Multiple System AtrophyFEEMSANCT04706234
Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases
An observational study of Multiple System Atrophy and Parkinson Disease, run by Kliniken Beelitz GmbH at 16 sites in 8 countries.
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 neurodegenerative disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple System Atrophy, Parkinson Disease, Progressive Supranuclear Palsy
- How many people
- 350 participants
- Where
- 16 sitesin 8 countries
- Study dates
- 1 Sep 2017to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited at the participating sites from outpatient's clinics or admitted patients.
Who may be able to join
- 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).
Who cannot join
- Patients who do not sign the consent form
Trial locations and contacts
16 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Tobias Warnecke, MD contact
16 sites in 8 countries
Germany9 sites, 9 recruiting
- Recruiting
Movement Disorders Hospital - Kliniken Beelitz
Beelitz-Heilstätten, Brandenburg, 14547
Florin Gandor, MD, +49332042 ext. 2781, gandor@kliniken-beelitz.de
Doreen Gruber, MD, +49332042 ext. 2781, gruber@kliniken-beelitz.de
- Recruiting
Department of Neurology, University Hospital Carl Gustav Carus
Dresden, Saxony, 01307
Björn Falkenburger, MD, +49351458 ext. 2532, Bjoern.Falkenburger@dzne.de
Inaki Schniewind, MD, Inaki.Schniewind@uniklinikum-dresden.de
- Recruiting
Asklepios Klinik Barmbek
Hamburg, 22291
Peter P Urban, Prof., c.herborn@asklepios.com
- Recruiting
Department of Neurology Asklepios Klinik Barmbek
Hamburg, 22307
Peter Urban, MD, 0401818823841, p.urban@asklepios.com
- Recruiting
Department of Neurology, Medical School Hannover
Hanover, Lower Saxony, 30625
Martin Klietz, MD, martin.klietz@mh-hannover.de
Katharina Pannewitz-Makaj, MD, Pannewitz-Makaj.Katharina@mh-hannover.de
- Recruiting
Department of Neurology, University Hospital Münster
Münster, North Rhine-Westphalia, 48149
Inga Claus, MD, inga.claus@ukmuenster.de
Sigrid Ahring
- Recruiting
Department of Neueology Asklepios Klinik Stadtroda
Stadtroda, Thuringia, 07646
David Weise, +49 36428 56 ext. 1375, mailto:da.weise@asklepios.com
- Recruiting
Asklepios Fachklinikum Stadtroda
Stadtroda, Thuringia
David Weise, PD Dr, da.weise@asklepios.com
- Recruiting
Department of Neurology, Medical University of Ulm
Ulm, Baden-Wurttemberg, 89081
Jan Kassubek, MD, jan.kassubek@uni-ulm.de
Rebecca Kassubek, MD, rebecca.kassubek@uni-ulm.de
Austria1 site, 1 recruiting
- Recruiting
Department of Neurology and Department of ENT, Medical University Innsbruck
Innsbruck, Tyrol, 6020
Gregor Wenning, MD, PhD, MSc, +43676596 ext. 4772, gregor.wenning@i-med.ac.at
Alessandra Fanciulli, MD, PhD, +435125048 ext. 3238, Alessandra.Fanciulli@i-med.ac.at
Israel1 site, 1 recruiting
- Recruiting
Department of Neurology, Movement Disorders Unit, Medical Center Tel Aviv
Tel Aviv, 64239
Tanya Gurevich, MD, tanyag@tlvmc.gov.il
Adi Ezra, adil@tlvmc.gov.il
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto delle Scienze Neurologiche, Azienda USL di Bologna
Bologna, 40124
Giulia Giannini, MD, PhD, giulia.giannini15@unibo.it
Luca Baldelli, MD, luca.baldelli4@unibo.it
Japan1 site, 1 recruiting
- Recruiting
Department of Neurology, Gifu University Graduate School of Medicine
Gifu, 501-1194
Takayoshi Shimohata, MD PhD
Kenjiro Kunieda, MD PhD, +81 58 230 6254, ken2rou.k@gmail.com
Poland1 site, 1 recruiting
- Recruiting
Department of Neurology, Medical University Warsaw
Warsaw, 02-091
Andrzej Friedman, MD, PhD, andrzej.friedman@wum.edu.pl
Natalia Madetko, MD, natalia.madetko@wum.edu.pl
South Korea1 site, 1 recruiting
- Recruiting
Department of Neurology SNUCM
Seoul
Kim Han-Joon, MD PhD, movement@snu.ac.kr
Spain1 site, 1 recruiting
- Recruiting
Unidad de Parkinson y Trastornos del Movimiento Instituto Clínic de Neurociencias, Hospital Clinic de Barcelona
Barcelona, Catalonia, 08036
Maria J Marti, MD PhD, +34 93 227 57 85, mjmarti@clinic.cat
Alexandra Perez, MD, +34 93 227 57 85, aperez3@clinic.cat
About this study
Official title: Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases
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.
