NCT04706234 Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases
| NCT ID | NCT04706234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kliniken Beelitz GmbH |
| Condition | Multiple System Atrophy |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2017-09-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2017-09-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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
Contact & Investigator
Florin Gandor, MD
PRINCIPAL INVESTIGATOR
Movement Disorders Hospital Beelitz-Heilstätten, Germany
Frequently Asked Questions
Who can join the NCT04706234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple System Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04706234 currently recruiting?
Yes, NCT04706234 is actively recruiting participants. Contact the research team at gandor@kliniken-beelitz.de for enrollment information.
Where is the NCT04706234 trial being conducted?
This trial is being conducted at Innsbruck, Austria, Ulm, Germany, Beelitz-Heilstätten, Germany, Hanover, Germany and 11 additional locations.
Who is sponsoring the NCT04706234 clinical trial?
NCT04706234 is sponsored by Kliniken Beelitz GmbH. The principal investigator is Florin Gandor, MD at Movement Disorders Hospital Beelitz-Heilstätten, Germany. The trial plans to enroll 350 participants.