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Recruiting NCT06615622

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.

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Clinical Trial Summary
NCT ID NCT06615622
Status Recruiting
Phase
Sponsor Assiut University
Condition Guillain Barré Syndrome
Study Type OBSERVATIONAL
Enrollment 90 participants
Start Date 2024-09-01
Primary Completion 2027-03-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 75 Years
Study Type OBSERVATIONAL
Interventions
Placebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 90 participants in total. It began in 2024-09-01 with a primary completion date of 2027-03-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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.

Contact & Investigator

Central Contact

Mohammed Gad Ibrahim, MB, BCh

✉ modyurd222@gmail.com

📞 +201022748859

Frequently Asked Questions

Who can join the NCT06615622 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Guillain Barré Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06615622 currently recruiting?

Yes, NCT06615622 is actively recruiting participants. Contact the research team at modyurd222@gmail.com for enrollment information.

Where is the NCT06615622 trial being conducted?

This trial is being conducted at Asyut, Egypt.

Who is sponsoring the NCT06615622 clinical trial?

NCT06615622 is sponsored by Assiut University. The trial plans to enroll 90 participants.

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