Ultrasound Shear Wave Elastography in Parkinson's Disease

January 31, 2025 updated by: Romany Kamal Farah, Assiut University

Ultrasound Shear Wave Elastography for Assessing Muscle Stiffness in Parkinson's Disease Patients

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by motor symptoms including muscle rigidity as one of major motor symptoms affecting quality of life of Parkinson's disease patients, thus we aim to assess and quantify muscle stiffness in those patients using Ultrasound shear wave elastography .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by motor symptoms like tremors, bradykinesia, muscle rigidity, and postural instability, as well as various non-motor symptoms . While the exact cause of Parkinson's disease is not fully understood, it is thought to result from a combination of genetic and environmental factors, leading to the degeneration of dopamine-producing neurons in the brain . PD is the second most common neurodegenerative disorder after Alzheimer's disease, primarily affecting those over 60, with a higher prevalence in men . The disease significantly impacts quality of life due to progressive motor and non-motor disabilities, and while treatments can alleviate symptoms, there is currently no cure . Disease progression and prognosis vary, with advanced stages often leading to severe disability and reduced life expectancy .

Muscle rigidity, one of the major motor symptoms, refers to the increased resistance when muscles are passively stretched . Accurate assessment of muscle stiffness is essential for monitoring disease progression and evaluating therapeutic interventions .

Traditionally, clinical assessment tools like the Unified Parkinson's Disease Rating Scale (UPDRS), part III, are used to evaluate rigidity severity in PD patients . These assessments, involving manual joint movement and muscle palpation by professionals, are subjective and prone to error . Thus, there is a growing need for noninvasive, quantitative tools to assess muscle stiffness in PD patients .

Tools like electromyography (EMG) and myotonometry offer quantitative measurements . Ultrasound shear wave elastography (SWE) is another non-invasive technique that measures tissue stiffness by analyzing shear wave propagation. While SWE shows promise for various conditions, its application in PD-related muscle rigidity remains relatively unexplored .

Study Type

Observational

Enrollment (Estimated)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Any patients diagnosed with Parkinson's disease and meeting the eligibility criteria.

Description

Inclusion Criteria:

  • patient diagnosed with Parkinson's disease
  • Age between 40-85 years
  • No other neurological or musculoskeletal disorders affecting the examined limb muscles.

Exclusion Criteria:

  • History of other neurological or musculoskeletal disorders affecting the examined limb muscles.
  • History of significant trauma or surgery in the examined limb within the last year.
  • patients with contraindications to ultrasound( such as open skin wounds or severe skin conditions in the area of interest).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson's patients group
Parkinson's disease diagnosed patients who meet the eligibility criteria and not complain of other neurological or musculoskeletal diseases that can affect muscle stiffness.
Device: Ultrasound shear wave elastography
An ultrasound machine (GE LogiQ S8) equipped with SWE technology will be used. A high-frequency linear transducer will be used and The machine settings will be optimized for musculoskeletal applications.
Healthy non Parkinson's group
Healthy age matched individuals who do not meet the criteria of Parkinson's disease diagnosis and not complain of other neurological or musculoskeletal diseases that can affect muscle stiffness.
Device: Ultrasound shear wave elastography
An ultrasound machine (GE LogiQ S8) equipped with SWE technology will be used. A high-frequency linear transducer will be used and The machine settings will be optimized for musculoskeletal applications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of muscle stiffness in the study groups.
Time Frame: Baseline
The primary outcome will be the measurement of muscle stiffness using Ultrasound Shear Wave Elastography (SWE) and comparing muscle stiffness values between Parkinson's disease patients and healthy non Parkinson's controls.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of the measured muscle stiffness with clinical severity of Parkinson's disease.
Time Frame: Baseline
Secondary outcomes will include the correlation of muscle stiffness values with clinical severity scores, such as the Unified Parkinson's Disease Rating Scale (UPDRS). This will help to assess the relationship between increased muscle stiffness and the progression of Parkinson's Disease.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Afaf A. Hassan, PROFESSOR
  • Study Director: Radwa K. Abdel-Naser, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ultrasound SWE in Parkinson's

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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