Guillain-Barre SyndromeNCT06200454
Predictive Value of Neuromuscular Ultrasound of Cranial Nerves in Guillain-Barré Syndrome
An observational study of Guillain-Barre Syndrome, run by Assiut University.
Trial summary
1. Sensitivity and specificity of cranial neuromuscular US to detect the prognosis of Guillain Barre Syndrome 2. Correlation of US values with motor, respiratory and autonomic complications of Guillain Barre Syndrome Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Guillain-Barre Syndrome
- What is being tested?
- neuromuscular ultrasound of cranial nerves
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2024to 8 Jun 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients fulfilling the diagnostic criteria of GBS within the first 2 weeks.
- Age: 18-65
- Both sexes
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
- Sensitivity and specificity of cranial neuromuscular US to detect the prognosis of Guillain Barre Syndrome
- Correlation of US values with motor, respiratory and autonomic complications of Guillain Barre Syndrome
Read the detailed description
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.
In literature, Campylobacter jejuni infection is the most commonly identified precipitant of GBS. Cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus (HIV), and Zika virus have also been reported with GBS [5]. A small percentage of patients develop GBS after other triggering events such as immunization, surgery, trauma, and bone-marrow transplantation.
Autonomic dysfunction (AD) in GBS predominantly occurs in the acute phase of the illness but can manifest in the recovery phase too. The exact mechanism remains unknown but probably involves dysfunction in the sympathetic and parasympathetic systems [8].
AD in GBS is observed in 70% of the cases [7]; features including tachycardia, bradycardia, facial flushing, hypertension alternating with hypotension, orthostatic hypotension, anhydrosis or diaphoresis, and urinary retention while gastrointestinal autonomic manifestation includes diarrhea or constipation [9]. Severe autonomic dysfunction is an important factor to recognize and treat accordingly as this is occasionally associated with a sudden death rate of 5-7% [10,11].
Guillain-Barré Syndrome (GBS) is often accompanied by respiratory failure that necessitates mechanical ventilation (MV).1 About 20-30% of cases require respiratory support.2-4 Major complications, including pulmonary infections, sepsis and pulmonary embolism, are reported in 60% of intubated patients with GBS.5, 6 The worldwide mortality rate for ventilated patients ranges from 15% to 30%, with survivors usually having poor outcomes.7 . Multiple clinical and biological parameters have been identified as risk factors for impending respiratory failure in GBS,9, 10 including cranial nerve involvement, disability grade on admission, rapidly progressive motor weakness, an absence of deep tendon reflexes, autonomic dysfunction, and features of nerve conduction block on electromyography.11-14
Facial nerve is commonly involved in GBS, occurring in at least half of patients. Other cranial nerves like bulbar nerves, abducent, oculomotor, optic, hypoglossal nerves are less often affected Ultrasound (US) is a reliable, effective, noninvasive, and well tolerated technique that allows multiple nerves to be examined in a relatively short period. Ultrasound (US) studies have demonstrated patchy enlargement of cranial nerves in Guillain-Barré syndrome (GBS). However, whether ultrasound yields useful information for early classification of GBS has not been established. We aimed to evaluate nerve ultrasound in patients with GBS in assuit university hospital. As confirmed in acquired immune-mediated neuropathies and inherited demyelinating neuropathies peripheral nerves can exhibit quantifiable enlargement in increased cross-sectional areas (CSA).
We follow up the patient to see improvement and accordingly we see the predictive value of neuromuscular ultrasound of cranial nerves in Guillain-Barré syndrome
- Conditions
- Guillain-Barre Syndrome
- Being tested
- neuromuscular ultrasound of cranial nerves
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular ultrasound of cranial nervesDevice
neuromuscular ultrasound of cranial nerves.
| Study group | Role | What they receive |
|---|---|---|
| Guillain-Barré syndrome patients | neuromuscular ultrasound of cranial nerves Receives: Device: neuromuscular ultrasound of cranial nerves | |
| normal participants | neuromuscular ultrasound of cranial nerves Receives: Device: neuromuscular ultrasound of cranial nerves |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start8 Jan 2024 (estimated)
- Primary completion8 Jan 2025 (estimated)
- Study completion8 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Guillain-Barre SyndromeStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed abdallah abdalraziq ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200454
- Sponsor's protocol ID
- U/S of cranial nerves in GBS
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26210255Abdelnaby 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.
PubMed 34144573Guven 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.
PubMed 24919085Curcean 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.
