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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.

ConditionsGuillain Barré SyndromeChronic Inflammatory Demyelinating PolyradiculoneuropathyPeripheral Nerve DisorderPeripheral Nerves USPeripheral Neuropathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorAssiut University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

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

Disqualifiers

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.

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Placebo

    Dietary supplement

    Thiotacid 300 mg tab once/day

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Case1 intervention
Group B: Control1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov
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