Read the detailed description
Neurodegenerative disorders are associated with a high prevalence of neurogenic dysphagia. Depending on the underlying disease, the prevalence can affect up to 80% of patients. Dysphagia is associated with dehydration, malnutrition, facilitates aspiration pneumonia and thereby determines the prognosis of neurodegenerative diseases. For most of them, dysphagia-associated complications are the leading cause of death.
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.
4repeat tauopathies (4RT) are caused by an intraneuronal accumulation of 4repeat tau.
4RT, also known as progressive supranuclear palsy (PSP) with all its clinical subtypes, is a rapidly progressive neurodegenerative disease that leads to increasing impairment of cortical and subcortical function in the affected person due to the accumulation of tau protein in the brain (Höglinger 2017). Due to the clinical variability of the presentation, early diagnostic certainty is desirable. Depending on the affected area in the central nervous system, different clinical phenotypes result. The most commonly described and researched entity is Progressive Supranuclear P, also known as Richardson Syndrome, or PSP-RS. Further clinical presentations include a Parkinsonian variant (PSP-P), corticobasal syndrome (PSP-CBS), pure akinesia with gait freezing (PSP-PAGF), speech/language dominant presentations (PSP-SL), frontotemproal dementia variants (PSP-FTD), and cerebellar presentations (PSP-C) (Höglinger 2017).
4RT is also associated with swallowing and speech problems, and aspiration pneumonia is one of the most common causes of death in this disease entity (Tilley 2016). In addition, dystonic dysinnervation of laryngeal muscles can lead to laryngeal motion abnormalities (Panegyres 2007).
Equally, patients with motor neurone disease (MND) are affected by dysphagia early in the disease. In a FEES study by Steven B. Leder and colleagues (2004), which included 17 ALS patients subjectively complaining of dysphagia, fluid aspiration or an increased risk of fluid aspiration was found in almost 60% of cases, regardless of whether the disease initially mainly affected the bulbar musculature or the limb musculature. As the disease progressed, the depth of penetration of fluids into the hypopharynx prior to triggering the swallowing reflex increased, so these patients were advised to thicken fluids. Initially, residues of solid food consistencies were detected in the valleculae, piriform sinus and/or laryngeal inlet in three patients after swallowing. As a result of progressive paresis of the pharyngeal muscles, the residuals increased in the ALS patients examined during the course of the disease. If this disorder pattern was detected, it was advised to reduce the size of the food bolus and to clear the pharynx by swallowing water or reswallowing several times. In a further small case series (n = 11), the FEES showed that dysphagic ALS patients are particularly at risk of penetration/aspiration when swallowing liquids. Penetration and aspiration occur particularly frequently intradeglutitively (D'Ottaviano et al. 2013). A recent publication reports on FEES examinations in 202 ALS patients (w/m 95/107; bulbar/spinal onset 66/136; mean age 64.68 +/- 11.12 years). A close positive correlation with disease severity (measured using the ALSFRS-R) was found for all FEES parameters (leaking, aspiration, residuals), regardless of the three consistencies tested (liquid, semi-solid, solid) (Fattori et al. 2017).
