Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies (FEEMSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04706234
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : September 22, 2021
Sponsor:
Collaborators:
University Hospital Muenster
Medical University of Warsaw
University Hospital Carl Gustav Carus
University of Ulm
Medical University Innsbruck
Hannover Medical School
University of Barcelona
Information provided by (Responsible Party):
Dr. Florin Gandor, MD, Kliniken Beelitz GmbH

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Multiple System Atrophy Parkinson Disease Progressive Supranuclear Palsy

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Multiple System Atrophy, Parkinson's Disease and 4repeat Tauopathies
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Multiple System Atrophy
Patients 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).
progressive supranuclear palsy
Patients 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).
Parkinson Disease
Patients 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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. laryngeal movement disorders [ Time Frame: 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

  2. dysphagia [ Time Frame: 1 day ]
    occurrence of dysphagic symptoms when assessed with the task-protocol


Other Outcome Measures:
  1. laryngeal EMG findings [ Time Frame: 1 day ]
    abnormalities recorded on laryngeal EMG showing denervation, dystonic co-activation or myoclonic discharges


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited at the participating sites from outpatient's clinics or admitted patients.
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

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706234


Contacts
Layout table for location contacts
Contact: Florin Gandor, MD +493320422781 ext 22781 gandor@kliniken-beelitz.de
Contact: Tobias Warnecke, MD +49251980 ext 2902 tobias.warnecke@ukmuenster.de

Locations
Layout table for location information
Austria
Department of Neurology and Department of ENT, Medical University Innsbruck Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Gregor Wenning, MD, PhD, MSc    +43676596 ext 4772    gregor.wenning@i-med.ac.at   
Contact: Alessandra Fanciulli, MD, PhD    +435125048 ext 3238    Alessandra.Fanciulli@i-med.ac.at   
Sub-Investigator: Klaus Seppi, MD, PhD         
Sub-Investigator: Claus Pototschnig, MD, MSc         
Sub-Investigator: Florian Krismer, MD         
Sub-Investigator: Oliver Galvan, MD         
Sub-Investigator: Fabian Leys, MD         
Sub-Investigator: Cecilia Raccagni, MD         
Sub-Investigator: Victoria Sideroff, MD         
Sub-Investigator: Roberta Granata, MD         
Germany
Department of Neurology, Medical University of Ulm Recruiting
Ulm, Baden-Württemberg, Germany, 89081
Contact: Jan Kassubek, MD       jan.kassubek@uni-ulm.de   
Contact: Rebecca Kassubek, MD       rebecca.kassubek@uni-ulm.de   
Sub-Investigator: Beate Lindner-Pfleghar, M.Sc.         
Movement Disorders Hospital - Kliniken Beelitz Recruiting
Beelitz-Heilstätten, Brandenburg, Germany, 14547
Contact: Florin Gandor, MD    +49332042 ext 2781    gandor@kliniken-beelitz.de   
Contact: Doreen Gruber, MD    +49332042 ext 2781    gruber@kliniken-beelitz.de   
Sub-Investigator: Annemarie Vogel, M.Sc.         
Sub-Investigator: Georg Ebersbach, MD         
Department of Neurology, Medical School Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Günter Höglinger, MD       hoeglinger.guenter@mh-hannover.de   
Contact: Katharina Pannewitz-Makaj, MD       Pannewitz-Makaj.Katharina@mh-hannover.de   
Sub-Investigator: Christoph Schrader, MD         
Department of Neurology, University Hospital Münster Recruiting
Münster, Nordrhein-Westfalen, Germany, 48149
Contact: Tobias Warnecke, MD    +49251834 ext 8216    tobias.warnecke@ukmuenster.de   
Contact: Inga Claus, MD       inga.claus@ukmuenster.de   
Sub-Investigator: Sigrid Ahring         
Department of Neurology, University Hospital Carl Gustav Carus Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Björn Falkenburger, MD    +49351458 ext 2532    Bjoern.Falkenburger@dzne.de   
Contact: Inaki Schniewind, MD       Inaki.Schniewind@uniklinikum-dresden.de   
Israel
Department of Neurology, Movement Disorders Unit, Medical Center Tel Aviv Recruiting
Tel Aviv, Israel, 64239
Contact: Tanya Gurevich, MD       tanyag@tlvmc.gov.il   
Contact: Adi Ezra       adil@tlvmc.gov.il   
Italy
IRCCS Istituto delle Scienze Neurologiche, Azienda USL di Bologna Recruiting
Bologna, Italy, 40124
Contact: Giulia Giannini, MD, PhD       giulia.giannini15@unibo.it   
Contact: Luca Baldelli, MD       luca.baldelli4@unibo.it   
Poland
Department of Neurology, Medical University Warsaw Recruiting
Warsaw, Poland, 02-091
Contact: Andrzej Friedman, MD, PhD       andrzej.friedman@wum.edu.pl   
Contact: Natalia Madetko, MD       natalia.madetko@wum.edu.pl   
Spain
Unidad de Parkinson y Trastornos del Movimiento Instituto Clínic de Neurociencias, Hospital Clinic de Barcelona Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Maria J Marti, MD PhD    +34 93 227 57 85    mjmarti@clinic.cat   
Contact: Alexandra Perez, MD    +34 93 227 57 85    aperez3@clinic.cat   
Sub-Investigator: Isabel Vilaseca, MD         
Sponsors and Collaborators
Kliniken Beelitz GmbH
University Hospital Muenster
Medical University of Warsaw
University Hospital Carl Gustav Carus
University of Ulm
Medical University Innsbruck
Hannover Medical School
University of Barcelona
Investigators
Layout table for investigator information
Principal Investigator: Florin Gandor, MD Movement Disorders Hospital Beelitz-Heilstätten, Germany
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Dr. Florin Gandor, MD, Consultant Neurologist, Kliniken Beelitz GmbH
ClinicalTrials.gov Identifier: NCT04706234    
Other Study ID Numbers: S21(a)/2017
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Florin Gandor, MD, Kliniken Beelitz GmbH:
Multiple System Atrophy
Progressive Supranuclear Palsy
Parkinson's disease
clinical biomarker
 FEES
laryngeal EMG
irregular arytenoid cartilages movements
dysphagia
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Supranuclear Palsy, Progressive
Tauopathies
Atrophy
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
 Neurodegenerative Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Paralysis
Neurologic Manifestations
Eye Diseases