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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

16 sites in 8 countries

Germany9 sites, 9 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

    Recruiting

Other trials in Germany

Austria1 site, 1 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

    Recruiting

Other trials in Austria

Israel1 site, 1 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

    Recruiting

Other trials in Israel

Italy1 site, 1 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

    Recruiting

Other trials in Italy

Japan1 site, 1 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

    Recruiting

Other trials in Japan

Poland1 site, 1 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

    Recruiting

Other trials in Poland

South Korea1 site, 1 recruiting
  • Department of Neurology SNUCM

    Seoul

    Kim Han-Joon, MD PhD, movement@snu.ac.kr

    Recruiting

Other trials in South Korea

Spain1 site, 1 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

    Recruiting

Other trials in Spain

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.

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 groups in NCT04706234
Study groupRoleWhat they receive
Multiple System AtrophyPatients 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 palsyPatients 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 DiseasePatients 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 DiseasePatients diagnosed with Motor Neuron Disease that received laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).
Neurodegenerative DiseasesPatients 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.

  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

    Measured: 1 day

  2. 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.

  1. First posted12 Jan 2021
  2. Study start1 Sep 2017
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

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)
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 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

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.

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