Identify neural causes of dysphagia
- Trial ID
- NCT07299448
- Official Title
- Biological Determinants and Neural Compensatory Mechanisms of Oropharyngeal Dysphagia in Parkinson's Disease
- Goal
- Identify neural causes of dysphagia
- Status
- RECRUITING
- Sponsor
- Heinrich-Heine University, Duesseldorf
- Study Type
- OBSERVATIONAL
- Enrollment
- 100 participants
- Conditions
- Parkinsons Disease (PD), Oropharyngeal Dysphagia
Summary For Families
They want to pin down the biological factors and brain compensation patterns that lead to or protect against oropharyngeal dysphagia, the swallowing problems many people with Parkinson's can develop. As an observational study, researchers will use brain MRI, cough reflex and throat-sensation tests, and clinical swallowing assessments to map how sensory loss and altered neural networks relate to swallowing function, they are measuring how the body and brain behave rather than testing a treatment. Adults 18 and older with idiopathic Parkinson's at any disease stage who can eat orally and follow the testing can join, while people with other causes of dysphagia, implanted electronic stimulators or MRI contraindications, or asthma/COPD are excluded.
Locations
- University Hospital Düsseldorf, Düsseldorf, North Rhine-Westphalia, Germany
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. They want to pin down the biological factors and brain compensation patterns that lead to or protect against oropharyngeal dysphagia, the swallowing problems many people with Parkinson's can develop. As an observational study, researchers will use brain MRI, cough reflex and throat-sensation tests, and clinical swallowing assessments to map how sensory loss and altered neural networks relate to swallowing function, they are measuring how the body and brain behave rather than testing a treatment. Adults 18 and older with idiopathic Parkinson's at any disease stage who can eat orally and follow the testing can join, while people with other causes of dysphagia, implanted electronic stimulators or MRI contraindications, or asthma/COPD are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.