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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia; Swallowing Disorder; PARKINSON DISEASE (Disorder); Oral Festination; Lingual Pumping
• Intervention / Treatment: Behavioral: Swallowing rehabilitation by rhythmic auditory cue

Detailed Description

Dysphagia can negatively affect the quality of life of patients. Indeed, it leads to difficulties during oral intake (food, drinks, and medications), weight loss, dehydration, malnutrition, and limitations in social activities. Depression is frequently associated with a reduced quality of life in Parkinson's patients with swallowing disorders. Additionally, aspiration pneumonia due to aspiration events is one of the main causes of hospitalization in Parkinson's patients, and it can lead to severe complications and sometimes death.

This clinical study focuses on "rolling," also known as oropharyngeal festination, which is an involuntary, repetitive, anteroposterior movement of the tongue at the level of the soft palate, performed before the food bolus is swallowed.

Rolling is an intrinsically rhythmic movement. The few studies conducted on the subject agree, however, that freezing of gait (difficulties in initiating movement, stopping in front of an obstacle, or navigating around it) and rolling share common pathophysiological mechanisms. Freezing of gait is not limited to a deficit within the locomotor network but rather reflects a more general deficit affecting spatiotemporal coordination across various tasks, just like rolling.

The use of rhythmic auditory cueing (applying rhythmic auditory training to intrinsically rhythmic movements, such as walking, with the aim of achieving more functional movement patterns) has been evaluated in different studies and has proven effective in reducing the frequency of freezing of gait in Parkinson's patients. It thus seems relevant to apply this rehabilitation method to rolling in these same patients to study the effect of auditory cueing on rolling. The secondary objectives will mainly focus on evaluating the effect of auditory cueing on the swallowing abilities of Parkinson's patients, their physical health, and their quality of life.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Héloïse BAILLET, PhD; Phone Number: +33 (0)2 32 29 30 47; Email: h.baillet@hlrs-lamusse.net

Study Locations

• France
  • Normandie
    • Saint Sébastien de Morsent, Normandie, France, 27180
      • Recruiting
      • Hôpital La Musse - La Renaissance Sanitaire
      • Contact: Julie LE BALC'H; Phone Number: =33 (0)2 32 29 30 01; Email: j.lebalch@hlrs-lamusse.net
      • Contact: Héloïse BAILLET, PhD
      • Contact: Eric VERIN, MD, PhD
      • Contact: Audrey BRINGER, MD - MSc
      • Contact: Eléna DEFROMERIE, MSc - CCC- SLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: experimental arm - dysphagic parkinson patient; dysphagic parkinson patient

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Hopital La Musse
• Collaborators: France Parkinson Association

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Estimated): January 5, 2026
• Study Completion (Estimated): September 5, 2026

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: behavioral intervention; rehabilitation; dysphagia; swallowing disorder; parkinson disease; oral festination; lingual pumping; rhythmic auditory cue
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Neurodegenerative Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Movement Disorders; Pharyngeal Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Disease; Parkinson Disease; Deglutition Disorders
• Other Study ID Numbers: 2023-A02487-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No