Guillain-Barre SyndromeNCT05284786
Ultrasonography and Electrophysiology in GBS
An observational study of Guillain-Barre Syndrome, run by Assiut University.
Trial summary
Description of the time course of nerve ultrasonography changes in correlation to nerve conduction studies (NCS) and clinical course. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Guillain-Barre Syndrome
- What is being tested?
- nerve ultrasonography
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Oct 2024
- 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 15 to 60 years
- All sexes
- Child, Adult
Study population: Each patient will be submitted to: Clinical assessment scales, ultrasonography assessment of peripheral nerves together with nerve conduction study will performed in all patient within first two weeks of symptoms onset, after two weeks of IVIG or plasmapheresis treatment and after 3 months as follow up. 1. Comprehensive evaluation at admission with medical history and clinical examination by neurologist. 2. Clinical assessment scales of different variants GBS: 1. The overall disability sum score (ODSS). 2. The Guillain-Barré syndrome disability scale (GDS). 3. Ultra sonographic assessment of peripheral nerves: 4. Nerve conduction studies: NCS were performed in the corresponding nerves using a standard electro-neurophysiologic device.
Who may be able to join
- Patients newly diagnosed as Guillain Barre Syndrome using diagnostic criteria for GBS.
- Patients from both sex and at any age group with recent onset of GBS.
Who cannot join
- Patients with other possible causes of peripheral neuropathy, diabetes, renal, metabolic and others
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasonographic and Electrophysiological Follow up of Patients With Guillain Barre Syndrome Before and After Treatment
Description of the time course of nerve ultrasonography changes in correlation to nerve conduction studies (NCS) and clinical course.
Read the detailed description
GBS is an acute- or subacute-onset polyradiculoneuropathy that often follows an upper or lower respiratory illness or gastroenteritis by 10 to 14 days. Approximately 70% of patients can identify a preceding illness, although it is often benign and may be minimized or forgotten by the patient.
GBS evolves over days, often beginning with numbness in the lower limbs and weakness in the same distribution. The progression of symptoms, particularly weakness, can be rapid, resulting in quadriplegia within a few days. About 50% of patients develop some degree of facial weakness. Weakness attributed to other cranial nerves includes ocular dysmotility, pupillary changes, and ptosis. Thirty percent of patients with GBS develop respiratory failure from phrenic nerve disease, requiring intubation and ventilation. Autonomic involvement is common in GBS, with the most common manifestations being tachycardia, bradycardia, hypertension and hypotension, gastric hypomotility, and urinary retention.
Evidence-based research supports the use of immunotherapy for GBS; proven therapies are IV immunoglobulin (IVIg) and plasma exchange, which have been shown to be equally efficacious in the management of GBS.
At present, no biomarkers exist in the blood, urine, or CSF that confirm the diagnosis of GBS. Most patients with GBS will have an elevated CSF protein, but this laboratory finding may not be present until 3 weeks after the onset of the illness. Nerve conduction studies (NCS) play an important role in support GBS diagnosis and subtype classification. In the first few days of the illness, nerve conduction studies may be normal or only show subtle changes of demyelination, such as prolonged or absent F waves and H reflexes, and patchy changes in distal latencies in patients with AIDP.
More recently, there has been a rise in the use of peripheral nerve ultrasound (US) in the investigation of peripheral neuropathies. Whilst nerve conduction studies (NCS) are helpful at providing information on the function of nerves, US is able to provide information on nerve morphology. The value of nerve ultrasonography (NUS) in immune-mediated polyneuropathies is well described in the previous studies. In post-GBS patients patchy and slight enlargements have been reported. Whereas in acute stage cervical spinal nerve enlargement and hypertrophy of the vagus are probably the most obvious findings. However, only little is known about the course of nerve morphology from onset until clinical recovery.
- Conditions
- Guillain-Barre Syndrome
- Being tested
- nerve ultrasonography
- 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.
nerve ultrasonographyDevice
Ultrasonography of different nerves was performed using a high frequency 18 MHz probe (esaote Ultrasound systems). Each nerve was scanned in axial plane, and the cross-sectional area (CSA) was measured at standardized anatomical points, in brief: median nerve in upper arm, elbow, forearm; ulnar nerve in upper arm and forearm; tibial nerve in popliteal and ankle; peroneal nerve in popliteal fossa, sural nerve in the calf and the vagus nerve.