The aim of this FEEMSA trial is to continue recruitment of patients with neurodegenerative diseases and systematically assess laryngopharyngeal function in large cohorts, to categorise the dysphagia phenotypes and better correlate them with the disease subtypes (MSA Parkinson vs cerebellar; PSP variants, MND variants, etc). If available, laryngeal EMG will also be recorded.
- Conditions
- Multiple System Atrophy, Parkinson Disease, Progressive Supranuclear Palsy, Motor Neuron Disease, Neurodegenerative Diseases
- Keywords
- Multiple System Atrophy, Progressive Supranuclear Palsy, Parkinson's disease, Motor Neuron Disease, Neurodegenerative Diseases, Dysphagia, FEES, Laryngeal EMG, Irregular Arytenoid Cartilages Movements, Clinical Biomarker
- Medical subject headings
- Multiple System Atrophy, Parkinson Disease, Supranuclear Palsy, Progressive, Motor Neuron Disease, Neurodegenerative Diseases, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). | |
| Motor Neuron Disease | Patients diagnosed with Motor Neuron Disease that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019). | |
| Neurodegenerative Diseases | Patients diagnosed with a neurodegenerative disease not specified above that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
dysphagia
occurrence of dysphagic symptoms when assessed with the task-protocol
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Sep 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Beelitz GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Muenster, Medical University of Warsaw, Hannover Medical School, University of Ulm, Medical University Innsbruck, University Hospital Carl Gustav Carus, University of Barcelona, Seoul National University Hospital, Gifu University Graduate School of Medicine, University of Bologna, Tel Aviv University, Asklepios Kliniken Hamburg GmbH, Asklepios Fachklinikum Stadtroda, Klinikum Osnabrück
- Responsible party
- Principal investigator, Florin Gandor, MD, Kliniken Beelitz GmbH
- Investigators
- Florin Gandor, MD, Principal investigator, Movement Disorders Hospital Beelitz-Heilstätten, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706234
- Sponsor's protocol ID
- S21(a)/2017
- Acronym
- FEEMSA
- Status last verified
- Apr 2025
- First submitted
- 9 Jan 2021
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30972002Gandor 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.
PubMed 32757231Vogel 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.
PubMed 34773420
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT04706234
- Acronym / sponsor ID
- FEEMSA / S21(a)/2017
- Conditions
- Multiple System Atrophy, Parkinson Disease, Progressive Supranuclear Palsy, Motor Neuron Disease, Neurodegenerative Diseases
- Keywords
- Multiple System Atrophy, Progressive Supranuclear Palsy, Parkinson's disease, Motor Neuron Disease, Neurodegenerative Diseases, Dysphagia, FEES, Laryngeal EMG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Kliniken Beelitz GmbHUniversity, hospital or other
- Collaborators
- University Hospital Muenster, Medical University of Warsaw, Hannover Medical School, University of Ulm, Medical University Innsbruck, University Hospital Carl Gustav Carus, University of Barcelona, Seoul National University Hospital, Gifu University Graduate School of Medicine, University of Bologna, Tel Aviv University, Asklepios Kliniken Hamburg GmbH, Asklepios Fachklinikum Stadtroda, Klinikum Osnabrück
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neurodegenerative disorders are associated with a high prevalence of neurogenic dysphagia. Depending on the underlying disease, the prevalence can affect up to 80% of patients. Dysphagia is associated with dehydration, malnutrition, facilitates aspiration pneumonia and thereby determines the prognosis of neurodegenerative diseases. For most of them, dysphagia-associated complications are the leading cause of death.
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.
4repeat tauopathies (4RT) are caused by an intraneuronal accumulation of 4repeat tau.
