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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2028-03-30

Brief Summary

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Neuromuscular ultrasound (NMUS) is emerging as a valuable non-invasive diagnostic tool. In GBS, NMUS can detect proximal nerve enlargement early, before neurophysiological changes. Persistent nerve enlargement can be observed up to 15 years, though its correlation with disability varies. Research is needed to clarify NMUS findings in GBS and CIDP over time. Early detection of nerve root enlargement via NMUS could facilitate earlier diagnosis and intervention, improving patient outcomes and understanding of these conditions\' pathophysiology.

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.

Detailed Description

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Conditions

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Guillain Barré Syndrome Chronic Inflammatory Demyelinating Polyradiculoneuropathy Peripheral Nerve Disorder Peripheral Nerves US Peripheral Neuropathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

Patients with immune mediated peripheral nerve disorders GB syndrome and CIDP

Placebo

Intervention Type DIETARY_SUPPLEMENT

Thiotacid 300 mg tab once/day

Control

Healthy control matching group

Placebo

Intervention Type DIETARY_SUPPLEMENT

Thiotacid 300 mg tab once/day

Interventions

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Placebo

Thiotacid 300 mg tab once/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of patient group:

* 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

1. Patients unable or unwilling to provide informed consent.
2. Patients with metabolic disorders or malignancies.
3. Patients with other causes of peripheral neuropathy.
4. Patients with other causes of acute flaccid paralysis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Gad Ibrahim Farghly

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Hospitals

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammed Gad Ibrahim, MB, BCh

Role: CONTACT

+201022748859 ext. 1022748859

Facility Contacts

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Vice president of graduate studies of Assiut University

Role: primary

+2088 22080150

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.

Reference Type BACKGROUND
PMID: 17337484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14973982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25238327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25023340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26948435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9781538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35256276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21422765 (View on PubMed)

Other Identifiers

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04-2024-200877

Identifier Type: -

Identifier Source: org_study_id

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