Assessing swallowing function in patients with neurodegenerative diseases
Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases
Kliniken Beelitz GmbH · NCT04706234
This study looks at how well people with neurodegenerative diseases, like Parkinson's and Motor Neuron Disease, can swallow and how it affects their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kliniken Beelitz GmbH (other) |
| Locations | 16 sites (Innsbruck, Tyrol and 15 other locations) |
| Trial ID | NCT04706234 on ClinicalTrials.gov |
What this trial studies
This observational study systematically records the results of routine laryngeal examinations and specific characteristics of dysphagia in patients diagnosed with neurodegenerative disorders such as Multiple System Atrophy, Parkinson's Disease, and Motor Neuron Disease. It utilizes fiberoptic endoscopic evaluation of swallowing (FEES) and collects demographic and disease-specific data, along with administering two questionnaires related to swallowing disturbances and quality of life. The study aims to enhance understanding of laryngopharyngeal dysfunction and its implications for patient prognosis and treatment.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with Multiple System Atrophy, Progressive Supranuclear Palsy, Parkinson's Disease, Motor Neuron Disease, or other neurodegenerative diseases who have undergone laryngopharyngeal assessment.
Not a fit: Patients who do not consent to participate in the study will not benefit from its findings.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and early interventions for dysphagia in patients with neurodegenerative diseases.
How similar studies have performed: While the systematic assessment of laryngopharyngeal function in neurodegenerative diseases is not extensively studied, the approach aligns with emerging diagnostic needs in the field, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Innsbruck, Tyrol and 15 other locations
- Department of Neurology and Department of ENT, Medical University Innsbruck — Innsbruck, Tyrol, Austria (RECRUITING)
- Department of Neurology, Medical University of Ulm — Ulm, Baden-Wurttemberg, Germany (RECRUITING)
- Movement Disorders Hospital - Kliniken Beelitz — Beelitz-Heilstätten, Brandenburg, Germany (RECRUITING)
- Department of Neurology, Medical School Hannover — Hanover, Lower Saxony, Germany (RECRUITING)
- Department of Neurology, University Hospital Münster — Münster, North Rhine-Westphalia, Germany (RECRUITING)
- Department of Neurology, University Hospital Carl Gustav Carus — Dresden, Saxony, Germany (RECRUITING)
- Department of Neueology Asklepios Klinik Stadtroda — Stadtroda, Thuringia, Germany (RECRUITING)
- Asklepios Fachklinikum Stadtroda — Stadtroda, Thuringia, Germany (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, Spain (RECRUITING)
Study contacts
- Principal investigator: Florin Gandor, MD — Movement Disorders Hospital Beelitz-Heilstätten, Germany
- Study coordinator: Florin Gandor, MD
- Email: gandor@kliniken-beelitz.de
- Phone: +493320422781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple System Atrophy, Parkinson Disease, Progressive Supranuclear Palsy, Motor Neuron Disease, Neurodegenerative Diseases, Parkinson's disease, Dysphagia, FEES