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: Terminated
• Conditions: Guillain-Barre Syndrome
• Intervention / Treatment: Diagnostic test: Peripheral nerve ultrasound; Diagnostic test: Measurement of strength

• Study Type: Interventional
• Enrollment (Actual): 20
• 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	Internerve CSA variability for each patient will be calculated as: maximal intranerve CSA variability/minimal intranerve CSA variability. Intranerve CSA variability for each nerve will be calculated as: maximal CSA/minimal CSA for median and ulnar nerves.	Day 0 and approximately 7 days after admission
Median Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls	Intranerve CSA variability for each nerve is calculated as: maximal intranerve CSA/minimal intranerve CSA . When both left and right ulnar nerves were scanned, the side with the largest intranerve CSA variability was used for analysis.	Day 0 and approximately 7 days after admission
Ulnar Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls	Intranerve CSA variability for each nerve is calculated as: maximal intranerve CSA/minimal intranerve CSA . When both left and right ulnar nerves were scanned, the side with the largest intranerve CSA variability was used for analysis.	Day 0 and approximately 7 days after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay in Days	Length of hospital stay is measured to the nearest day (by chart review).	Up to approximately 20 days
Ambulatory Status on Discharge	Number of participants with ambulatory status as "ambulatory with or without assistance".	At discharge, up to approximately 20 days
Respiratory Dysfunction, as Measured by Number of Days Intubated	Respiratory dysfunction will be measured by number of days intubated (to the nearest day) by chart review.	During admission, up to approximately 20 days
Strength, as Measured by Hand Dynamometer	Average of left and right hand grip strength (in pounds).	Day 0, Day 7
Strength, as Measured by Medical Research Council (MRC)	The Medical Research Council (MRC) total score ranges from 0-60, with higher values indicating greater muscle strength. The MRC total score is the sum score of the following muscle group subscales (each assessed on the left side and right side): bilateral shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion. Each muscle group subscale is rated 0-5, with 0 being no movement and 5 being full strength.	Day 0, Day 7
Number of Participants With Autonomic Dysfunction	Autonomic dysfunction will be either present or absent by chart review during hospitalization.	During hospitalization, up to approximately 20 days
Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score	The GBS disability score ranges from 0-6 with lower scores indicating a better outcome (0 is healthy, 6 is death).	Day 0, Day 7, Discharge (up to approximately 20 days), Day 90, Day 180

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 (Actual): July 4, 2023
• Study Completion (Actual): February 5, 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): May 9, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Disease; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Polyradiculoneuropathy; 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