ParkinsonismNCT05834634
Ultrasound Changes of the Vagus Nerve in Patients With Parkinsonism
An observational study of Parkinsonism, run by Assiut University at 1 site in Egypt.
Trial summary
In this study, the investigators will assess the Vagus nerve in two groups: Group 1 which include patients with parkinsonism and group 2 which included age and sex matched healthy control. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinsonism
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Patients diagnosed with Parkinsonism including Parkinsons disease diagnosed according to the criteria of the UK British Brain Bank (21) and successive revision (22) attending the neurology outpatient clinic, Department of Neurology and Psychiatry, Assiut University hospital. * Age and sex matched healthy control group, will be recruited from the outpatient
- Inclusion Criteria:
- All patients fulfill the criteria of case definition of parkinsonism.
- Gender: both sexes are included.
- Willingness to participate in the study and to be subjected to the disease-related examinations and assessments.
- Willing and able to provide informed consent.
- Exclusion Criteria:
- Patients unable to give informed consent.
- History of chronic psychiatric or other central nervous system pathology and other neurodegenerative disorder(s).
- Patients with previous surgery in proximity of the Vagus nerve (for example carotid endarterectomy or implantation of Vagus nerve stimulator).
- Patients with known systemic diseases (such as diabetes mellitus, vascular disease, and peripheral neuropathy).
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the investigators will assess the Vagus nerve in two groups: Group 1 which include patients with parkinsonism and group 2 which included age and sex matched healthy control. The aim of the study is: detecting the difference between both groups and correlating the changes in the Vagus nerve cross sectional area with the motor and non motor manifestations of parkinsonism
Read the detailed description
Parkinsonism is a syndrome characterized by the presence of six cardinal motor characteristics: resting tremor, rigidity, bradykinesia, loss of postural reflexes, flexed posture, and freezing. These combined symptoms identify clinically definite, probable, and possible parkinsonism (1). The most common form of parkinsonism is Parkinson's disease (PD) (1). Other forms of parkinsonism included atypical parkinsonism as progressive supranuclear palsy (PSP), multiple system atrophy (MSA), and corticobasal syndrome (CBS). The former types of parkinsonism are neurodegenerative disorders. Vascular parkinsonism (VP) is another form attributed to vascular etiology (2).
PD is the second-most common neurodegenerative disorder that affects 2-3% of the population ≥65 years of age. The main manifestation of PD is a clinical hypokinetic rigid syndrome. Also, numerous non-motor symptoms (NMS), including autonomic symptoms, such as orthostatic hypotension, constipation and urinary incontinence, have been suggested as preclinical symptoms (3). Other NMS include sleep alterations, dementia, depression, and pain that may severely compromise the quality of life (4).
The main neuropathologic hallmark is the formation of cytoplasmic inclusions called α-synuclein-enriched Lewy bodies and Lewy neurites. These aggregations are found throughout the brain, most pronounced in the substantia nigra compacta (5, 6). Also, these aggregations are present in the peripheral nervous system, more specifically in the Vagus nerve, which plays a vital role in autonomic control (7, 8). In addition, the Vagus nerve may play a crucial role in PD pathogenesis as it was hypothesized that α-synuclein aggregates form in the enteric nervous system and spread to the CNS via the autonomic nervous system (9).
Neuromuscular ultrasound is a non-invasive tool that can visualize nerves and roots with high resolution and accuracy (10). A recent systematic review reported that in PD, there is a degree of Vagus nerve atrophy that may be detected by ultrasound; therefore, it can be utilized as a marker for Vagus nerve lesions. However, correlation studies are lacking between the findings and clinical manifestations of parkinsonism (11).
Several studies were conducted to examine vagal neuron loss by ultrasonography, but they reported contradictory results. For example, some studies discovered considerable atrophy of the Vagus nerves in PD patients (12-15). However, other studies found no difference between PD patients and healthy controls (16-19). In addition, the link between Vagus nerve atrophy and other atypical parkinsonism, MSA, PSP, and CBS has not been extensively studied (20).
The present study aims to detect ultrasound changes in the Vagus nerve in patients with parkinsonism, compare the findings with healthy control, and correlate these changes with the motor and non-motor manifestations.
- Conditions
- Parkinsonism
- Being tested
- Ultrasound
- Keywords
- Vagus nerve, Parkinsonism, Nerve ultrasound
- Medical subject headings
- Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
The patients and controls will be scanned at the Neurophysiology unit of the Department of Neurology, Neurology, psychiatry and Neurosurgery hospital, Assiut university hospital. The acquisition of ultrasound images was performed using a Philips HD11XE imaging system with an L12-8 linear array probe. Cross-sectional area (CSA) of the right and left Vagus nerves in each subject, perimeter, echogenicity, and fascicular structure will be assessed and measured by tracing the nerve just inside its hyperechoic rim. The nerve will be seen on ultrasound B-mode near the bifurcation of the carotid artery, dorsal to the internal and common carotid arteries, as a structure that is hypoechogenic in the centre and more hyperechogenic on the periphery (24, 25). Both the carotid artery and the internal jugular vein served as anatomical landmarks (25). Two separate CSA measurements, with the probe repositioned for each measurement, will be taken and they will be averaged.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with parkinsonism Receives: Device: Ultrasound | |
| Group 2 | Healthy age and sex matched controls Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing vagus nerve diameter between healthy controls and patients with parkinsonism
Detecting the ultrasound changes in Vagus nerve in patients with parkinsonism in comparison to age and sex matched healthy control.
