Parkinson Disease Clinical Trial
— FEEMSAOfficial title:
Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Multiple System Atrophy, Parkinson's Disease and 4repeat Tauopathies
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 multiple system atrophy (MSA), Parkinson's disease (PD) and progressive supranuclear palsy (PSP) and related 4repeat tauopathies. 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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | July 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 Exclusion Criteria: - Patients who do not sign the consent form - Patients who have contraindications for performing fiber endoscopic laryngoscopy and swallowing examination. - Pregnancy in female patients |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Neurology and Department of ENT, Medical University Innsbruck | Innsbruck | Tirol |
Germany | Movement Disorders Hospital - Kliniken Beelitz | Beelitz-Heilstätten | Brandenburg |
Germany | Department of Neurology, University Hospital Carl Gustav Carus | Dresden | Sachsen |
Germany | Asklepios Klinik Barmbek | Hamburg | |
Germany | Department of Neurology Asklepios Klinik Barmbek | Hamburg | |
Germany | Department of Neurology, Medical School Hannover | Hannover | Niedersachsen |
Germany | Department of Neurology, University Hospital Münster | Münster | Nordrhein-Westfalen |
Germany | Asklepios Fachklinikum Stadtroda | Stadtroda | Thuringia |
Germany | Department of Neueology Asklepios Klinik Stadtroda | Stadtroda | Thuringia |
Germany | Department of Neurology, Medical University of Ulm | Ulm | Baden-Württemberg |
Israel | Department of Neurology, Movement Disorders Unit, Medical Center Tel Aviv | Tel Aviv | |
Italy | IRCCS Istituto delle Scienze Neurologiche, Azienda USL di Bologna | Bologna | |
Japan | Department of Neurology, Gifu University Graduate School of Medicine | Gifu | |
Korea, Republic of | Department of Neurology SNUCM | Seoul | |
Poland | Department of Neurology, Medical University Warsaw | Warsaw | |
Spain | Unidad de Parkinson y Trastornos del Movimiento Instituto Clínic de Neurociencias, Hospital Clinic de Barcelona | Barcelona | Catalonia |
Lead Sponsor | Collaborator |
---|---|
Kliniken Beelitz GmbH | Hannover Medical School, Medical University Innsbruck, Medical University of Warsaw, University Hospital Carl Gustav Carus, University Hospital Muenster, University of Barcelona, University of Ulm |
Austria, Germany, Israel, Italy, Japan, Korea, Republic of, Poland, Spain,
Gandor F, Vogel A, Claus I, Ahring S, Gruber D, Heinze HJ, Dziewas R, Ebersbach G, Warnecke T. Laryngeal Movement Disorders in Multiple System Atrophy: A Diagnostic Biomarker? Mov Disord. 2020 Dec;35(12):2174-2183. doi: 10.1002/mds.28220. Epub 2020 Aug 5. — View Citation
Vogel A, Claus I, Ahring S, Gruber D, Haghikia A, Frank U, Dziewas R, Ebersbach G, Gandor F, Warnecke T. Endoscopic Characteristics of Dysphagia in Multiple System Atrophy Compared to Parkinson's Disease. Mov Disord. 2022 Mar;37(3):535-544. doi: 10.1002/mds.28854. Epub 2021 Nov 13. — View Citation
Warnecke T, Vogel A, Ahring S, Gruber D, Heinze HJ, Dziewas R, Ebersbach G, Gandor F. The Shaking Palsy of the Larynx-Potential Biomarker for Multiple System Atrophy: A Pilot Study and Literature Review. Front Neurol. 2019 Mar 26;10:241. doi: 10.3389/fneur.2019.00241. eCollection 2019. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | laryngeal EMG findings | abnormalities recorded on laryngeal EMG showing denervation, dystonic co-activation or myoclonic discharges | 1 day | |
Primary | 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 | 1 day | |
Primary | dysphagia | occurrence of dysphagic symptoms when assessed with the task-protocol | 1 day |
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