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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Guillain-Barre Syndrome
• Intervention / Treatment: Diagnostic test: Peripheral nerve ultrasound; Diagnostic test: Measurement of strength

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Controls	Diagnostic test: Peripheral nerve ultrasound; Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
Experimental: GBS Patients	Diagnostic test: Peripheral nerve ultrasound; Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.; Diagnostic test: Measurement of strength; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: GBS-CIDP foundation
• Investigators: Principal Investigator: Lisa Hobson-Webb, M.D., Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyradiculoneuropathy; Polyneuropathies; Chronic Disease; Post-Infectious Disorders; Syndrome; Guillain-Barre Syndrome
• Other Study ID Numbers: Pro00102385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No