An observational study in Guillain-Barre Syndrome, sponsored by Assiut University. Status unknown. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-06-07.
Sponsored by Assiut University · Observational
Description of the time course of nerve ultrasonography changes in correlation to nerve conduction studies (NCS) and clinical course.
GBS is an acute- or subacute-onset polyradiculoneuropathy that often follows an upper or lower respiratory illness or gastroenteritis by 10 to 14 days. Approximately 70% of patients can identify a preceding illness, although it is often benign and may be minimized or forgotten by the patient.
GBS evolves over days, often beginning with numbness in the lower limbs and weakness in the same distribution. The progression of symptoms, particularly weakness, can be rapid, resulting in quadriplegia within a few days. About 50% of patients develop some degree of facial weakness. Weakness attributed to other cranial nerves includes ocular dysmotility, pupillary changes, and ptosis. Thirty percent of patients with GBS develop respiratory failure from phrenic nerve disease, requiring intubation and ventilation. Autonomic involvement is common in GBS, with the most common manifestations being tachycardia, bradycardia, hypertension and hypotension, gastric hypomotility, and urinary retention.
Evidence-based research supports the use of immunotherapy for GBS; proven therapies are IV immunoglobulin (IVIg) and plasma exchange, which have been shown to be equally efficacious in the management of GBS.
At present, no biomarkers exist in the blood, urine, or CSF that confirm the diagnosis of GBS. Most patients with GBS will have an elevated CSF protein, but this laboratory finding may not be present until 3 weeks after the onset of the illness. Nerve conduction studies (NCS) play an important role in support GBS diagnosis and subtype classification. In the first few days of the illness, nerve conduction studies may be normal or only show subtle changes of demyelination, such as prolonged or absent F waves and H reflexes, and patchy changes in distal latencies in patients with AIDP.
More recently, there has been a rise in the use of peripheral nerve ultrasound (US) in the investigation of peripheral neuropathies. Whilst nerve conduction studies (NCS) are helpful at providing information on the function of nerves, US is able to provide information on nerve morphology. The value of nerve ultrasonography (NUS) in immune-mediated polyneuropathies is well described in the previous studies. In post-GBS patients patchy and slight enlargements have been reported. Whereas in acute stage cervical spinal nerve enlargement and hypertrophy of the vagus are probably the most obvious findings. However, only little is known about the course of nerve morphology from onset until clinical recovery.
84 studies on the registry are indexed under Guillain-Barre Syndrome; 28 are open to participants now.
This study's planned enrollment of 45 is below the median of 100 across 40 observational studies indexed under Guillain-Barre Syndrome.
Browse Guillain-Barre Syndrome studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
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Each patient will be submitted to:
Clinical assessment scales, ultrasonography assessment of peripheral nerves together with nerve conduction study will performed in all patient within first two weeks of symptoms onset, after two weeks of IVIG or plasmapheresis treatment and after 3 months as follow up.
Clinical assessment scales of different variants GBS:
Exclusion Criteria:
Ultrasonography of different nerves was performed using a high frequency 18 MHz probe (esaote Ultrasound systems). Each nerve was scanned in axial plane, and the cross-sectional area (CSA) was measured at standardized anatomical points, in brief: median nerve in upper arm, elbow, forearm; ulnar nerve in upper arm and forearm; tibial nerve in popliteal and ankle; peroneal nerve in popliteal fossa, sural nerve in the calf and the vagus nerve.
significance of ultrasonography nerve assessement in follow up of course of the disease
Uses of ultrasonography as an investigatory tool for assessment of changes occur in the nerves over course of disease. Changes in nerves detected by ultrasonography might be an early marker in GBS and support diagnosis of disease in early phase. Also, there are some characteristic differences in ultra-sonographic nerve changes between GBS and CIDP and as known about 15-20% of cases of CIDP are presented with acute onset similar to GBS making an ultrasound can be used as prognostic tool in identification of cases with acute onset CIDP that presented with similar picture of GBS
Time frame: Baseline
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This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Assiut University