ClinicalTrials.gg
RecruitingNCT06615622Updated Oct 3, 2025

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.

An observational study in Guillain Barré Syndrome, Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Peripheral Nerve Disorder, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • 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
03

In context

Guillain-Barre Syndrome

96 studies on the registry are indexed under Guillain-Barre Syndrome; 28 are open to participants now.

This study's planned enrollment of 90 is close to the median of 100 across 47 observational studies indexed under Guillain-Barre Syndrome.

Browse Guillain-Barre Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  1. Patients unable or unwilling to provide .
  2. Patients with metabolic disorders or .
  3. Patients with other causes of peripheral neuropathy.
  4. Patients with other causes of acute flaccid paralysis.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Case

    Patients with immune mediated peripheral nerve disorders GB syndrome and CIDP

    Dietary Supplement: Placebo

  • Control

    Healthy control matching group

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementPlacebo

    Thiotacid 300 mg tab once/day

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What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. Evaluation of Nerve Morphology Evolution

    * Investigate patterns of nerve morphology through nerve ultrasound studies in GBS and CIDP patients over the course of the disease. * Compare these patterns with serial NCS findings.

    Time frame: 6 months

  2. Prediction of Outcomes and Recovery

    \- Evaluate the potential of nerve ultrasound changes as predictors of clinical outcomes and recovery in GBS and CIDP patients.

    Time frame: 6 months

  3. Differentiation of Subtypes

    \- Assess if early nerve ultrasound changes can differentiate between axonal and demyelinating subtypes of GBS and CIDP.

    Time frame: 6 months

  4. Correlation with Clinical Scales

    \- Correlate ultrasound findings with clinical scales and outcomes, such as the Guillain-Barré Syndrome Disability Scale (GDS), Medical Research Council Sum Score (MRC sum score), and Erasmus GBS Outcome Scale (EGOS)

    Time frame: 6 months

  5. Comparison with Healthy Controls

    \- Compare the ultrasound parameters of GBS and CIDP patients with age and sex-matched healthy controls to identify significant differences in nerve morphology

    Time frame: 6 months

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 17337484 ↗
  • 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. PubMed 14973982 ↗
  • 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. PubMed 25238327 ↗
  • 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. PubMed 25023340 ↗
  • 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. PubMed 26948435 ↗
  • 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. PubMed 9781538 ↗
  • 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. PubMed 35256276 ↗
  • 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. PubMed 21422765 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Mar 2027, 30 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2024
First posted
Sep 26, 2024
StartActual
Sep 1, 2024
Primary completionEst.
Mar 30, 2027
CompletionEst.
Mar 30, 2028
Last update
Oct 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06615622
Lead sponsor
Assiut University
Responsible party
Mohammed Gad Ibrahim Farghly (Principal Investigator, Assiut University) — Principal investigator
First posted
Sep 26, 2024
Start date
Sep 1, 2024
Primary completion
Mar 30, 2027 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Oct 3, 2025

Study contacts

Mohammed Gad Ibrahim, MB, BCh
Contact
modyurd222@gmail.com
+201022748859 ext. 1022748859

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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