Skip to content

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.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06615622
Enrollment
90
Registered
2024-09-26
Start date
2024-09-01
Completion date
2028-03-30
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Guillain Barré Syndrome, Peripheral Nerve Disorder, Peripheral Nerves US, Peripheral Neuropathy

Keywords

Peripheral nerve ultrasound, immune mediated nerve disorders, Guillain-Barré syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

Thiotacid 300 mg tab once/day

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Detection of Nerve Alterations via Ultrasound6 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

MeasureTime frameDescription
Evaluation of Nerve Morphology Evolution6 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 Recovery6 months\- Evaluate the potential of nerve ultrasound changes as predictors of clinical outcomes and recovery in GBS and CIDP patients.
Differentiation of Subtypes6 months\- Assess if early nerve ultrasound changes can differentiate between axonal and demyelinating subtypes of GBS and CIDP.
Correlation with Clinical Scales6 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 Controls6 months\- Compare the ultrasound parameters of GBS and CIDP patients with age and sex-matched healthy controls to identify significant differences in nerve morphology

Countries

Egypt

Contacts

Primary ContactMohammed Gad Ibrahim, MB, BCh
modyurd222@gmail.com+201022748859

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026