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NCT Number: NCT06655727

Evaluation of Dysphagia in Patients Diagnosed With Parkinson's Disease by Ultrasound

The primary aim of this study is to perform an ultrasonographic swallowing assessment in Parkinson's patients and healthy volunteers and compare the findings with those from clinical swallowing evaluations. The secondary aim is to examine the relationship between dysphagia and functional status.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

About this study

Thirty patients aged 40-80 years, diagnosed with idiopathic Parkinson's disease (Modified Hoehn-Yahr stage 1-3), and thirty healthy volunteers who either applied to the Physical Therapy and Rehabilitation outpatient clinic or received inpatient rehabilitation at Beylikdüzü State Hospital and Istanbul Physical Medicine and Rehabilitation Training and Research Hospital will be included in this study. At the start of the study, sociodemographic data of both patients and volunteers will be recorded. The Mini-Mental Test and the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used to evaluate the mental and functional status of the patients diagnosed with Parkinson's disease. After the clinical dysphagia evaluation, the EAT-10 questionnaire will be administered to the participants. Following this, an ultrasonographic swallowing assessment will be performed on the participants. The ultrasonographic measurements will include tongue thickness (cm), resting distance between the mandible and hyoid (cm), shortest distance between the mandible and hyoid (cm), hyoid displacement (cm), hyoid displacement percentage, tongue thickness (cm) (with 5ml of water), resting distance between the mandible and hyoid (cm) (with 5ml of water), shortest distance between the mandible and hyoid (cm) (with 5ml of water), hyoid displacement (cm) (with 5ml of water), and hyoid displacement percentage (%) (with 5ml of water).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of idiopathic Parkinson's disease by a neurologist.
  • Being in stages 1-3 according to the Modified Hoehn-Yahr Staging Scale.
  • Scoring at least 24 on the Mini-Mental State Examination (MMSE).
  • Not having received any therapy or treatment affecting swallowing, other than routine medication for Parkinson's disease.

Exclusion criteria

  • Presence of head or neck cancer that could cause dysphagia.
  • History of radiotherapy or surgery in the head and neck region.
  • Diagnosis of vascular parkinsonism or stroke.
  • Presence of cardiopulmonary disease that could affect swallowing or breathing.
  • Having received voice or swallowing therapy in the last 6 months.
  • Presence of a diagnosed psychiatric disorder.

Treatment and study plan

Ultrasound evaluation

Diagnostic Test

No intervention

Primary outcomes

  1. The EAT-10 (Eating Assessment Tool-10)

    Time frame: 0 day

    The EAT-10 (Eating Assessment Tool-10) is a validated self-administered questionnaire designed to assess symptoms of dysphagia (difficulty swallowing). It consists of 10 questions that evaluate the severity of swallowing difficulties, including issues related to eating, drinking, and managing saliva. Each item is rated on a 5-point scale, ranging from 0 (no problem) to 4 (severe problem). A total score of 3 or higher suggests the presence of clinically significant dysphagia, and it helps guide further diagnostic evaluation and management.

  2. Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: 0 day

    The UPDRS is a comprehensive tool used to evaluate the severity and progression of Parkinson's disease. It consists of multiple sections assessing motor and non-motor symptoms, helping clinicians understand the impact of the disease on daily functioning. The UPDRS is widely used in both clinical practice and research to monitor disease progression and treatment effects.

    In the MDS-UPDRS, higher scores indicate more severe Parkinson's disease symptoms. Each item is rated from 0 (normal) to 4 (severe), with the total score reflecting the overall disease severity. A higher total score means worse motor and non-motor symptoms, indicating greater impairment and reduced quality of life. Lower scores suggest milder symptoms and better functional status.

Secondary outcomes

  1. Tongue Thickness

    Time frame: 0 day

    Tongue thickness refers to the measurement of the width or thickness of the tongue in centimeters. This parameter is evaluated using ultrasound to assess the muscle mass and structural integrity of the tongue, which plays a critical role in swallowing function. In conditions like dysphagia, reduced tongue thickness may indicate weakened tongue muscles, contributing to swallowing difficulties.

  2. Distance Between the Hyoid and Mandible

    Time frame: 0 day

    This is the measurement of the space between the hyoid bone and the mandible (lower jaw) while the individual is at rest or during swallowing. It is typically measured in centimeters and can provide insights into the positioning and movement of structures involved in swallowing. An abnormal distance between these structures may indicate dysfunction in the swallowing mechanism.

  3. Hyoid Displacement Distance:

    Time frame: 0 day

    The hyoid bone plays a key role in the swallowing process by facilitating the elevation and forward movement of the larynx. Insufficient hyoid displacement can lead to impaired swallowing function, as it affects the coordination of muscles involved in the swallow. The measurement of this displacement helps assess the efficiency and safety of the swallowing mechanism.

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Evaluation of Dysphagia in Patients Diagnosed With Parkinson's Disease by Ultrasound: A Controlled Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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