Link gait freezing with swallowing

Trial ID
NCT06713265
Official Title
Study of the Link Between Freezing of Gait and Oropharyngeal Freezing in Parkinson's Patients
Goal
Link gait freezing with swallowing
Status
RECRUITING
Sponsor
Hopital La Musse
Study Type
OBSERVATIONAL
Enrollment
66 participants
Conditions
Parkinson's Disease, Dysphagia, Swallowing Disorder, Freezing of Gait, Oropharyngeal Disease, Gait Disorders

Summary For Families

The goal is to find out whether the brief "freezing" episodes people with Parkinson's get when walking are linked to similar freezes in the throat that cause swallowing difficulty. To do that, researchers will observe and measure walking-related freezing and oropharyngeal swallowing function using clinical and instrumental assessments, looking at timing and severity to see if the episodes are related; no drug or device is being tested. They are enrolling adults 18 and older with neurologist-diagnosed idiopathic Parkinson's who are affiliated with the social security system, excluding people with other neurological or ENT causes of swallowing problems, those with a gastrostomy and no oral intake, people under legal protection, and pregnant women.

Locations

  • Hôpital La Musse, Saint-Sébastien-de-Morsent, France

Frequently Asked Questions

What is this trial testing?
This trial is studying an experimental treatment. The goal is to find out whether the brief "freezing" episodes people with Parkinson's get when walking are linked to similar freezes in the throat that cause swallowing difficulty. To do that, researchers will observe and measure walking-related freezing and oropharyngeal swallowing function using clinical and instrumental assessments, looking at timing and severity to see if the episodes are related; no drug or device is being tested. They are enrolling adults 18 and older with neurologist-diagnosed idiopathic Parkinson's who are affiliated with the social security system, excluding people with other neurological or ENT causes of swallowing problems, those with a gastrostomy and no oral intake, people under legal protection, and pregnant women.
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 1 year and 1 month.
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.

Related Reading

View on ClinicalTrials.gov