NCT06200454

Brief Summary

  1. 1.Sensitivity and specificity of cranial neuromuscular US to detect the prognosis of Guillain Barre Syndrome
  2. 2.Correlation of US values with motor, respiratory and autonomic complications of Guillain Barre Syndrome

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2025

Completed
Last Updated

January 11, 2024

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 28, 2023

Last Update Submit

December 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Predictive value of neuromuscular ultrasound of cranial nerves in Guillain-Barré syndrome

    analysis of ultrasound results and follfow up of the cases to see if neuromuscular ultrasound of cranial nerves can predict the prognosis in Guillain-Barré syndrome

    baseline

Study Arms (2)

Guillain-Barré syndrome patients

neuromuscular ultrasound of cranial nerves

Device: neuromuscular ultrasound of cranial nerves

normal participants

neuromuscular ultrasound of cranial nerves

Device: neuromuscular ultrasound of cranial nerves

Interventions

neuromuscular ultrasound of cranial nerves.

Guillain-Barré syndrome patientsnormal participants

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Guillain-Barré syndrome (GBS) is a dangerous and under certain circumstances life-threatening immune-mediated polyneuropathy of acute onset, often subsequent to respiratory or diarrheal illness. Patients usually present with distal onset of slight sensory symptoms such as numbness and tingling followed by ascending weakness of arms and legs, often involving cranial nerves Typical clinical findings are symmetric, flaccid paresis, reduced or absent deep tendon reflexes, and slight sensory symptoms only. Many variants of GBS such as pharyngeal-brachial or bulbar variants exist; the Miller-Fisher syndrome (MFS) with ataxia, areflexia, and oculomotor dysfunction; or the Elsberg syndrome with accentuated involvement of the autonomic nervous system. Diagnosis of GBS is normally based on typical clinical onset, laboratory findings, and electrophysiological studies.

You may qualify if:

  • Patients fulfilling the diagnostic criteria of GBS within the first 2 weeks.
  • Age: 18-65
  • Both sexes

You may not qualify if:

  • Past history of previous similar condition or history suggestive of CIDP.
  • Any proved alternative diagnosis like hypo- or hyperkalemic paralysis, porphyria, or myositis.
  • Other possible causes of peripheral neuropathy, diabetes, renal, and other metabolic disorders.
  • History of Autonomic or cardiopulmonary dysfunction before the onset of symptoms.
  • Patients who refused to participate or sign an informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Wilder-Smith EP. Swollen nerves slimming: Sequential nerve ultrasound in acute Guillain-Barre syndrome. Clin Neurophysiol. 2016 Feb;127(2):1013-1014. doi: 10.1016/j.clinph.2015.07.010. Epub 2015 Jul 17. No abstract available.

    PMID: 26210255BACKGROUND
  • Abdelnaby R, Elsayed M, Mohamed KA, Dardeer KT, Sonbol YT, ELgenidy A, Barakat MH, NasrEldin YK, Maier A. Sonographic Reference Values of Vagus Nerve: A Systematic Review and Meta-analysis. J Clin Neurophysiol. 2022 Jan 1;39(1):59-71. doi: 10.1097/WNP.0000000000000856.

    PMID: 34144573BACKGROUND
  • Guven SC, Bilgin E, Ozcakar L. Ultrasound imaging of the accessory nerve injury in a patient with thrombotic thrombocytopenic purpura and polyneuropathy. Am J Phys Med Rehabil. 2014 Oct;93(10):928. doi: 10.1097/PHM.0000000000000130. No abstract available.

    PMID: 24919085BACKGROUND
  • Curcean AD, Rusu GM, Dudea SM. Ultrasound appearance of peripheral nerves in the neck: vagus, hypoglossal and greater auricular. Med Pharm Rep. 2020 Jan;93(1):39-46. doi: 10.15386/mpr-1273. Epub 2020 Jan 31.

    PMID: 32133445BACKGROUND

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 11, 2024

Study Start

January 8, 2024

Primary Completion

January 8, 2025

Study Completion

June 8, 2025

Last Updated

January 11, 2024

Record last verified: 2023-12