Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies

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Brief Title

Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies

Official Title

Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Multiple System Atrophy, Parkinson's Disease and 4repeat Tauopathies

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 multiple system atrophy (MSA), Parkinson's disease (PD) and progressive
      supranuclear palsy (PSP) and related 4repeat tauopathies. 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

      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.

      The aim of this FEEMSA trial is to continue recruitment of patients with MSA and PD and
      systematically assess laryngopharyngeal function in an even larger cohort. Moreover, patients
      with PSP and related 4repeat tauopathies will also be recruited at eligible sites to compare
      results from this cohort to results in MSA and PD. If available, laryngeal EMG will also be
      recorded.
    


Study Type

Observational


Primary Outcome

laryngeal movement disorders


Condition

Multiple System Atrophy


Study Arms / Comparison Groups

 Multiple System Atrophy
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

200

Start Date

September 1, 2017

Completion Date

July 31, 2023

Primary Completion Date

December 31, 2022

Eligibility Criteria

        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

        Exclusion Criteria:

          -  Patients who do not sign the consent form

          -  Patients who have contraindications for performing fiber endoscopic laryngoscopy and
             swallowing examination.

          -  Pregnancy in female patients
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Florin Gandor, MD, +493320422781, [email protected]

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT04706234

Organization ID

S21(a)/2017


Responsible Party

Principal Investigator

Study Sponsor

Kliniken Beelitz GmbH

Collaborators

 University Hospital Muenster

Study Sponsor

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


Verification Date

September 2021