Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases

NCT04706234 | Recruiting

• 1 other identifier: S21(a)/2017
• Study Type: observational
• Target: 350
• Locations: 8 countries
• Sites: 16

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 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.

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

Outcome Measures

Primary Outcomes (2)

• 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

  1 day

• dysphagia

  occurrence of dysphagic symptoms when assessed with the task-protocol

  1 day

Other Outcomes (1)

• laryngeal EMG findings

  1 day

Study Arms (5)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited at the participating sites from outpatient's clinics or admitted patients.

You may qualify if:

• 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).

You may not qualify if:

• \- Patients who do not sign the consent form

Sponsors & Collaborators

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

Study Sites (16)

Department of Neurology and Department of ENT, Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Department of Neurology, Medical University of Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Movement Disorders Hospital - Kliniken Beelitz

Beelitz-Heilstätten, Brandenburg, 14547, Germany

RECRUITING

Department of Neurology, Medical School Hannover

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Department of Neurology, University Hospital Münster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Department of Neurology, University Hospital Carl Gustav Carus

Dresden, Saxony, 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

Department of Neurology, Medical University Warsaw

Warsaw, 02-091, Poland

RECRUITING

Department of Neurology SNUCM

Seoul, South Korea

RECRUITING

Unidad de Parkinson y Trastornos del Movimiento Instituto Clínic de Neurociencias, Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 30972002 BACKGROUND

• 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.

  PMID: 32757231 BACKGROUND

• 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.

  PMID: 34773420 BACKGROUND

MeSH Terms

Conditions

Multiple System Atrophy; Parkinson Disease; Supranuclear Palsy, Progressive; Motor Neuron Disease; Neurodegenerative Diseases; Deglutition Disorders

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Parkinsonian Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Florin Gandor, MD

  Movement Disorders Hospital Beelitz-Heilstätten, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florin Gandor, MD

CONTACT

+493320422781; gandor@kliniken-beelitz.de

Tobias Warnecke, MD

CONTACT

tobias.warnecke@klinikum-os.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neurologist

Study Record Dates

• First Submitted: January 9, 2021
• First Posted: January 12, 2021
• Study Start: September 1, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

PL (1); AU (1); IT (1); JP (1); DE (9); KR (1); ES (1); IL (1)