Biological Determinants and Neural Compensation of Dysphagia in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf
About this trial
Parkinson's disease (PD) is the second most common neurodegenerative disorder and frequently leads to oropharyngeal dysphagia, a swallowing disorder that strongly affects patient health and quality of life. Dysphagia in PD is associated with aspiration pneumonia, malnutrition, and impaired medication intake, which together represent one of the leading causes of morbidity and premature mortality in these patients. Despite its clinical relevance, the underlying biological mechanisms of dysphagia in PD are not fully understood, and current treatment strategies are limited.
The purpose of this study is to investigate the clinical, biological, and neural determinants of oropharyngeal dysphagia in patients with PD, and to explore compensatory mechanisms of the brain that may counteract swallowing difficulties. We hypothesize that dysphagia in PD is linked not only to disease severity and progression but also to specific biological markers and neural plasticity in the swallowing network.
This is a prospective, cross-sectional observational study including 100 patients with PD. Swallowing function will be systematically assessed using flexible endoscopic evaluation of swallowing (FEES), a gold standard method for detecting penetration and aspiration. Additional clinical data will be collected, including motor and non-motor symptoms, disease severity, and quality of life measures. Biological assessments will include blood-based biomarkers related to inflammation and neurodegeneration. Furthermore, functional magnetic resonance imaging (fMRI) will be used to examine cortical and subcortical activity patterns associated with swallowing and to identify potential compensatory activation in dysphagic and non-dysphagic patients.
By integrating clinical, biological, and imaging approaches, this study aims to provide a comprehensive characterization of dysphagia in PD. The findings are expected to improve the understanding of disease mechanisms and to identify predictors of dysphagia onset and severity. Ultimately, this knowledge may help to guide the development of targeted therapeutic strategies, reduce the risk of severe complications, and improve quality of life for patients with Parkinson's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participation possible in all disease stages, regardless of the presence or absence of subjective or objective oropharyngeal dysphagia
Cognitive ability sufficient to comply with the study paradigm
Daily oral intake of food and fluids (exclusion of patients with exclusive tube feeding)
Disqualifiers
Presence of other conditions associated with oropharyngeal dysphagia, such as stroke, head and neck cancer, neuroinflammatory diseases, neuromuscular disorders, or other brain injuries
Presence of electronic stimulation devices (e.g., pacemaker, deep brain stimulation) or other contraindications for MRI imaging
Diagnosis of asthma or COPD (due to performance of the cough reflex test in "Block 1: Assessment of OD and pharyngeal hyposensitivity")
Trial population
The study population consists of patients diagnosed with idiopathic Parkinson's disease according to the MDS diagnostic criteria (Postuma et al., 2015). Participants may be included in any stage of the disease, provided they are cognitively able to follow the study paradigm and are able to take food and liquids orally. Patients with exclusive tube feeding, comorbid conditions associated with oropharyngeal dysphagia (e.g., stroke, head and neck cancer, neuromuscular disorders), contraindications for MRI, or chronic pulmonary diseases such as asthma or COPD are excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Parkinson's Disease Patients with Dysphagia
Trial outcomes
Primary outcomes
1
Dysphagia Severity assessed by Dynamic Imaging Grade of Swallowing Toxicity-Fiberoptic Endoscopic Evaluation of Swallowing (DIGEST-FEES)
Swallowing safety and efficiency will be assessed using the Dynamic Imaging Grade of Swallowing Toxicity-Fiberoptic Endoscopic Evaluation of Swallowing (DIGEST-FEES). The DIGEST-FEES is a validated, ordinal rating scale that integrates measures of airway invasion (penetration-aspiration) and pharyngeal residue to generate a composite severity grade of dysphagia. Scores range from 0 (no dysphagia) to 4 (life-threatening dysphagia), with higher scores indicating greater swallowing impairment.
Time frame
BaselineSecondary outcomes
1
Neural Activation Patterns (fMRI)
Functional brain activity during swallowing tasks will be assessed using fMRI. Focus is on compensatory activation patterns in cortical and subcortical areas associated with swallowing control.
Time frame
Baseline2
Electromyography (EMG) of Swallowing Muscles
Surface EMG recordings will assess the number of swallows during fMRI
Time frame
Baseline3
Change in Global Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a validated, brief screening tool designed to detect mild cognitive impairment and broader cognitive dysfunction. The MoCA evaluates multiple cognitive domains, including: Attention and concentration Executive functioning Memory Language Visuospatial skills Abstraction Orientation Total scores range from 0 to 30, with higher scores indicating better cognitive performance. A change in MoCA score over time will be used to assess change in overall cognitive function.
Time frame
Baseline4
Change in Swallowing-Related Quality of Life as Assessed by the Swallowing Quality of Life Questionnaire (SWAL-QOL)
Swallowing-related quality of life will be assessed using the Swallowing Quality of Life Questionnaire (SWAL-QOL), a validated, patient-reported outcome measure designed specifically to evaluate the impact of dysphagia on daily functioning and well-being. The SWAL-QOL consists of 44 items across multiple domains, including: Burden Eating duration Eating desire Food selection Communication Fear Mental health Social functioning Fatigue Sleep Item responses are converted to domain and total scores typically scaled from 0 to 100, with higher scores indicating better swallowing-related quality of life. Change in SWAL-QOL total score (and/or domain scores) over time will be used to assess patient-perceived treatment effect.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Heinrich-Heine University, Duesseldorf
Lead sponsor
German Research Foundation
Collaborator
Source ClinicalTrials.gov