Study of the Link Between Freezing of Gait and Oropharyngeal Freezing in Parkinson's Patients

NCT06713265 | Recruiting

• 1 other identifier: 2024-A01781-46
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's Disease: Study of the Link Between Gait Freezing and Oropharyngeal Freezing Parkinson's disease is the second most common neurodegenerative disorder worldwide. Parkinsonian dysphagia is a frequently encountered disorder in this condition, affecting all phases of swallowing: oral, pharyngeal, and esophageal. This dysphagia can occur at any stage of the disease. While most swallowing difficulties develop in the advanced stages of Parkinson's disease, they can also appear early on and are often underdiagnosed. The prevalence of swallowing disorders in Parkinson's disease is estimated to range from 40% to 80%, with this variability explained by the significant differences in the precision of swallowing evaluations conducted and the fact that dysphagia is still too frequently underdiagnosed. Yet, dysphagia is the leading cause of mortality in Parkinson's patients. Dysphagia can negatively affect patients' quality of life. It leads to difficulties during oral intake (food, liquids, and medications), weight loss, dehydration, malnutrition, and limitations in social activities. Depression is frequently associated with reduced quality of life in Parkinson's patients with swallowing disorders. Moreover, aspiration pneumonia due to mis-swallowing is one of the primary reasons for hospitalization in Parkinson's patients, potentially leading to severe complications and, at times, death. Oropharyngeal freezing, also called oral festination, is an involuntary, repetitive anteroposterior movement of the tongue against the soft palate performed before transferring the food bolus to the pharynx. This movement is also observed during multiple swallows. This phenomenon is more frequent in dysphagic Parkinson's patients, yet its impact on swallowing dynamics remains poorly understood. Oropharyngeal freezing has been observed in approximately 40% to 75% of Parkinson's patients during videofluoroscopic swallow studies, also known as swallowing pharyngography. Oropharyngeal freezing inhibits the initiation of swallowing, keeping the airway open and leading to tracheal aspiration of residues. Some fragments then slide into the valleculae and pyriform sinuses. Thus, oropharyngeal freezing exacerbates pharyngeal phase incoordination, increasing the risk of aspiration pneumonia. Therefore, addressing this swallowing disorder is essential. Oropharyngeal freezing is intrinsically rhythmic. While limited studies have been conducted on the topic, they agree that gait freezing (difficulty initiating walking, stopping in response to obstacles, or circumventing them) and oropharyngeal freezing share common pathophysiological mechanisms. Gait freezing is not limited to deficits in the locomotor network but is part of a broader deficit affecting spatiotemporal coordination in various tasks, similar to oropharyngeal freezing. It is, therefore, crucial to detect this oral phase swallowing disorder as early as possible, enabling tailored early intervention that helps patients maintain their swallowing abilities for as long as possible and prevents complications mentioned earlier. Since gait freezing is diagnosed much earlier and more systematically, it would be interesting to investigate whether there is a correlation between the presence of gait freezing and oropharyngeal freezing in these patients. This could guide patients with gait freezing toward early speech-language assessments to evaluate the presence of oropharyngeal freezing. The objectives of the study are examine the prevalence of oropharyngeal freezing in Parkinson's patients. Based on the results obtained from the NFOG-Q (New Freezing of Gait Questionnaire), two groups will be formed: The first group will consist of patients exhibiting gait freezing. The second group will consist of patients without gait freezing. The secondary objectives of the study are examine the common characteristics between these two types of freezing (gait and oropharyngeal). To assess the sensitivity and reliability of the NFOG-Q in detecting oropharyngeal freezing.To determine the prevalence of oropharyngeal freezing based on the score obtained on the UPDRS (Unified Parkinson's Disease Rating Scale). To analyze the link between patients' rhythmic abilities and the presence or absence of one or both types of freezing.