What is being measured
The primary outcome is the main question the study is designed to answer.
significance of ultrasonography nerve assessement in follow up of course of the disease
Uses of ultrasonography as an investigatory tool for assessment of changes occur in the nerves over course of disease. Changes in nerves detected by ultrasonography might be an early marker in GBS and support diagnosis of disease in early phase. Also, there are some characteristic differences in ultra-sonographic nerve changes between GBS and CIDP and as known about 15-20% of cases of CIDP are presented with acute onset similar to GBS making an ultrasound can be used as prognostic tool in identification of cases with acute onset CIDP that presented with similar picture of GBS
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohammed Galal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284786
- Sponsor's protocol ID
- ultrasonography in GBS
- Status last verified
- Jun 2022
- First submitted
- 9 Mar 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Esposito S, Longo MR. Guillain-Barre syndrome. Autoimmun Rev. 2017 Jan;16(1):96-101. doi: 10.1016/j.autrev.2016.09.022. Epub 2016 Sep 23.
PubMed 27666816van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barre syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-82. doi: 10.1038/nrneurol.2014.121. Epub 2014 Jul 15.
PubMed 25023340Willison HJ, Jacobs BC, van Doorn PA. Guillain-Barre syndrome. Lancet. 2016 Aug 13;388(10045):717-27. doi: 10.1016/S0140-6736(16)00339-1. Epub 2016 Mar 2.
PubMed 26948435Asbury AK, Cornblath DR. Assessment of current diagnostic criteria for Guillain-Barre syndrome. Ann Neurol. 1990;27 Suppl:S21-4. doi: 10.1002/ana.410270707.
PubMed 2194422Hadden RD, Cornblath DR, Hughes RA, Zielasek J, Hartung HP, Toyka KV, Swan AV. Electrophysiological classification of Guillain-Barre syndrome: clinical associations and outcome. Plasma Exchange/Sandoglobulin Guillain-Barre Syndrome Trial Group. Ann Neurol. 1998 Nov;44(5):780-8. doi: 10.1002/ana.410440512.
PubMed 9818934Uncini A, Kuwabara S. The electrodiagnosis of Guillain-Barre syndrome subtypes: Where do we stand? Clin Neurophysiol. 2018 Dec;129(12):2586-2593. doi: 10.1016/j.clinph.2018.09.025. Epub 2018 Oct 28.
PubMed 30419502Rajabally YA, Hiew FL, Winer JB. Influence of timing on electrodiagnosis of Guillain-Barre syndrome in the first six weeks: a retrospective study. J Neurol Sci. 2015 Oct 15;357(1-2):143-5. doi: 10.1016/j.jns.2015.07.018. Epub 2015 Jul 14.
PubMed 26194045Gallardo E, Noto Y, Simon NG. Ultrasound in the diagnosis of peripheral neuropathy: structure meets function in the neuromuscular clinic. J Neurol Neurosurg Psychiatry. 2015 Oct;86(10):1066-74. doi: 10.1136/jnnp-2014-309599. Epub 2015 Feb 4.
PubMed 25653385Gallardo E, Sedano MJ, Orizaola P, Sanchez-Juan P, Gonzalez-Suarez A, Garcia A, Teran-Villagra N, Ruiz-Soto M, Alvaro RL, Berciano MT, Lafarga M, Berciano J. Spinal nerve involvement in early Guillain-Barre syndrome: a clinico-electrophysiological, ultrasonographic and pathological study. Clin Neurophysiol. 2015 Apr;126(4):810-9. doi: 10.1016/j.clinph.2014.06.051. Epub 2014 Aug 21.
PubMed 25213352Kerasnoudis A, Pitarokoili K, Behrendt V, Gold R, Yoon MS. Correlation of nerve ultrasound, electrophysiological, and clinical findings in post Guillain-Barre syndrome. J Peripher Nerv Syst. 2013 Sep;18(3):232-40. doi: 10.1111/jns5.12037.
PubMed 24028191Kerasnoudis A, Pitarokoili K, Behrendt V, Gold R, Yoon MS. Nerve ultrasound score in distinguishing chronic from acute inflammatory demyelinating polyneuropathy. Clin Neurophysiol. 2014 Mar;125(3):635-41. doi: 10.1016/j.clinph.2013.08.014. Epub 2013 Sep 23.
PubMed 24070674Scheidl E, Bohm J, Simo M, Bereznai B, Bereczki D, Aranyi Z. Different patterns of nerve enlargement in polyneuropathy subtypes as detected by ultrasonography. Ultrasound Med Biol. 2014 Jun;40(6):1138-45. doi: 10.1016/j.ultrasmedbio.2013.12.020. Epub 2014 Mar 5.
PubMed 24613217Zaidman CM, Al-Lozi M, Pestronk A. Peripheral nerve size in normals and patients with polyneuropathy: an ultrasound study. Muscle Nerve. 2009 Dec;40(6):960-6. doi: 10.1002/mus.21431.
