NCT06701318

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

28 days

First QC Date

November 20, 2024

Last Update Submit

January 31, 2025

Conditions

Keywords

Ultrasound SWEParkinson disease

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.

Device: Ultrasound shear wave elastography

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

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.

Healthy non Parkinson's groupParkinson's patients group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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: 29883227BACKGROUND
  • 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: 37811009BACKGROUND
  • 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: 33424580BACKGROUND
  • 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: 33924103BACKGROUND
  • 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: 33848468BACKGROUND
  • 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: 34431245BACKGROUND
  • 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: 29056899BACKGROUND
  • 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 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: 19025984BACKGROUND
  • Kim 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: 26686260BACKGROUND
  • Guerra 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: 37366316BACKGROUND
  • Drakonaki 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: 19913130BACKGROUND
  • Kronlage 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

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Afaf A. Hassan

    Professor

    STUDY DIRECTOR
  • Radwa K. Abdel-Naser

    Assistant professor

    STUDY DIRECTOR

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