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RecruitingNCT04706234FEEMSAUpdated Apr 9, 2025

Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases

An observational study in Multiple System Atrophy, Parkinson Disease and Progressive Supranuclear Palsy, sponsored by Kliniken Beelitz GmbH. Recruiting at 16 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Kliniken Beelitz GmbH · Observational

From the registry’s dates

  • Started Sep 2017; still recruiting 9 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
350
Ages
18 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

  • 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
03

In context

Multiple System Atrophy

207 studies on the registry are indexed under Multiple System Atrophy; 73 are open to participants now.

This study's planned enrollment of 350 is above the median of 196 across 67 observational studies indexed under Multiple System Atrophy.

Browse Multiple System Atrophy studies →

Lead sponsor

Kliniken Beelitz GmbH is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who do not sign the consent form
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
350 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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).

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 day

  2. dysphagia

    occurrence of dysphagic symptoms when assessed with the task-protocol

    Time frame: 1 day

Other outcomes

  1. laryngeal EMG findings

    abnormalities recorded on laryngeal EMG showing denervation, dystonic co-activation or myoclonic discharges

    Time frame: 1 day

07

Study locations

16 of 16 sites recruiting
  • Department of Neurology and Department of ENT, Medical University Innsbruck
    Innsbruck, Tirol 6020, Austria
    Recruiting
    • Gregor Wenning, MD, PhD, MSc · Contactgregor.wenning@i-med.ac.at · +43676596
    • Alessandra Fanciulli, MD, PhD · ContactAlessandra.Fanciulli@i-med.ac.at · +435125048
    • 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 · Sub investigator
  • Department of Neurology, Medical University of Ulm
    Ulm, Baden-Württemberg 89081, Germany
    Recruiting
  • Movement Disorders Hospital - Kliniken Beelitz
    Beelitz-Heilstätten, Brandenburg 14547, Germany
    Recruiting
  • Department of Neurology, Medical School Hannover
    Hannover, Niedersachsen 30625, Germany
    Recruiting
  • Department of Neurology, University Hospital Münster
    Münster, Nordrhein-Westfalen 48149, Germany
    Recruiting
  • Department of Neurology, University Hospital Carl Gustav Carus
    Dresden, Sachsen 01307, Germany
    Recruiting
  • Department of Neueology Asklepios Klinik Stadtroda
    Stadtroda, Thuringia 07646, Germany
    Recruiting
  • Asklepios Fachklinikum Stadtroda
    Stadtroda, Thuringia, Germany
    Recruiting
  • Asklepios Klinik Barmbek
    Hamburg, 22291, Germany
    Recruiting
  • Department of Neurology Asklepios Klinik Barmbek
    Hamburg, 22307, Germany
    Recruiting
  • Department of Neurology, Movement Disorders Unit, Medical Center Tel Aviv
    Tel Aviv, 64239, Israel
    Recruiting
  • IRCCS Istituto delle Scienze Neurologiche, Azienda USL di Bologna
    Bologna, 40124, Italy
    Recruiting
  • Department of Neurology, Gifu University Graduate School of Medicine
    Gifu, 501-1194, Japan
    Recruiting
    • Takayoshi Shimohata, MD PhD · Contact
    • Kenjiro Kunieda, MD PhD · Contactken2rou.k@gmail.com · +81 58 230 6254
  • Department of Neurology SNUCM
    Seoul, Korea, Republic of
    Recruiting
  • Department of Neurology, Medical University Warsaw
    Warsaw, 02-091, Poland
    Recruiting
  • Unidad de Parkinson y Trastornos del Movimiento Instituto Clínic de Neurociencias, Hospital Clinic de Barcelona
    Barcelona, Catalonia 08036, Spain
    Recruiting
    • Maria J Marti, MD PhD · Contactmjmarti@clinic.cat · +34 93 227 57 85
    • Alexandra Perez, MD · Contactaperez3@clinic.cat · +34 93 227 57 85
    • Isabel Vilaseca, MD · Sub investigator
08

References and documents

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 30972002 ↗
  • 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. PubMed 32757231 ↗
  • 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. PubMed 34773420 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2017 (actual). Primary completion is estimated for Dec 2027, 123 months after the start.

Of 39 observational studies under Multiple System Atrophy, half reached primary completion within 94 months of starting (the median), counting those still running; a quarter within 37. This study's planned 123 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2021
First posted
Jan 12, 2021
StartActual
Sep 1, 2017
Primary completionEst.
Dec 31, 2027
CompletionEst.
Jul 31, 2028
Last update
Apr 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04706234
Lead sponsor
Kliniken Beelitz GmbH
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
Florin Gandor, MD (Consultant Neurologist, Kliniken Beelitz GmbH) — Principal investigator
First posted
Jan 12, 2021
Start date
Sep 1, 2017
Primary completion
Dec 31, 2027 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Apr 9, 2025

Study contacts

Florin Gandor, MD
Contact
gandor@kliniken-beelitz.de
+493320422781 ext. 22781
Tobias Warnecke, MD
Contact
tobias.warnecke@klinikum-os.de
Florin Gandor, MD
principal investigator · Movement Disorders Hospital Beelitz-Heilstätten, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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