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.

October 1, 2025 updated by: Mohammed Gad Ibrahim Farghly, Assiut University

A Comparative Study of Peripheral Nerve Ultrasound Findings in Immune Mediated Peripheral Nerve Disorders; a Hospital-based Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohammed Gad Ibrahim, MB, BCh
  • Phone Number: 1022748859 +201022748859
  • Email: modyurd222@gmail.com

Study Locations

  • Egypt
      • Asyut, Egypt
        • Recruiting
        • Assiut university hospitals
        • Contact:
          • Vice president of graduate studies of Assiut University
          • Phone Number: +2088 22080150
          • Email: vp_grad@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case
Patients with immune mediated peripheral nerve disorders GB syndrome and CIDP
Dietary supplement: Placebo
Thiotacid 300 mg tab once/day
Control
Healthy control matching group
Dietary supplement: Placebo
Thiotacid 300 mg tab once/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Nerve Alterations via Ultrasound
Time Frame: 6 months
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Nerve Morphology Evolution
Time Frame: 6 months
  • 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.
6 months
Prediction of Outcomes and Recovery
Time Frame: 6 months
- Evaluate the potential of nerve ultrasound changes as predictors of clinical outcomes and recovery in GBS and CIDP patients.
6 months
Differentiation of Subtypes
Time Frame: 6 months
- Assess if early nerve ultrasound changes can differentiate between axonal and demyelinating subtypes of GBS and CIDP.
6 months
Correlation with Clinical Scales
Time Frame: 6 months
- 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)
6 months
Comparison with Healthy Controls
Time Frame: 6 months
- Compare the ultrasound parameters of GBS and CIDP patients with age and sex-matched healthy controls to identify significant differences in nerve morphology
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2028

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2024-200877

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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