Clinical trial NCT06615622: 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.
Official title: A Comparative Study of Peripheral Nerve Ultrasound Findings in Immune Mediated Peripheral Nerve Disorders; a Hospital-based Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Guillain Barré Syndrome
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Peripheral Nerve Disorder
Peripheral Nerves US
Peripheral Neuropathy
Keywords: Peripheral nerve ultrasound
immune mediated nerve disorders
Guillain-Barré syndrome
Chronic inflammatory demyelinating polyradiculoneuropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A hospital-based study. Patients who are admitted to Assiut university hospitals, neuropsychiatry department.

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\&amp;#39; 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: 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 outcomes:
measure: Detection of Nerve Alterations via Ultrasound
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of Nerve Morphology Evolution
timeFrame: 6 months
measure: Prediction of Outcomes and Recovery
timeFrame: 6 months
measure: Differentiation of Subtypes
timeFrame: 6 months
measure: Correlation with Clinical Scales
timeFrame: 6 months
measure: Comparison with Healthy Controls
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
Study officials:
References:
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