AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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

  1. 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.
  1. 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.

Egypt1 site, 1 recruiting
  • Assiut University

    Asyut

    Recruiting

Other trials in Egypt

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 groups in NCT05834634
Study groupRoleWhat they receive
Group 1Patients with parkinsonism
Receives: Device: Ultrasound
Group 2Healthy 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.

  1. 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)
  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.

  1. First posted28 Apr 2023
  2. Study start1 Dec 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in