The Effect of an Auditory Rhythmic Cue on the Frequency of Rolling in Patients with Dysphagia and… (NCT06695455) | Clinical Trial Compass
RecruitingNot Applicable
The Effect of an Auditory Rhythmic Cue on the Frequency of Rolling in Patients with Dysphagia and Parkinson's Disease
France18 participantsStarted 2024-04-05
Plain-language summary
The main objective of this clinical study is to measure the effect of rhythmic auditory cueing, introduced in rehabilitation with three weekly sessions over a period of 7 weeks, on the frequency of rolling in idiopathic Parkinson's disease patients using pharyngography (swallowing radiography). The primary question of this study is:
Does the rhythmic cueing introduced in rehabilitation significantly reduce the frequency of rolling in dysphagic Parkinson's patients?
The researchers will assess the various stages of swallowing before, after, and 3 months after the rehabilitation protocol, focusing on the oral phase to determine if rhythmic auditory cueing reduces the frequency of rolling.
Participants will be required to:
* Perform three complete assessments (clinical speech therapy examination + pharyngography) before the protocol, after the protocol, and 3 months post-protocol.
* Attend three times per week for 7 weeks at the La Musse hospital to participate in the protocol sessions under the supervision of a speech therapist.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of idiopathic Parkinson's disease established by a neurologist using a DAT SCAN and clinical examination;
* Presence of a swallowing disorder, specifically rolling;
* Patient affiliated with the social security system;
* Patient aged 18 years or older
Exclusion Criteria:
* Severe pharyngeal dysphagia (leading to aspiration with nectar and pudding textures);
* Severe cognitive impairment (score \<24 on the Mini Mental Parkinson test);
* Known deafness/profound hearing loss;
* Patients under legal protection measures;
* History of reconstructive ENT surgery at the oropharyngeal level;
* Neurological history that could cause a swallowing disorder (e.g., stroke);
* Patient with a gastrostomy and no oral feeding;
* Ongoing speech therapy for swallowing;
* The patient is included in another research protocol;
* Pregnant women or women suspected of being pregnant;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The measurement of the frequency of rolling per minute during a pharyngography
Timeframe: Pre-test (before the rehabilitation protocol), Post-test (after the rehabilitation protocol), and Follow-up test (3 months after the completion of the protocol).