia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04706234 on ClinicalTrials.gov ↗ ← All trials in Poland