Measured: 1 day
Secondary outcomes (1)
Correlation of the Vagus nerve ultrasound changes with the motor and non-motor manifestations of parkinsonism
Identifying the correlation of the Vagus nerve ultrasound changes with the motor and non-motor manifestations in patients with parkinsonism
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourelhoda Ahmed Ahmed Haridy, Assiut University
- Investigators
- Mohamed AR Ahmed, Principal investigator, Assiut UniversityNourelhoda AA Haridy, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834634
- Sponsor's protocol ID
- Ultrasound of vagus nerve
- Status last verified
- Feb 2024
- First submitted
- 18 Apr 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Changes of the Vagus Nerve in Patients With Parkinsonism
- ClinicalTrials.gov ID
- NCT05834634
- Acronym / sponsor ID
- Ultrasound of vagus nerve
- Conditions
- Parkinsonism
- Keywords
- Vagus nerve, Parkinsonism, Nerve ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 28 Apr 2023 (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.
In this study, the investigators will assess the Vagus nerve in two groups: Group 1 which include patients with parkinsonism and group 2 which included age and sex matched healthy control. The aim of the study is: detecting the difference between both groups and correlating the changes in the Vagus nerve cross sectional area with the motor and non motor manifestations of parkinsonism
Detailed description
Parkinsonism is a syndrome characterized by the presence of six cardinal motor characteristics: resting tremor, rigidity, bradykinesia, loss of postural reflexes, flexed posture, and freezing. These combined symptoms identify clinically definite, probable, and possible parkinsonism (1). The most common form of parkinsonism is Parkinson's disease (PD) (1). Other forms of parkinsonism included atypical parkinsonism as progressive supranuclear palsy (PSP), multiple system atrophy (MSA), and corticobasal syndrome (CBS). The former types of parkinsonism are neurodegenerative disorders. Vascular parkinsonism (VP) is another form attributed to vascular etiology (2).
PD is the second-most common neurodegenerative disorder that affects 2-3% of the population ≥65 years of age. The main manifestation of PD is a clinical hypokinetic rigid syndrome. Also, numerous non-motor symptoms (NMS), including autonomic symptoms, such as orthostatic hypotension, constipation and urinary incontinence, have been suggested as preclinical symptoms (3). Other NMS include sleep alterations, dementia, depression, and pain that may severely compromise the quality of life (4).
The main neuropathologic hallmark is the formation of cytoplasmic inclusions called α-synuclein-enriched Lewy bodies and Lewy neurites. These aggregations are found throughout the brain, most pronounced in the substantia nigra compacta (5, 6). Also, these aggregations are present in the peripheral nervous system, more specifically in the Vagus nerve, which plays a vital role in autonomic control (7, 8). In addition, the Vagus nerve may play a crucial role in PD pathogenesis as it was hypothesized that α-synuclein aggregates form in the enteric nervous system and spread to the CNS via the autonomic nervous system (9).
Neuromuscular ultrasound is a non-invasive tool that can visualize nerves and roots with high resolution and accuracy (10). A recent systematic review reported that in PD, there is a degree of Vagus nerve atrophy that may be detected by ultrasound; therefore, it can be utilized as a marker for Vagus nerve lesions. However, correlation studies are lacking between the findings and clinical manifestations of parkinsonism (11).
Several studies were conducted to examine vagal neuron loss by ultrasonography, but they reported contradictory results. For example, some studies discovered considerable atrophy of the Vagus nerves in PD patients (12-15). However, other studies found no difference between PD patients and healthy controls (16-19). In addition, the link between Vagus nerve atrophy and other atypical parkinsonism, MSA, PSP, and CBS has not been extensively studied (20).
The present study aims to detect ultrasound changes in the Vagus nerve in patients with parkinsonism, compare the findings with healthy control, and correlate these changes with the motor and non-motor manifestations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: UltrasoundPatients with parkinsonism |
| Group 2 | – | Device: UltrasoundHealthy age and sex matched controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patients diagnosed with Parkinsonism including Parkinsons disease diagnosed according to the criteria of the UK British Brain Bank (21) and successive revision (22) attending the neurology outpatient clinic, Department of Neurology and Psychiatry, Assiut University hospital. * Age and sex matched healthy control group, will be recruited from the outpatient
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 |
|---|---|---|
| UltrasoundThe patients and controls will be scanned at the Neurophysiology unit of the Department of Neurology, Neurology, psychiatry and Neurosurgery hospital, Assiut university hospital. The acquisition of ultrasound images was performed using a Philips HD11XE imaging system with an L12-8 linear array probe. Cross-sectional area (CSA) of the right and left Vagus nerves in each subject, perimeter, echogenicity, and fascicular structure will be assessed and measured by tracing the nerve just inside its hyperechoic rim. The nerve will be seen on ultrasound B-mode near the bifurcation of the carotid artery, dorsal to the internal and common carotid arteries, as a structure that is hypoechogenic in the centre and more hyperechogenic on the periphery (24, 25). Both the carotid artery and the internal jugular vein served as anatomical landmarks (25). Two separate CSA measurements, with the probe repositioned for each measurement, will be taken and they will be averaged. | Device | Group 1, Group 2 |
Primary outcome
Comparing vagus nerve diameter between healthy controls and patients with parkinsonism
Time frame: 1 day
Detecting the ultrasound changes in Vagus nerve in patients with parkinsonism in comparison to age and sex matched healthy control.
1 secondary outcome
Correlation of the Vagus nerve ultrasound changes with the motor and non-motor manifestations of parkinsonism
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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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. This study is not recruiting at the moment.
Mohamed AR Ahmed principal investigator
Assiut University
Nourelhoda AA Haridy principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinsonism, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Abdeltawab (01092346044, ahmad.mo.abdultawab996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing vagus nerve diameter between healthy controls and patients with parkinsonism (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2024.