Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04706234
Status:
RECRUITING
Last Update Posted:
2023-06-15
First Post:
2021-01-09
Brief Title:
Systematic Assessment of Laryngopharyngeal Function in Patients With MSA PD and 4repeat Tauopathies
Sponsor:
Kliniken Beelitz GmbH
Organization:
Kliniken Beelitz GmbH
Study Overview
Official Title:
Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Multiple System Atrophy Parkinsons Disease and 4repeat Tauopathies
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEEMSA
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 Parkinsons 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 Parkinsons 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 systemsresulting in a clinical presentation of dysautonomia combined with either predominantly parkinsonian MSA-P or cerebellar MSA-C symptoms of varying severityIn 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 439 of MSA patients had clinical symptoms of laryngeal dysfunction 93 showed laryngeal abnormalities during FEES performing the task-protocol 912 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 09 and a specificity of 10
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
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 439 of MSA patients had clinical symptoms of laryngeal dysfunction 93 showed laryngeal abnormalities during FEES performing the task-protocol 912 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 09 and a specificity of 10
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None