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

Not Applicable

Terminated

• Conditions: Guillain-Barre Syndrome
• Interventions: Diagnostic Test: Peripheral nerve ultrasound; Diagnostic Test: Measurement of strength

• Registration Number: NCT04053452
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-12
• Study Start: 2019-09-30
• Primary Completion: 2023-07-04
• Disposition First Posted: 2023-10-11
• Study Completion: 2024-02-05
• Status Verified: 2024-05
• Disposition First Submitted: 2024-05-23
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GBS Patients	Peripheral nerve ultrasound	-
GBS Patients	Measurement of strength	-
Controls	Peripheral nerve ultrasound	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Value of peripheral nerve ultrasound when measured at Day 0 in prediction of autonomic dysfunction in patients with GBS.	Within 30 days after symptom onset	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).
Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at Day 0	Within 30 days after symptom onset	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).
Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at Day 7.	Approximately 7 days after admission	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).
Value of peripheral nerve ultrasound in prediction of length of hospital stay in patients with GBS at Day 0	Within 30 days after symptom onset	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).
Value of peripheral nerve ultrasound in prediction of length of hospital stay in patients with GBS at Day 7.	Approximately 7 days after admission	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).
Value of peripheral nerve ultrasound when measured on Day 0 in prediction of ambulatory status on discharge in patients with GBS	Within 30 days after symptom onset	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).
Value of peripheral nerve ultrasound when measured at Day 0 in prediction of severity of weakness in patients with GBS.	Within 30 days after symptom onset	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).
Value of peripheral nerve ultrasound when measured at Day 7 in prediction of severity of weakness in patients with GBS.	Approximately 7 days after admission	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).
Value of peripheral nerve ultrasound when measured on Day 7 in prediction of ambulatory status on discharge in patients with GBS	Approximately 7 days after admission	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).
Value of peripheral nerve ultrasound when measured at Day 7 in prediction of severity of respiratory dysfunction in patients with GBS.	Approximately 7 days after admission	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).
Value of peripheral nerve ultrasound when measured at Day 7 in prediction of autonomic dysfunction in patients with GBS.	Approximately 7 days after admission	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).
Value of peripheral nerve ultrasound when measured at Day 0 in prediction of severity of respiratory dysfunction in patients with GBS.	Within 30 days after symptom onset	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).
Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at discharge.	At discharge (up to 3 months after enrollment)	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).
Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at 3 months.	Approximately 3 months after enrollment.	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).
Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at 6 months.	Approximately 6 months after enrollment.	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).

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States