Ultrasound Shear Wave Elastography in Parkinson's Disease
1 other identifier
observational
68
0 countries
N/A
Brief Summary
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2024
CompletedFirst Posted
Study publicly available on registry
November 22, 2024
CompletedStudy Start
First participant enrolled
February 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedFebruary 3, 2025
January 1, 2025
28 days
November 20, 2024
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantification of muscle stiffness in the study groups.
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 Outcomes (1)
Correlation of the measured muscle stiffness with clinical severity of Parkinson's disease.
Baseline
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
Any patients diagnosed with Parkinson's disease and meeting the eligibility criteria.
You may qualify if:
- patient diagnosed with Parkinson's disease
- Age between 40-85 years
- No other neurological or musculoskeletal disorders affecting the examined limb muscles.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (12)
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: 29883227BACKGROUNDPrajjwal 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: 37811009BACKGROUNDCui 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: 33424580BACKGROUNDChurch 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: 33924103BACKGROUNDBloem 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: 33848468BACKGROUNDYin 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: 34431245BACKGROUNDRovini 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: 29056899BACKGROUNDGoetz 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 Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
PMID: 19025984BACKGROUNDKim MR, Yun JY, Jeon B, Lim YH, Kim KR, Yang HJ, Paek SH. Patients' reluctance to undergo deep brain stimulation for Parkinson's disease. Parkinsonism Relat Disord. 2016 Feb;23:91-4. doi: 10.1016/j.parkreldis.2015.11.010. Epub 2015 Nov 19.
PMID: 26686260BACKGROUNDGuerra A, D'Onofrio V, Ferreri F, Bologna M, Antonini A. Objective measurement versus clinician-based assessment for Parkinson's disease. Expert Rev Neurother. 2023 Jul-Dec;23(8):689-702. doi: 10.1080/14737175.2023.2229954. Epub 2023 Jul 6.
PMID: 37366316BACKGROUNDDrakonaki EE, Allen GM, Wilson DJ. Real-time ultrasound elastography of the normal Achilles tendon: reproducibility and pattern description. Clin Radiol. 2009 Dec;64(12):1196-202. doi: 10.1016/j.crad.2009.08.006. Epub 2009 Oct 8.
PMID: 19913130BACKGROUNDKronlage C, Grimm A, Romano A, Stahl JH, Martin P, Winter N, Marquetand J. Muscle Ultrasound Shear Wave Elastography as a Non-Invasive Biomarker in Myotonia. Diagnostics (Basel). 2021 Jan 23;11(2):163. doi: 10.3390/diagnostics11020163.
PMID: 33498617BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Afaf A. Hassan
Professor
- STUDY DIRECTOR
Radwa K. Abdel-Naser
Assistant professor
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 20, 2024
First Posted
November 22, 2024
Study Start
February 1, 2025
Primary Completion
March 1, 2025
Study Completion
March 1, 2026
Last Updated
February 3, 2025
Record last verified: 2025-01