Biological causes and brain compensation of swallowing problems in Parkinson's disease
Official title: Biological Determinants and Neural Compensatory Mechanisms of Oropharyngeal Dysphagia in Parkinson's Disease
Run by Heinrich-Heine University, Duesseldorf · NCT07299448 · Data updated 2026-11-12
This study will test whether specific biological markers and brain activity patterns explain and help compensate for swallowing problems in people with Parkinson's disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 2027 |
| Study ends | January 2028 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07299448 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with idiopathic Parkinson's disease (any stage) who can follow study procedures, take food and fluids by mouth, and have no contraindications to MRI.
✕Probably not a fit
Patients with exclusive tube feeding, other causes of oropharyngeal dysphagia (e.g., stroke, head and neck cancer), implanted electronic devices that preclude MRI, or asthma/COPD are excluded and would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study enrolls people with idiopathic Parkinson's disease across all disease stages to combine clinical swallowing exams, cough-reflex and pharyngeal sensitivity testing, functional MRI of the swallowing network, and proteomic analyses. Participants will undergo standardized clinical and instrumental swallow assessments alongside neuroimaging to identify neural compensation and correlate those findings with blood-derived biological markers. The goal is to link clinical severity and swallowing outcomes to specific neural and molecular signatures that may explain why some patients preserve safe swallowing. Results will inform biomarkers and targets for future intervention trials.
Why it matters
Potential benefit: If successful, the work could identify biomarkers and neural signatures that improve prediction of aspiration risk and guide targeted therapies to reduce pneumonia, malnutrition, and medication problems.
How similar studies have gone: Prior imaging and biomarker studies have suggested neural compensation and molecular changes in swallowing, but combining multimodal neuroimaging with proteomics in PD is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: .- 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 * Daily oral intake of food and fluids (exclusion of patients with exclusive tube feeding) Exclusion Criteria: * 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")
Where it's running
-
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Study coordinator: Bendix Labeit
- Email: Bendix.Labeit@med.uni-duesseldorf.de
- Phone: 0049211811887
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.