PubMed 19697380Grimm A, Decard BF, Axer H. Ultrasonography of the peripheral nervous system in the early stage of Guillain-Barre syndrome. J Peripher Nerv Syst. 2014 Sep;19(3):234-41. doi: 10.1111/jns.12091.
PubMed 25418824
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic and Electrophysiological Follow up of Patients With Guillain Barre Syndrome Before and After Treatment
- ClinicalTrials.gov ID
- NCT05284786
- Acronym / sponsor ID
- ultrasonography in GBS
- Conditions
- Guillain-Barre Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 17 Mar 2022 (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.
Description of the time course of nerve ultrasonography changes in correlation to nerve conduction studies (NCS) and clinical course.
Detailed description
GBS is an acute- or subacute-onset polyradiculoneuropathy that often follows an upper or lower respiratory illness or gastroenteritis by 10 to 14 days. Approximately 70% of patients can identify a preceding illness, although it is often benign and may be minimized or forgotten by the patient.
GBS evolves over days, often beginning with numbness in the lower limbs and weakness in the same distribution. The progression of symptoms, particularly weakness, can be rapid, resulting in quadriplegia within a few days. About 50% of patients develop some degree of facial weakness. Weakness attributed to other cranial nerves includes ocular dysmotility, pupillary changes, and ptosis. Thirty percent of patients with GBS develop respiratory failure from phrenic nerve disease, requiring intubation and ventilation. Autonomic involvement is common in GBS, with the most common manifestations being tachycardia, bradycardia, hypertension and hypotension, gastric hypomotility, and urinary retention.
Evidence-based research supports the use of immunotherapy for GBS; proven therapies are IV immunoglobulin (IVIg) and plasma exchange, which have been shown to be equally efficacious in the management of GBS.
At present, no biomarkers exist in the blood, urine, or CSF that confirm the diagnosis of GBS. Most patients with GBS will have an elevated CSF protein, but this laboratory finding may not be present until 3 weeks after the onset of the illness. Nerve conduction studies (NCS) play an important role in support GBS diagnosis and subtype classification. In the first few days of the illness, nerve conduction studies may be normal or only show subtle changes of demyelination, such as prolonged or absent F waves and H reflexes, and patchy changes in distal latencies in patients with AIDP.
More recently, there has been a rise in the use of peripheral nerve ultrasound (US) in the investigation of peripheral neuropathies. Whilst nerve conduction studies (NCS) are helpful at providing information on the function of nerves, US is able to provide information on nerve morphology. The value of nerve ultrasonography (NUS) in immune-mediated polyneuropathies is well described in the previous studies. In post-GBS patients patchy and slight enlargements have been reported. Whereas in acute stage cervical spinal nerve enlargement and hypertrophy of the vagus are probably the most obvious findings. However, only little is known about the course of nerve morphology from onset until clinical recovery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Each patient will be submitted to: Clinical assessment scales, ultrasonography assessment of peripheral nerves together with nerve conduction study will performed in all patient within first two weeks of symptoms onset, after two weeks of IVIG or plasmapheresis treatment and after 3 months as follow up. 1. Comprehensive evaluation at admission with medical history and clinical examination by neurologist. 2. Clinical assessment scales of different variants GBS: 1. The overall disability sum score (ODSS). 2. The Guillain-Barré syndrome disability scale (GDS). 3. Ultra sonographic assessment of peripheral nerves: 4. Nerve conduction studies: NCS were performed in the corresponding nerves using a standard electro-neurophysiologic device.
Key inclusion criteria (2 listed)
- Patients newly diagnosed as Guillain Barre Syndrome using diagnostic criteria for GBS.
- Patients from both sex and at any age group with recent onset of GBS.
Key exclusion criteria (1 listed)
- Patients with other possible causes of peripheral neuropathy, diabetes, renal, metabolic and others
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 |
|---|---|---|
| nerve ultrasonographyUltrasonography of different nerves was performed using a high frequency 18 MHz probe (esaote Ultrasound systems). Each nerve was scanned in axial plane, and the cross-sectional area (CSA) was measured at standardized anatomical points, in brief: median nerve in upper arm, elbow, forearm; ulnar nerve in upper arm and forearm; tibial nerve in popliteal and ankle; peroneal nerve in popliteal fossa, sural nerve in the calf and the vagus nerve. | Device | – |
Primary outcome
significance of ultrasonography nerve assessement in follow up of course of the disease
Time frame: Baseline
Uses of ultrasonography as an investigatory tool for assessment of changes occur in the nerves over course of disease. Changes in nerves detected by ultrasonography might be an early marker in GBS and support diagnosis of disease in early phase. Also, there are some characteristic differences in ultra-sonographic nerve changes between GBS and CIDP and as known about 15-20% of cases of CIDP are presented with acute onset similar to GBS making an ultrasound can be used as prognostic tool in identification of cases with acute onset CIDP that presented with similar picture of GBS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Background: PubMed 27666816Esposito S, Longo MR. Guillain-Barre syndrome. Autoimmun Rev. 2017 Jan;16(1):96-101. doi: 10.1016/j.autrev.2016.09.022. Epub 2016 Sep 23.
