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Recruiting Observational

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.

NCT06615622 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2024-09-01
Last updated
2025-10-03

Condition(s) studied

Guillain Barré SyndromeChronic Inflammatory Demyelinating PolyradiculoneuropathyPeripheral Nerve DisorderPeripheral Nerves USPeripheral Neuropathy

Investigational drug(s) / intervention(s)

Placebo

Placebo: Thiotacid 300 mg tab once/day

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Detection of Nerve Alterations via Ultrasound — 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.

Trial sites (1)

FacilityCityRegionStatus
Assiut University Hospitals Asyut Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06615622 on ClinicalTrials.gov ↗ ← All trials in Egypt