Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases (FEEMSA)

April 7, 2025 updated by: Florin Gandor, MD, Kliniken Beelitz GmbH

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Recruiting
        • Department of Neurology and Department of ENT, Medical University Innsbruck
        • Contact:
        • Contact:
        • 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
      • Hamburg, Germany, 22291
      • Hamburg, Germany, 22307
        • Recruiting
        • Department of Neurology Asklepios Klinik Barmbek
        • Contact:
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89081
    • Brandenburg
      • Beelitz-Heilstätten, Brandenburg, Germany, 14547
        • Recruiting
        • Movement Disorders Hospital - Kliniken Beelitz
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Annemarie Vogel, M.Sc.
        • Sub-Investigator:
          • Georg Ebersbach, MD
    • Niedersachsen
    • Nordrhein-Westfalen
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • Recruiting
        • Department of Neurology, University Hospital Münster
        • Contact:
        • Sub-Investigator:
          • Sigrid Ahring
    • Sachsen
    • Thuringia
      • Stadtroda, Thuringia, Germany, 07646
        • Recruiting
        • Department of Neueology Asklepios Klinik Stadtroda
        • Contact:
      • Stadtroda, Thuringia, Germany
  • Israel
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Department of Neurology, Movement Disorders Unit, Medical Center Tel Aviv
        • Contact:
        • Contact:
  • Italy
  • Japan
      • Gifu, Japan, 501-1194
        • Recruiting
        • Department of Neurology, Gifu University Graduate School of Medicine
        • Contact:
          • Takayoshi Shimohata, MD PhD
        • Contact:
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Department of Neurology SNUCM
        • Contact:
  • Poland
  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Recruiting
        • Unidad de Parkinson y Trastornos del Movimiento Instituto Clínic de Neurociencias, Hospital Clinic de Barcelona
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Isabel Vilaseca, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

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.

Description

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:

- Patients who do not sign the consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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).
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day
dysphagia
Time Frame: 1 day
occurrence of dysphagic symptoms when assessed with the task-protocol
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
laryngeal EMG findings
Time Frame: 1 day
abnormalities recorded on laryngeal EMG showing denervation, dystonic co-activation or myoclonic discharges
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kliniken Beelitz GmbH

Collaborators

University of Bologna
Hannover Medical School
University Hospital Muenster
Seoul National University Hospital
Tel Aviv University
Medical University Innsbruck
University of Ulm
Medical University of Warsaw
Asklepios Kliniken Hamburg GmbH
University of Barcelona
University Hospital Carl Gustav Carus
Klinikum Osnabrück
Gifu University Graduate School of Medicine
Asklepios Fachklinikum Stadtroda

Investigators

  • Principal Investigator: Florin Gandor, MD, Movement Disorders Hospital Beelitz-Heilstätten, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

January 9, 2021

First Submitted That Met QC Criteria

January 9, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S21(a)/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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