NCT05284786

Brief Summary

Description of the time course of nerve ultrasonography changes in correlation to nerve conduction studies (NCS) and clinical course.

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
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

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

March 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

March 9, 2022

Last Update Submit

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

Age15 Years - 60 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

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: 27666816BACKGROUND
  • van 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: 25023340BACKGROUND
  • Willison 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: 26948435BACKGROUND
  • Asbury 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: 2194422BACKGROUND
  • Hadden 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: 9818934BACKGROUND
  • Uncini 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: 30419502BACKGROUND
  • Rajabally 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: 26194045BACKGROUND
  • Gallardo 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: 25653385BACKGROUND
  • Gallardo 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: 25213352BACKGROUND
  • Kerasnoudis 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: 24028191BACKGROUND
  • Kerasnoudis 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: 24070674BACKGROUND
  • Scheidl 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: 24613217BACKGROUND
  • Zaidman 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: 19697380BACKGROUND
  • Grimm 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

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

Amr Galal, specialist

CONTACT

Mohamed Mustafa, lecturer

CONTACT

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