PubMed 32133445
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Neuromuscular Ultrasound of Cranial Nerves in Guillain-Barré Syndrome
- ClinicalTrials.gov ID
- NCT06200454
- Acronym / sponsor ID
- U/S of cranial nerves in GBS
- Conditions
- Guillain-Barre Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 8 Jan 2024 (estimated)
- Primary completion
- 8 Jan 2025 (estimated)
- Study completion
- 8 Jun 2025 (estimated)
- First posted
- 11 Jan 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.
- Sensitivity and specificity of cranial neuromuscular US to detect the prognosis of Guillain Barre Syndrome
- Correlation of US values with motor, respiratory and autonomic complications of Guillain Barre Syndrome
Detailed description
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.
In literature, Campylobacter jejuni infection is the most commonly identified precipitant of GBS. Cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus (HIV), and Zika virus have also been reported with GBS [5]. A small percentage of patients develop GBS after other triggering events such as immunization, surgery, trauma, and bone-marrow transplantation.
Autonomic dysfunction (AD) in GBS predominantly occurs in the acute phase of the illness but can manifest in the recovery phase too. The exact mechanism remains unknown but probably involves dysfunction in the sympathetic and parasympathetic systems [8].
AD in GBS is observed in 70% of the cases [7]; features including tachycardia, bradycardia, facial flushing, hypertension alternating with hypotension, orthostatic hypotension, anhydrosis or diaphoresis, and urinary retention while gastrointestinal autonomic manifestation includes diarrhea or constipation [9]. Severe autonomic dysfunction is an important factor to recognize and treat accordingly as this is occasionally associated with a sudden death rate of 5-7% [10,11].
Guillain-Barré Syndrome (GBS) is often accompanied by respiratory failure that necessitates mechanical ventilation (MV).1 About 20-30% of cases require respiratory support.2-4 Major complications, including pulmonary infections, sepsis and pulmonary embolism, are reported in 60% of intubated patients with GBS.5, 6 The worldwide mortality rate for ventilated patients ranges from 15% to 30%, with survivors usually having poor outcomes.7 . Multiple clinical and biological parameters have been identified as risk factors for impending respiratory failure in GBS,9, 10 including cranial nerve involvement, disability grade on admission, rapidly progressive motor weakness, an absence of deep tendon reflexes, autonomic dysfunction, and features of nerve conduction block on electromyography.11-14
Facial nerve is commonly involved in GBS, occurring in at least half of patients. Other cranial nerves like bulbar nerves, abducent, oculomotor, optic, hypoglossal nerves are less often affected Ultrasound (US) is a reliable, effective, noninvasive, and well tolerated technique that allows multiple nerves to be examined in a relatively short period. Ultrasound (US) studies have demonstrated patchy enlargement of cranial nerves in Guillain-Barré syndrome (GBS). However, whether ultrasound yields useful information for early classification of GBS has not been established. We aimed to evaluate nerve ultrasound in patients with GBS in assuit university hospital. As confirmed in acquired immune-mediated neuropathies and inherited demyelinating neuropathies peripheral nerves can exhibit quantifiable enlargement in increased cross-sectional areas (CSA).
We follow up the patient to see improvement and accordingly we see the predictive value of neuromuscular ultrasound of cranial nerves in Guillain-Barré syndrome
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guillain-Barré syndrome patients | – | Device: neuromuscular ultrasound of cranial nervesneuromuscular ultrasound of cranial nerves |
| normal participants | – | Device: neuromuscular ultrasound of cranial nervesneuromuscular ultrasound of cranial nerves |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients fulfilling the diagnostic criteria of GBS within the first 2 weeks.
- Age: 18-65
- Both sexes
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| neuromuscular ultrasound of cranial nervesneuromuscular ultrasound of cranial nerves. | Device | Guillain-Barré syndrome patients, normal participants |
Primary outcome
Predictive value of neuromuscular ultrasound of cranial nerves in Guillain-Barré syndrome
Time frame: baseline
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 26210255Wilder-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.
- Background: PubMed 34144573Abdelnaby 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.
- Background: PubMed 24919085Guven 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.
- Background: PubMed 32133445Curcean 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.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Guillain-Barre Syndrome, 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 5 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed abdallah, master (01094700462, moha.abdallah4444@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of neuromuscular ultrasound of cranial nerves in Guillain-Barré syndrome (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 NCT06200454, which also lists 4 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 11 Jan 2024.