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.

Recruiting

• Conditions: Guillain Barré Syndrome; Chronic Inflammatory Demyelinating Polyradiculoneuropathy; Peripheral Nerve Disorder; Peripheral Nerves US; Peripheral Neuropathy
• Interventions: Dietary Supplement: Placebo

• Registration Number: NCT06615622
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-01
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26
• Primary Completion: 2027-03-30
• Study Completion: 2028-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Placebo	Patients with immune mediated peripheral nerve disorders GB syndrome and CIDP
Control	Placebo	Healthy control matching group

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Nerve Morphology Evolution	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.
Prediction of Outcomes and Recovery	6 months	- Evaluate the potential of nerve ultrasound changes as predictors of clinical outcomes and recovery in GBS and CIDP patients.
Differentiation of Subtypes	6 months	- Assess if early nerve ultrasound changes can differentiate between axonal and demyelinating subtypes of GBS and CIDP.
Correlation with Clinical Scales	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)
Comparison with Healthy Controls	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

Trial Locations

Locations (1)

Assiut University Hospitals; 🇪🇬 Assiut, Egypt