Parkinson DiseaseNCT06701318
Ultrasound Shear Wave Elastography in Parkinson's Disease
An observational study of Parkinson Disease, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Ultrasound shear wave elastography
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Adult, Older adult
Study population: Any patients diagnosed with Parkinson's disease and meeting the eligibility criteria.
Who may be able to join
- patient diagnosed with Parkinson's disease
- Age between 40-85 years
- No other neurological or musculoskeletal disorders affecting the examined limb muscles.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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 .
Read the 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 .
- Conditions
- Parkinson Disease
- Being tested
- Ultrasound shear wave elastography
- Keywords
- Ultrasound SWE, Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound shear wave elastographyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Ultrasound shear wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Correlation of the measured muscle stiffness with clinical severity of Parkinson's disease.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study startFeb 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romany Kamal Farah, Assiut University
- Investigators
- Afaf A. Hassan, Study director, ProfessorRadwa K. Abdel-Naser, Study director, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701318
- Sponsor's protocol ID
- Ultrasound SWE in Parkinson's
- Status last verified
- Jan 2025
- First submitted
- 20 Nov 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29883227Prajjwal 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.
PubMed 37811009Cui 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.
PubMed 33424580Church FC. Treatment Options for Motor and Non-Motor Symptoms of Parkinson's Disease. Biomolecules. 2021 Apr 20;11(4):612. doi: 10.3390/biom11040612.
PubMed 33924103Bloem 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.
PubMed 33848468Yin 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.
PubMed 34431245Rovini 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.
PubMed 29056899Goetz 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.
PubMed 19025984Kim 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.
PubMed 26686260Guerra 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.
PubMed 37366316Drakonaki 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.
PubMed 19913130Kronlage 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.
PubMed 33498617
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Shear Wave Elastography for Assessing Muscle Stiffness in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT06701318
- Acronym / sponsor ID
- Ultrasound SWE in Parkinson's
- Conditions
- Parkinson Disease
- Keywords
- Ultrasound SWE, Parkinson disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's patients group | – | Device: Ultrasound shear wave elastographyParkinson'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 | – | Device: Ultrasound shear wave elastographyHealthy 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any patients diagnosed with Parkinson's disease and meeting the eligibility criteria.
Key inclusion criteria (3 listed)
- patient diagnosed with Parkinson's disease
- Age between 40-85 years
- No other neurological or musculoskeletal disorders affecting the examined limb muscles.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound shear wave elastographyAn 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. | Device | Healthy non Parkinson's group, Parkinson's patients group |
Primary outcome
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.
1 secondary outcome
Correlation of the measured muscle stiffness with clinical severity of Parkinson's disease.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Background: PubMed 29883227Khan 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.
- Background: PubMed 37811009Prajjwal 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.
- Background: PubMed 33424580Cui 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.
- Background: PubMed 33924103Church FC. Treatment Options for Motor and Non-Motor Symptoms of Parkinson's Disease. Biomolecules. 2021 Apr 20;11(4):612. doi: 10.3390/biom11040612.
- Background: PubMed 33848468Bloem 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.
- Background: PubMed 34431245Yin 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.
- Background: PubMed 29056899Rovini 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.
- Background: PubMed 19025984Goetz 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.
- Background: PubMed 26686260Kim 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.
- Background: PubMed 37366316Guerra 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.
- Background: PubMed 19913130Drakonaki 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.
- Background: PubMed 33498617Kronlage 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Afaf A. Hassan study director
Professor
Radwa K. Abdel-Naser study director
Assistant professor
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romany K. Farah (+201271461514, romany.16266079@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of muscle stiffness in the study groups. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06701318, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.