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

NCT06695455 | Recruiting

• 1 other identifier: 2023-A02487-38
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Festination; Lingual Pumping; Dysphagia; Swallowing Disorder; PARKINSON DISEASE (Disorder)

Keywords

oral festination; lingual pumping; dysphagia; swallowing disorder; parkinson disease; rhythmic auditory cue; rehabilitation; behavioral intervention

Outcome Measures

Primary Outcomes (1)

• The measurement of the frequency of rolling per minute during a pharyngography

  Multiple measurements will be taken to calculate the average.

  Pre-test (before the rehabilitation protocol), Post-test (after the rehabilitation protocol), and Follow-up test (3 months after the completion of the protocol).

Study Arms (1)

experimental arm - dysphagic parkinson patient

EXPERIMENTAL

dysphagic parkinson patient

Behavioral: Swallowing rehabilitation by rhythmic auditory cue

Interventions

Swallowing rehabilitation by rhythmic auditory cue BEHAVIORAL

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.

experimental arm - dysphagic parkinson patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hopital La Musse: lead
• France Parkinson Association: collaborator

Study Sites (1)

Hôpital La Musse - La Renaissance Sanitaire

Saint-Sébastien-de-Morsent, Normandy, 27180, France

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Parkinson Disease

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Héloïse BAILLET, PhD

CONTACT

+33 (0)2 32 29 30 47; h.baillet@hlrs-lamusse.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional research with minimal risks and constraints Prospective, Interventional, Monocentric, without a control group

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 19, 2024
• Study Start: April 5, 2024
• Primary Completion: January 5, 2026
• Study Completion (Estimated): September 5, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

FR (1)