Ultrasonography and Electrophysiology in GBS
Ultrasonographic and Electrophysiological Follow up of Patients With Guillain Barre Syndrome Before and After Treatment
1 other identifier
observational
45
0 countries
N/A
Brief Summary
Description of the time course of nerve ultrasonography changes in correlation to nerve conduction studies (NCS) and clinical course.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2022
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedJune 7, 2022
June 1, 2022
2 years
March 9, 2022
June 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Baseline
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients with other possible causes of peripheral neuropathy, diabetes, renal, metabolic and others
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (14)
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.
PMID: 27666816BACKGROUNDvan 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.
PMID: 25023340BACKGROUNDWillison 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.
PMID: 26948435BACKGROUNDAsbury AK, Cornblath DR. Assessment of current diagnostic criteria for Guillain-Barre syndrome. Ann Neurol. 1990;27 Suppl:S21-4. doi: 10.1002/ana.410270707.
PMID: 2194422BACKGROUNDHadden 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.
PMID: 9818934BACKGROUNDUncini 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.
PMID: 30419502BACKGROUNDRajabally 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.
PMID: 26194045BACKGROUNDGallardo 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.
PMID: 25653385BACKGROUNDGallardo 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.
PMID: 25213352BACKGROUNDKerasnoudis 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.
PMID: 24028191BACKGROUNDKerasnoudis 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.
PMID: 24070674BACKGROUNDScheidl 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.
PMID: 24613217BACKGROUNDZaidman 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.
PMID: 19697380BACKGROUNDGrimm 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.
PMID: 25418824BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- specialist
Study Record Dates
First Submitted
March 9, 2022
First Posted
March 17, 2022
Study Start
July 1, 2022
Primary Completion
July 1, 2024
Study Completion
October 1, 2024
Last Updated
June 7, 2022
Record last verified: 2022-06