Biological causes and brain compensation of swallowing problems in Parkinson's disease
Biological Determinants and Neural Compensatory Mechanisms of Oropharyngeal Dysphagia in Parkinson's Disease
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Trial ID | NCT07299448 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Düsseldorf, North Rhine-Westphalia
- University Hospital Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Study coordinator: Bendix Labeit
- Email: Bendix.Labeit@med.uni-duesseldorf.de
- Phone: 0049211811887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.