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.

Assiut University

Status: Enrolling

Conditions: Peripheral Neuropathy; Peripheral Nerves US; Peripheral Nerve Disorder; Guillain Barré Syndrome; Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Treatments: Dietary Supplement: Placebo

Study type: Observational

Funder types: Other

Identifiers

NCT06615622

04-2024-200877

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

90 participants in 2 patient groups

Case

Description:

Patients with immune mediated peripheral nerve disorders GB syndrome and CIDP

Treatment:

Dietary Supplement: Placebo

Control

Description:

Healthy control matching group

Treatment:

Dietary Supplement: Placebo