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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04706234
Other study ID # S21(a)/2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date July 31, 2024

Study information

Verified date June 2023
Source Kliniken Beelitz GmbH
Contact Florin Gandor, MD
Phone +493320422781
Email gandor@kliniken-beelitz.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 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.


Description:

Multiple system atrophy (MSA) is a sporadic progressive neurodegenerative disorder caused by oligodendroglial aggregation of α-synuclein affecting predominantly the nigrostriatal, olivo-ponto-cerebellar, and autonomic systems,resulting in a clinical presentation of dysautonomia combined with either predominantly parkinsonian (MSA-P) or cerebellar (MSA-C) symptoms of varying severity.In its early stage, the diagnosis of MSA according to the second consensus criteria can be challenging. Therefore, the Movement Disorders Society MSA study group recently addressed the importance of developing valuable diagnostic tools for securing an early diagnosis in patients with MSA not only to estimate disease prognosis but also to early initiate novel, potentially disease-modifying treatments in clinical trials. Despite laryngopharyngeal dysfunction being associated with decreased life expectancy and quality of life, systematic assessment of these functions in MSA is scarce. Previously, an easy-to-implement MSA-FEES task-protocol was suggested to systematically assess laryngopharyngeal function. A pilot study on 8 patients with MSA not only showed that the task protocol was feasible and well tolerated, but also that laryngopharyngeal symptoms where highly prevalent despite the lack of clinical presentation (Warnecke et. al 2019). Moreover, irregular arytenoid cartilages movements where present in all MSA-patients when performing this task protocol, suggesting this symptom could serve as a clinical marker to identify MSA-patients. Following this pilot study, an observational two center study assessed 57 MSA patients with this protocol and compared findings to an age-matched cohort of PD-patients (Gandor et al. 2020). While only 43.9% of MSA patients had clinical symptoms of laryngeal dysfunction, 93% showed laryngeal abnormalities during FEES performing the task-protocol. 91.2% of MSA-patients showed irregular arytenoid cartilages movements. In contrast, only one PD patient showed laryngeal abnormalities with vocal fold motion impairment, but not irregular arytenoid cartilages movements. This study suggests that irregular arytenoid cartilages movements allow differentiating MSA from PD with a sensitivity of 0.9 and a specificity of 1.0. The aim of this FEEMSA trial is to continue recruitment of patients with MSA and PD and systematically assess laryngopharyngeal function in an even larger cohort. Moreover, patients with PSP and related 4repeat tauopathies will also be recruited at eligible sites to compare results from this cohort to results in MSA and PD. If available, laryngeal EMG will also be recorded.


Recruitment information / eligibility

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

Study Design


Locations

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

Sponsors (8)

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

Countries where clinical trial is conducted

Austria,  Germany,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  Spain, 

References & Publications (3)

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

Outcome

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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