Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT06701318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-03
First Post:
2024-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Shear Wave Elastography in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2024-11-20', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantification of muscle stiffness in the study groups.', 'timeFrame': 'Baseline', 'description': "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."}], 'secondaryOutcomes': [{'measure': "Correlation of the measured muscle stiffness with clinical severity of Parkinson's disease.", 'timeFrame': 'Baseline', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound SWE', 'Parkinson disease'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '29883227', 'type': 'BACKGROUND', 'citation': "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': '37811009', 'type': 'BACKGROUND', 'citation': "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': '33424580', 'type': 'BACKGROUND', 'citation': "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': '33924103', 'type': 'BACKGROUND', 'citation': "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': '33848468', 'type': 'BACKGROUND', 'citation': "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': '34431245', 'type': 'BACKGROUND', 'citation': "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': '29056899', 'type': 'BACKGROUND', 'citation': "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': '19025984', 'type': 'BACKGROUND', 'citation': "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': '26686260', 'type': 'BACKGROUND', 'citation': "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': '37366316', 'type': 'BACKGROUND', 'citation': "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': '19913130', 'type': 'BACKGROUND', 'citation': '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': '33498617', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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 .", 'detailedDescription': "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 .\n\nMuscle 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 .\n\nTraditionally, 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 .\n\nTools 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 ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Any patients diagnosed with Parkinson's disease and meeting the eligibility criteria.", 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient diagnosed with Parkinson's disease\n* Age between 40-85 years\n* No other neurological or musculoskeletal disorders affecting the examined limb muscles.\n\nExclusion Criteria:\n\n* History of other neurological or musculoskeletal disorders affecting the examined limb muscles.\n* History of significant trauma or surgery in the examined limb within the last year.\n* patients with contraindications to ultrasound( such as open skin wounds or severe skin conditions in the area of interest)."}, 'identificationModule': {'nctId': 'NCT06701318', 'briefTitle': "Ultrasound Shear Wave Elastography in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': "Ultrasound Shear Wave Elastography for Assessing Muscle Stiffness in Parkinson's Disease Patients", 'orgStudyIdInfo': {'id': "Ultrasound SWE in Parkinson's"}}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's patients group", 'description': "Parkinson's disease diagnosed patients who meet the eligibility criteria and not complain of other neurological or musculoskeletal diseases that can affect muscle stiffness.", 'interventionNames': ['Device: Ultrasound shear wave elastography']}, {'label': "Healthy non Parkinson's group", 'description': "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.", 'interventionNames': ['Device: Ultrasound shear wave elastography']}], 'interventions': [{'name': 'Ultrasound shear wave elastography', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ["Healthy non Parkinson's group", "Parkinson's patients group"]}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Romany K. Farah', 'role': 'CONTACT', 'email': 'romany.16266079@med.aun.edu.eg', 'phone': '+201271461514'}], 'overallOfficials': [{'name': 'Afaf A. Hassan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor'}, {'name': 'Radwa K. Abdel-Naser', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Romany Kamal Farah', 'investigatorAffiliation': 'Assiut University'}}}}