4RT, also known as progressive supranuclear palsy (PSP) with all its clinical subtypes, is a rapidly progressive neurodegenerative disease that leads to increasing impairment of cortical and subcortical function in the affected person due to the accumulation of tau protein in the brain (Höglinger 2017). Due to the clinical variability of the presentation, early diagnostic certainty is desirable. Depending on the affected area in the central nervous system, different clinical phenotypes result. The most commonly described and researched entity is Progressive Supranuclear P, also known as Richardson Syndrome, or PSP-RS. Further clinical presentations include a Parkinsonian variant (PSP-P), corticobasal syndrome (PSP-CBS), pure akinesia with gait freezing (PSP-PAGF), speech/language dominant presentations (PSP-SL), frontotemproal dementia variants (PSP-FTD), and cerebellar presentations (PSP-C) (Höglinger 2017).
4RT is also associated with swallowing and speech problems, and aspiration pneumonia is one of the most common causes of death in this disease entity (Tilley 2016). In addition, dystonic dysinnervation of laryngeal muscles can lead to laryngeal motion abnormalities (Panegyres 2007).
Equally, patients with motor neurone disease (MND) are affected by dysphagia early in the disease. In a FEES study by Steven B. Leder and colleagues (2004), which included 17 ALS patients subjectively complaining of dysphagia, fluid aspiration or an increased risk of fluid aspiration was found in almost 60% of cases, regardless of whether the disease initially mainly affected the bulbar musculature or the limb musculature. As the disease progressed, the depth of penetration of fluids into the hypopharynx prior to triggering the swallowing reflex increased, so these patients were advised to thicken fluids. Initially, residues of solid food consistencies were detected in the valleculae, piriform sinus and/or laryngeal inlet in three patients after swallowing. As a result of progressive paresis of the pharyngeal muscles, the residuals increased in the ALS patients examined during the course of the disease. If this disorder pattern was detected, it was advised to reduce the size of the food bolus and to clear the pharynx by swallowing water or reswallowing several times. In a further small case series (n = 11), the FEES showed that dysphagic ALS patients are particularly at risk of penetration/aspiration when swallowing liquids. Penetration and aspiration occur particularly frequently intradeglutitively (D'Ottaviano et al. 2013). A recent publication reports on FEES examinations in 202 ALS patients (w/m 95/107; bulbar/spinal onset 66/136; mean age 64.68 +/- 11.12 years). A close positive correlation with disease severity (measured using the ALSFRS-R) was found for all FEES parameters (leaking, aspiration, residuals), regardless of the three consistencies tested (liquid, semi-solid, solid) (Fattori et al. 2017).
The aim of this FEEMSA trial is to continue recruitment of patients with neurodegenerative diseases and systematically assess laryngopharyngeal function in large cohorts, to categorise the dysphagia phenotypes and better correlate them with the disease subtypes (MSA Parkinson vs cerebellar; PSP variants, MND variants, etc). If available, laryngeal EMG will also be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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). |
| Motor Neuron Disease | – | –Patients diagnosed with Motor Neuron Disease that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019). |
| Neurodegenerative Diseases | – | –Patients diagnosed with a neurodegenerative disease not specified above that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited at the participating sites from outpatient's clinics or admitted patients.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who do not sign the consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
dysphagia
Time frame: 1 day
occurrence of dysphagic symptoms when assessed with the task-protocol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 30972002Warnecke 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.
- Background: PubMed 32757231Gandor 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.
- Background: PubMed 34773420Vogel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tobias Warnecke, MD contact
Florin Gandor, MD principal investigator
Movement Disorders Hospital Beelitz-Heilstätten, Germany
16 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple System Atrophy and Parkinson Disease, run by Kliniken Beelitz GmbH at 16 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Austria, Israel, Italy, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florin Gandor, MD (+493320422781 ext. 22781, gandor@kliniken-beelitz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laryngeal movement disorders (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04706234, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.