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Clinical Trials in France / NCT06695455
Recruiting Not applicable

The Effect of an Auditory Rhythmic Cue on the Frequency of Rolling in Patients with Dysphagia and Parkinson's Disease

NCT06695455 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-04-05
Last updated
2024-11-19

Condition(s) studied

Oral FestinationLingual PumpingDysphagiaSwallowing DisorderPARKINSON DISEASE (Disorder)

Investigational drug(s) / intervention(s)

Swallowing rehabilitation by rhythmic auditory cue

Swallowing rehabilitation by rhythmic auditory cue: Three assessments, each spread over two days, will be administered at three different time points during the study: before the experiment (T0), after 7 weeks of the experiment (T1), and 3 months after the intervention (T2). The evaluation will include a pharyngography as well as a clinical assessment of swallowing and rhythmic abilities. Each subject will be invited to participate in 3 individual rehabilitation sessions per week for 7 weeks, conducted by a speech therapist at La Musse Hospital. Each session will be structured similarly: the subject will be asked to swallow their saliva, followed by a nectar-like texture (IDDSI 2) and a pudding-like texture (IDDSI 4), timed to the rhythm of a metronome. The rhythm will vary throughout the sessions. The goal will be to get as close as possible to the rhythm of a healthy swallow.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hôpital La Musse - La Renaissance Sanitaire Saint-Sébastien-de-Morsent Normandy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06695455 on ClinicalTrials.gov ↗ ← All trials in France