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.

Last updated: October 1, 2025
Sponsor: Assiut University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Peripheral Neuropathy

Neuropathy

Treatment

Placebo

Clinical Study ID

NCT06615622
04-2024-200877
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of patient group:
  • GBS Patients: Diagnosed according to the criteria of the National Institute ofNeurological Disorders and Stroke (NINDS) and the Brighton Collaboration (2011).

  • CIDP Patients: Diagnosed according to the criteria of the European Federationof Neurological Societies/Peripheral Nerve Society (EFNS/PNS).

  1. Age: Participants aged 18 to 75 years.

  2. Onset:

  • GBS Patients: Recent onset of GBS within the first 2 weeks of symptom onset.

  • CIDP Patients: Either relapsing or progressive course consistent with CIDPdiagnosis.

  1. Gender: Both male and female participants are eligible.

  2. Participation: Willingness to participate in the study, including undergoingdisease-related examinations and assessments.

  3. Consent: Ability and willingness to provide informed consent

Exclusion

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 Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Placebo
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
March 30, 2028

Connect with a study center

  • Assiut University Hospitals

    Assiut,
    Egypt

    Site Not Available

  • Assiut University Hospitals

    Asyut 359783,
    Egypt

    Active - Recruiting

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