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.

NCT06615622 | Recruiting DMC

• 1 other identifier: 04-2024-200877
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Peripheral nerve ultrasound; immune mediated nerve disorders; Guillain-Barré syndrome; Chronic inflammatory demyelinating polyradiculoneuropathy

Outcome Measures

Primary Outcomes (1)

• Detection of Nerve Alterations via Ultrasound

  * Determine if patients with acute GBS and CIDP exhibit nerve alterations detectable by ultrasound that are comparable to electrodiagnostic findings. * Assess the utility of ultrasound in diagnosing GBS and CIDP in the very early phase of the disease.

  6 months

Secondary Outcomes (5)

• Evaluation of Nerve Morphology Evolution

  6 months

• Prediction of Outcomes and Recovery

  6 months

• Differentiation of Subtypes

  6 months

• Correlation with Clinical Scales

  6 months

• Comparison with Healthy Controls

  6 months

Study Arms (2)

Case

Patients with immune mediated peripheral nerve disorders GB syndrome and CIDP

Dietary Supplement: Placebo

Control

Healthy control matching group

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Thiotacid 300 mg tab once/day

Case; Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A hospital-based study. Patients who are admitted to Assiut university hospitals, neuropsychiatry department.

You may qualify if:

• 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).
• Age: Participants aged 18 to 75 years.
• 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.
• Gender: Both male and female participants are eligible.
• Participation: Willingness to participate in the study, including undergoing disease-related examinations and assessments.
• Consent: Ability and willingness to provide informed consent

You may not qualify if:

• Patients unable or unwilling to provide informed consent.
• Patients with metabolic disorders or malignancies.
• Patients with other causes of peripheral neuropathy.
• Patients with other causes of acute flaccid paralysis.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, Egypt

RECRUITING

Related Publications (8)

• 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.

  PMID: 17337484 BACKGROUND

• 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.

  PMID: 14973982 BACKGROUND

• 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.

  PMID: 25238327 BACKGROUND

• 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: 25023340 BACKGROUND

• 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: 26948435 BACKGROUND

• 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.

  PMID: 9781538 BACKGROUND

• 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.

  PMID: 35256276 BACKGROUND

• 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.

  PMID: 21422765 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples CSF samples

MeSH Terms

Conditions

Guillain-Barre Syndrome; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Neuritis; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mohammed Gad Ibrahim, MB, BCh

CONTACT

+201022748859; modyurd222@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 26, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-10

Locations

EG (1)