Conditions

Parkinson's Disease; Dysphagia; Swallowing Disorder; Freezing of Gait; Oropharyngeal Disease; Gait Disorders

Keywords

Parkinson's Disease; Dysphagia; Swallowing disorder; Freezing of gait; oropharyngeal freezing; Gait

Outcome Measures

Primary Outcomes (1)

• The judgment of the presence or absence of oropharyngeal freezing during a pharyngography in the OFF phase of an idiopathic Parkinson's disease patient.

  Pharyngography is a swallowing examination that allows for recording films of the patient's swallowing using a radiological device. The radiology device will be positioned at the patient's neck and will record these sequences. Once the device is in place, the patient will swallow bites of varying thickness. For all swallowing actions, barium will be used, which is a radiopaque, white substance with a slightly mentholated taste.

  At the enrollement

Secondary Outcomes (11)

• The objective assessment of the severity, fluctuation, and progression of clinical symptoms, as well as their impact on the patient's daily life.

  At the enrollement

• Assessment of gait freezing

  At the enrollement

• Assessment of gait freezing 2

  At the enrollement

• Rhythm assessment

  At the enrollement

• Assessment of swallowing disorders

  At the enrollement

Study Arms (2)

With freezing of gait

During patient enrollment, the following assessments will be conducted: * The Unified Parkinson's Disease Rating Scale (UPDRS); * Timed Up \& Go (TUG) Test; * New Freezing of Gait Questionnaire (NFOG-Q); * BAASTA Battery; * Clinical swallowing assessment. All assessments will be conducted during the patient's OFF phase. At the end of the motor assessment (NFOG-Q and TUG), the patients will be divided into two groups: the first group will consist of patients exhibiting freezing of gait, while the second group will consist of those not presenting freezing. The procedure for the assessments will remain the same for both groups. If, during the clinical speech therapy swallowing assessment, signs indicative of swallowing disorders are detected, the patient will be referred for a pharyngography to specify the nature of these disorders.

Without freezing of gait

During patient enrollment, the following assessments will be conducted: * The Unified Parkinson's Disease Rating Scale (UPDRS); * Timed Up \& Go (TUG) Test; * New Freezing of Gait Questionnaire (NFOG-Q); * BAASTA Battery; * Clinical swallowing assessment. All assessments will be conducted during the patient's OFF phase. At the end of the motor assessment (NFOG-Q and TUG), the patients will be divided into two groups: the first group will consist of patients exhibiting freezing of gait, while the second group will consist of those not presenting freezing. The procedure for the assessments will remain the same for both groups. If, during the clinical speech therapy swallowing assessment, signs indicative of swallowing disorders are detected, the patient will be referred for a pharyngography to specify the nature of these disorders.

Eligibility Criteria

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

Study Population

The chosen study population consists of patients with idiopathic Parkinson's disease.

You may qualify if:

• Diagnosis of idiopathic Parkinson's disease established by a neurologist;
• Patient affiliated with the social security system;
• Patient aged over 18 years.

You may not qualify if:

• Patients under legal protection measures;
• Neurological history that could be the cause of a swallowing disorder (e.g., stroke) or a history of ENT cancer;
• Patient with a gastrostomy without oral intake;
• Pregnant women or those suspected of being pregnant;
• Minor patients

Sponsors & Collaborators

• Hopital La Musse: lead

Study Sites (1)

Hôpital La Musse

Saint-Sébastien-de-Morsent, 27180, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Deglutition Disorders; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Héloïse BAILLET, PhD

  Hôpital La Musse

  PRINCIPAL INVESTIGATOR

• Eric VERIN, PU-PH

  CHU Rouen, GRHVN Laboratory

  STUDY DIRECTOR

Central Study Contacts

Héloïse BAILLET, PhD

CONTACT

+33(0)232293047; h.baillet@hlrs-lamusse.net

Julie LE BALC'H

CONTACT

+33(0)232293001; j.lebalch@hlrs-lamusse.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: October 4, 2024
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-09

Locations

FR (1)