Biological Determinants and Neural Compensation of Dysphagia in Parkinson's Disease

NCT07299448 | Recruiting

• 2 other identifiers: 2023-2374529859742
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinsons Disease (PD); Oropharyngeal Dysphagia

Keywords

Dysphagia, Swallowing Disorder, Parkinson's Disease, Swallowing Compensation, Neuroimaging Biomarkers, Functional MRI, Proteomics

Outcome Measures

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.

  Baseline

Secondary Outcomes (6)

• Neural Activation Patterns (fMRI)

  Baseline

• Electromyography (EMG) of Swallowing Muscles

  Baseline

• Change in Global Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)

  Baseline

• Change in Swallowing-Related Quality of Life as Assessed by the Swallowing Quality of Life Questionnaire (SWAL-QOL)

  Baseline

• Change in Airway Invasion Severity as Assessed by the Penetration-Aspiration Scale (PAS)

  Baseline

Study Arms (1)

Parkinson's Disease Patients with Dysphagia

Participants who have been diagnosed with Parkinson's disease and are still able to eat and drink independently. These individuals undergo a detailed examination of their swallowing function, compensatory mechanisms, and the neural correlates of dysphagia.

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

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.

You may qualify if:

• Patients with idiopathic Parkinson's disease diagnosed according to the MDS diagnostic criteria
• 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

You may not qualify if:

• 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")

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• German Research Foundation: collaborator

Study Sites (1)

University Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and cerebrospinal fluid (CSF) samples will be retained for proteomic analyses. No DNA or genetic testing will be performed. Samples will be stored under standardized biobanking conditions for future protein-based investigations related to dysphagia and Parkinson's disease

MeSH Terms

Conditions

Parkinson Disease; Deglutition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Bendix Labeit

CONTACT

0049211811887; Bendix.Labeit@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 23, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: beginning of recruitment until end of study

Locations

DE (1)