Menu
Not yet recruiting NCT06701318

Ultrasound Shear Wave Elastography in Parkinson's Disease

Observational Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound shear wave elastography.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 .

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 .

Interventions

  • 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.

Primary outcome measures

  • Quantification of muscle stiffness in the study groups. [Time frame: Baseline]
Secondary outcome measures (1)
  • Correlation of the measured muscle stiffness with clinical severity of Parkinson's disease. [Time frame: Baseline]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Khan AU, Akram M, Daniyal M, Zainab R. Awareness and current knowledge of Parkinson's disease: a neurodegenerative disorder. Int J Neurosci. 2019 Jan;129(1):55-93. doi: 10.1080/00207454.2018.1486837. Epub 2018 Nov 22. PMID 29883227
  • Prajjwal P, Flores Sanga HS, Acharya K, Tango T, John J, Rodriguez RSC, Dheyaa Marsool Marsool M, Sulaimanov M, Ahmed A, Hussin OA. Parkinson's disease updates: Addressing the pathophysiology, risk factors, genetics, diagnosis, along with the medical and surgical treatment. Ann Med Surg (Lond). 2023 Aug 8;85(10):4887-4902. doi: 10.1097/MS9.0000000000001142. eCollection 2023 Oct. PMID 37811009
  • Cui L, Hou NN, Wu HM, Zuo X, Lian YZ, Zhang CN, Wang ZF, Zhang X, Zhu JH. Prevalence of Alzheimer's Disease and Parkinson's Disease in China: An Updated Systematical Analysis. Front Aging Neurosci. 2020 Dec 21;12:603854. doi: 10.3389/fnagi.2020.603854. eCollection 2020. PMID 33424580
  • Church FC. Treatment Options for Motor and Non-Motor Symptoms of Parkinson's Disease. Biomolecules. 2021 Apr 20;11(4):612. doi: 10.3390/biom11040612. PMID 33924103
  • Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10. PMID 33848468
  • Yin L, Du L, Li Y, Xiao Y, Zhang S, Ma H, He W. Quantitative Evaluation of Gastrocnemius Medialis Stiffness During Passive Stretching Using Shear Wave Elastography in Patients with Parkinson's Disease: A Prospective Preliminary Study. Korean J Radiol. 2021 Nov;22(11):1841-1849. doi: 10.3348/kjr.2020.1338. Epub 2021 Aug 19. PMID 34431245
  • Rovini E, Maremmani C, Cavallo F. How Wearable Sensors Can Support Parkinson's Disease Diagnosis and Treatment: A Systematic Review. Front Neurosci. 2017 Oct 6;11:555. doi: 10.3389/fnins.2017.00555. eCollection 2017. PMID 29056899
  • Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkin PMID 19025984

Identifiers

NCT: NCT06701318 · Ultrasound SWE in Parkinson's

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