Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases
- Sponsor
- Kliniken Beelitz GmbH
- Study ID
- NCT04706234
- Status
- Recruiting
Conditions
- Motor Neuron Disease
- Multiple System Atrophy
- Neurodegenerative Diseases
- Parkinson Disease
- Progressive Supranuclear Palsy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- First listed
- Jan 12, 2021
- Start date
- Sep 1, 2017
- Status verified
- Apr 2025
- Primary completion
- Dec 31, 2027
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 350 participants (estimated)
Arms
- Arm: Multiple System AtrophyPatients diagnosed will probable or possible MSA according to the 2nd criteria for the diagnosis of MSA (Gilman 2008) that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).
- Arm: progressive supranuclear palsyPatients diagnosed will probable or possible Progressive Supranuclear Palsy or (PSP) related 4repeat tauopathies according to the Movement Disorders Society diagnostic criteria (Höglinger 2017) that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).
- Arm: Parkinson DiseasePatients diagnosed will Parkinson's disease according to the Movement Disorders Society diagnostic criteria (Postuma 2015) that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).
- Arm: Motor Neuron DiseasePatients diagnosed with Motor Neuron Disease that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).
- Arm: Neurodegenerative DiseasesPatients diagnosed with a neurodegenerative disease not specified above that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).
Primary Outcome Measure
laryngeal movement disorders [ Time Frame: 1 day ]
Central Contacts
- Florin Gandor, MD+493320422781
- Tobias Warnecke, MD
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