Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine if peripheral nerve ultrasound can be used as a supplemental tool to diagnose Guillain-Barre syndrome (GBS) in the acute setting and aid in prognostication.

Official Title
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Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome: A Pilot Study

Conditions
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Guillain-Barre Syndrome

Intervention / Treatment
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* Diagnostic Test: Peripheral nerve ultrasound
* Diagnostic Test: Measurement of strength


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For GBS group: Inpatients with acute, progressive weakness and no alternative diagnosis, with onset less than 30 days prior to examination. For control group: Hospitalized patients on the inpatient neurology service who are being treated for non-peripheral nerve disorders (e.g. epilepsy, multiple sclerosis, or stroke). For all subjects: 18+ years of age Exclusion Criteria: - Patients with any history of multifocal motor neuropathy (MMN), prior Guillain-Barre syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), or hereditary neuropathy (e.g. Charcot-Marie-Tooth)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GBS Patients<br> | Diagnostic Test: Peripheral nerve ultrasound<br>* Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.<br>Diagnostic Test: Measurement of strength<br>* Strength will be assessed by physical examination and recorded using Medical Research Council (MRC) scale, and a hand dynamometer will be used to measure grip strength.<br>|
| Active Comparator: Controls<br> | Diagnostic Test: Peripheral nerve ultrasound<br>* Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internerve variability of cross-sectional area (CSA) in patients with GBS vs controls at Day 0 | ROC curve of internerve CSA variability between patients with GBS and controls using ulnar and median nerves | Within 30 days after symptom onset | 
| Internerve CSA variability in the diagnosis of patients with GBS vs controls at Day 7 | ROC curve of internerve CSA variability between patients with GBS and controls using ulnar and median nerves | Approximately 7 days after admission | 
| Ulnar nerve CSA variability in patients with GBS vs controls at Day 0 | ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves | Within 30 days after symptom onset | 
| Ulnar nerve CSA variability in patients with GBS vs controls at Day 7 | ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves | Approximately 7 days after admission | 
| Median nerve CSA variability in patients with GBS vs controls at Day 0 | ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves | Within 30 days after symptom onset | 
| Median nerve CSA variability in patients with GBS vs controls at Day 7 | ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves | Approximately 7 days after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at Day 0 | Disability is measured by the GBS Disability Score. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Within 30 days after symptom onset | 
| Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at Day 7. | Disability is measured by the GBS Disability Score. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Approximately 7 days after admission | 
| Value of peripheral nerve ultrasound in prediction of length of hospital stay in patients with GBS at Day 0 | Length of hospital stay is measured to the nearest day (by chart review). Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Within 30 days after symptom onset | 
| Value of peripheral nerve ultrasound in prediction of length of hospital stay in patients with GBS at Day 7. | Length of hospital stay is measured to the nearest day (by chart review). Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Approximately 7 days after admission | 
| Value of peripheral nerve ultrasound when measured on Day 0 in prediction of ambulatory status on discharge in patients with GBS | Ambulatory status is either (1) ambulatory with or without assistance or (2) non-ambulatory (by chart review). Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Within 30 days after symptom onset | 
| Value of peripheral nerve ultrasound when measured on Day 7 in prediction of ambulatory status on discharge in patients with GBS | Ambulatory status is either (1) ambulatory with or without assistance or (2) non-ambulatory (by chart review). Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Approximately 7 days after admission | 
| Value of peripheral nerve ultrasound when measured at Day 0 in prediction of severity of respiratory dysfunction in patients with GBS. | Respiratory dysfunction will be measured by number of days intubated (to the nearest day) by chart review. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Within 30 days after symptom onset | 
| Value of peripheral nerve ultrasound when measured at Day 7 in prediction of severity of respiratory dysfunction in patients with GBS. | Respiratory dysfunction will be measured by number of days intubated (to the nearest day) by chart review. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Approximately 7 days after admission | 
| Value of peripheral nerve ultrasound when measured at Day 0 in prediction of severity of weakness in patients with GBS. | Weakness will be measured by hand dynamometer. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Within 30 days after symptom onset | 
| Value of peripheral nerve ultrasound when measured at Day 0 in prediction of severity of weakness in patients with GBS. | Weakness will be measured by manual muscle testing using the Medical Research Council (MRC) scale. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Within 30 days after symptom onset | 
| Value of peripheral nerve ultrasound when measured at Day 7 in prediction of severity of weakness in patients with GBS. | Weakness will be measured by hand dynamometer. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Approximately 7 days after admission | 
| Value of peripheral nerve ultrasound when measured at Day 7 in prediction of severity of weakness in patients with GBS. | Weakness will be measured by manual muscle testing using the Medical Research Council (MRC) scale. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Approximately 7 days after admission | 
| Value of peripheral nerve ultrasound when measured at Day 0 in prediction of autonomic dysfunction in patients with GBS. | Autonomic dysfunction will be either present or absent by chart review. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Within 30 days after symptom onset | 
| Value of peripheral nerve ultrasound when measured at Day 7 in prediction of autonomic dysfunction in patients with GBS. | Autonomic dysfunction will be either present or absent by chart review. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Approximately 7 days after admission | 
| Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at discharge. | Disability is measured by the GBS Disability Score. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | At discharge (up to 3 months after enrollment) | 
| Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at 3 months. | Disability is measured by the GBS Disability Score. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Approximately 3 months after enrollment. | 
| Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at 6 months. | Disability is measured by the GBS Disability Score. Peripheral nerve ultrasound measures are internerve and intranerve CSA and mean CSA of median nerve, ulnar nerve, vagus nerve, C6 nerve root, and C7 nerve root). | Approximately 6 months after enrollment. |