Our Study Aims to Determine if Nerve Alterations in Acute GBS and CIDP Detectable by Ultrasound Match Electrodiagnostic Findings and if This Method Aids Early Diagnosis, Predict Their Outcomes and Differentiate Between Axonal and Demyelinating Subtypes.
NCT ID: NCT06615622
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2024-09-01
2028-03-30
Brief Summary
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This study aims to determine if nerve alterations in acute GBS and CIDP detectable by ultrasound match electrodiagnostic findings and if this method aids early diagnosis. The investigators will perform serial nerve ultrasounds and NCS to investigate nerve morphology, predict outcomes, and differentiate between axonal and demyelinating subtypes.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case
Patients with immune mediated peripheral nerve disorders GB syndrome and CIDP
Placebo
Thiotacid 300 mg tab once/day
Control
Healthy control matching group
Placebo
Thiotacid 300 mg tab once/day
Interventions
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Placebo
Thiotacid 300 mg tab once/day
Eligibility Criteria
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Inclusion Criteria
* GBS Patients: Diagnosed according to the criteria of the National Institute of Neurological Disorders and Stroke (NINDS) and the Brighton Collaboration (2011).
* CIDP Patients: Diagnosed according to the criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS).
2. Age: Participants aged 18 to 75 years.
3. Onset:
* GBS Patients: Recent onset of GBS within the first 2 weeks of symptom onset.
* CIDP Patients: Either relapsing or progressive course consistent with CIDP diagnosis.
4. Gender: Both male and female participants are eligible.
5. Participation: Willingness to participate in the study, including undergoing disease-related examinations and assessments.
6. Consent: Ability and willingness to provide informed consent
Exclusion Criteria
2. Patients with metabolic disorders or malignancies.
3. Patients with other causes of peripheral neuropathy.
4. Patients with other causes of acute flaccid paralysis.
18 Years
75 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Mohammed Gad Ibrahim Farghly
Principal Investigator
Locations
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Assiut University Hospitals
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Vice president of graduate studies of Assiut University
Role: primary
References
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Hughes RA, Swan AV, Raphael JC, Annane D, van Koningsveld R, van Doorn PA. Immunotherapy for Guillain-Barre syndrome: a systematic review. Brain. 2007 Sep;130(Pt 9):2245-57. doi: 10.1093/brain/awm004. Epub 2007 Mar 2.
Hughes RA, Raphael JC, Swan AV, Doorn PA. Intravenous immunoglobulin for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2004;(1):CD002063. doi: 10.1002/14651858.CD002063.pub2.
Hughes RA, Swan AV, van Doorn PA. Intravenous immunoglobulin for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2014 Sep 19;2014(9):CD002063. doi: 10.1002/14651858.CD002063.pub6.
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.
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.
Jacobs BC, Rothbarth PH, van der Meche FG, Herbrink P, Schmitz PI, de Klerk MA, van Doorn PA. The spectrum of antecedent infections in Guillain-Barre syndrome: a case-control study. Neurology. 1998 Oct;51(4):1110-5. doi: 10.1212/wnl.51.4.1110.
Laman JD, Huizinga R, Boons GJ, Jacobs BC. Guillain-Barre syndrome: expanding the concept of molecular mimicry. Trends Immunol. 2022 Apr;43(4):296-308. doi: 10.1016/j.it.2022.02.003. Epub 2022 Mar 4.
Sejvar JJ, Baughman AL, Wise M, Morgan OW. Population incidence of Guillain-Barre syndrome: a systematic review and meta-analysis. Neuroepidemiology. 2011;36(2):123-33. doi: 10.1159/000324710. Epub 2011 Mar 21.
Other Identifiers
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04-2024-200877
Identifier Type: -
Identifier Source: org_study_id
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