Ultrasound Changes of the Vagus Nerve in Patients With Parkinsonism

NCT05834634 | Recruiting

• 1 other identifier: Ultrasound of vagus nerve
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Parkinsonism

Keywords

Vagus nerve; Parkinsonism; Nerve ultrasound

Outcome Measures

Primary Outcomes (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.

  1 day

Secondary Outcomes (1)

• Correlation of the Vagus nerve ultrasound changes with the motor and non-motor manifestations of parkinsonism

  1 day

Study Arms (2)

Group 1

Patients with parkinsonism

Device: Ultrasound

Group 2

Healthy age and sex matched controls

Device: Ultrasound

Interventions

Ultrasound DEVICE

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.

Group 1; Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Parkinsonian Disorders

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mohamed AR Ahmed

  Assiut University

  PRINCIPAL INVESTIGATOR

• Nourelhoda AA Haridy

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Abdeltawab

CONTACT

01092346044; ahmad.mo.abdultawab996@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

EG (1)