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

NCT04053452 | Terminated Results FDA Device

• 1 other identifier: Pro00102385
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Guillain-Barre Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Length of Hospital Stay in Days

  Up to approximately 20 days

• Ambulatory Status on Discharge

  At discharge, up to approximately 20 days

• Respiratory Dysfunction, as Measured by Number of Days Intubated

  During admission, up to approximately 20 days

• Strength, as Measured by Hand Dynamometer

  Day 0, Day 7

• Strength, as Measured by Medical Research Council (MRC)

  Day 0, Day 7

Study Arms (2)

GBS Patients

EXPERIMENTAL

Diagnostic Test: Peripheral nerve ultrasound; Diagnostic Test: Measurement of strength

Controls

ACTIVE COMPARATOR

Diagnostic Test: Peripheral nerve ultrasound

Interventions

Peripheral nerve ultrasound DIAGNOSTIC_TEST

Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.

Controls; GBS Patients

Measurement of strength DIAGNOSTIC_TEST

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.

GBS Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Duke University: lead
• GBS-CIDP foundation: collaborator

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Natalia Gonzalez, MD
• Organization: Duke University

natalia.gonzalez@duke.edu

919-684-5422

Study Officials

• Lisa Hobson-Webb, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The EMG lab physician or technician performing the ultrasound will be blinded to the EMG/NCS results.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 12, 2019
• Study Start: September 30, 2019
• Primary Completion: July 4, 2023
• Study Completion: February 5, 2024
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)