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NCT Number: NCT06615622

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.

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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Key information

Conditions

Guillain Barré Syndrome Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Chronic Inflammatory Demyelinating Polyradiculoneuropathy Demyelinating Diseases Disease Attributes Guillain-Barre Syndrome Immune System Diseases Nervous System Diseases Neuritis Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nerve Disorder Peripheral Nerves US Peripheral Nervous System Diseases Peripheral Neuropathy Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Post-Infectious Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University Hospitals

Asyut, Egypt

Location status: Recruiting

Location contact

Vice president of graduate studies of Assiut University

CONTACT

[email protected]

+2088 22080150

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Placebo

Dietary Supplement

Thiotacid 300 mg tab once/day

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Differentiation of Subtypes

    Time frame: 6 months

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

  4. 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)

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Gad Ibrahim, MB, BCh

CONTACT

[email protected]

+201022748859 ext. 1022748859

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 26, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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