- Background: PubMed 25023340van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barre syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-82. doi: 10.1038/nrneurol.2014.121. Epub 2014 Jul 15.
- Background: PubMed 26948435Willison HJ, Jacobs BC, van Doorn PA. Guillain-Barre syndrome. Lancet. 2016 Aug 13;388(10045):717-27. doi: 10.1016/S0140-6736(16)00339-1. Epub 2016 Mar 2.
- Background: PubMed 2194422Asbury AK, Cornblath DR. Assessment of current diagnostic criteria for Guillain-Barre syndrome. Ann Neurol. 1990;27 Suppl:S21-4. doi: 10.1002/ana.410270707.
- Background: PubMed 9818934Hadden RD, Cornblath DR, Hughes RA, Zielasek J, Hartung HP, Toyka KV, Swan AV. Electrophysiological classification of Guillain-Barre syndrome: clinical associations and outcome. Plasma Exchange/Sandoglobulin Guillain-Barre Syndrome Trial Group. Ann Neurol. 1998 Nov;44(5):780-8. doi: 10.1002/ana.410440512.
- Background: PubMed 30419502Uncini A, Kuwabara S. The electrodiagnosis of Guillain-Barre syndrome subtypes: Where do we stand? Clin Neurophysiol. 2018 Dec;129(12):2586-2593. doi: 10.1016/j.clinph.2018.09.025. Epub 2018 Oct 28.
- Background: PubMed 26194045Rajabally YA, Hiew FL, Winer JB. Influence of timing on electrodiagnosis of Guillain-Barre syndrome in the first six weeks: a retrospective study. J Neurol Sci. 2015 Oct 15;357(1-2):143-5. doi: 10.1016/j.jns.2015.07.018. Epub 2015 Jul 14.
- Background: PubMed 25653385Gallardo E, Noto Y, Simon NG. Ultrasound in the diagnosis of peripheral neuropathy: structure meets function in the neuromuscular clinic. J Neurol Neurosurg Psychiatry. 2015 Oct;86(10):1066-74. doi: 10.1136/jnnp-2014-309599. Epub 2015 Feb 4.
- Background: PubMed 25213352Gallardo E, Sedano MJ, Orizaola P, Sanchez-Juan P, Gonzalez-Suarez A, Garcia A, Teran-Villagra N, Ruiz-Soto M, Alvaro RL, Berciano MT, Lafarga M, Berciano J. Spinal nerve involvement in early Guillain-Barre syndrome: a clinico-electrophysiological, ultrasonographic and pathological study. Clin Neurophysiol. 2015 Apr;126(4):810-9. doi: 10.1016/j.clinph.2014.06.051. Epub 2014 Aug 21.
- Background: PubMed 24028191Kerasnoudis A, Pitarokoili K, Behrendt V, Gold R, Yoon MS. Correlation of nerve ultrasound, electrophysiological, and clinical findings in post Guillain-Barre syndrome. J Peripher Nerv Syst. 2013 Sep;18(3):232-40. doi: 10.1111/jns5.12037.
- Background: PubMed 24070674Kerasnoudis A, Pitarokoili K, Behrendt V, Gold R, Yoon MS. Nerve ultrasound score in distinguishing chronic from acute inflammatory demyelinating polyneuropathy. Clin Neurophysiol. 2014 Mar;125(3):635-41. doi: 10.1016/j.clinph.2013.08.014. Epub 2013 Sep 23.
- Background: PubMed 24613217Scheidl E, Bohm J, Simo M, Bereznai B, Bereczki D, Aranyi Z. Different patterns of nerve enlargement in polyneuropathy subtypes as detected by ultrasonography. Ultrasound Med Biol. 2014 Jun;40(6):1138-45. doi: 10.1016/j.ultrasmedbio.2013.12.020. Epub 2014 Mar 5.
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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 2 inclusion and 1 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 7 Jun 2022. 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 Amr Galal, specialist (01027494997, amrgalal866@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significance of ultrasonography nerve assessement in follow up of course of the disease (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 NCT05284786, which also lists 14 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 7 Jun 2022.