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

Primary Purpose

Guillain-Barre Syndrome

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peripheral nerve ultrasound
Measurement of strength
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Guillain-Barre Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Duke University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GBS Patients

Controls

Arm Description

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).

Full Information

First Posted
August 8, 2019
Last Updated
October 10, 2023
Sponsor
Duke University
Collaborators
GBS-CIDP foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04053452
Brief Title
Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome
Official Title
Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
GBS-CIDP foundation

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guillain-Barre Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The EMG lab physician or technician performing the ultrasound will be blinded to the EMG/NCS results.
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GBS Patients
Arm Type
Experimental
Arm Title
Controls
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Peripheral nerve ultrasound
Intervention Description
Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
Intervention Type
Diagnostic Test
Intervention Name(s)
Measurement of strength
Intervention Description
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.
Primary Outcome Measure Information:
Title
Internerve variability of cross-sectional area (CSA) in patients with GBS vs controls at Day 0
Description
ROC curve of internerve CSA variability between patients with GBS and controls using ulnar and median nerves
Time Frame
Within 30 days after symptom onset
Title
Internerve CSA variability in the diagnosis of patients with GBS vs controls at Day 7
Description
ROC curve of internerve CSA variability between patients with GBS and controls using ulnar and median nerves
Time Frame
Approximately 7 days after admission
Title
Ulnar nerve CSA variability in patients with GBS vs controls at Day 0
Description
ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves
Time Frame
Within 30 days after symptom onset
Title
Ulnar nerve CSA variability in patients with GBS vs controls at Day 7
Description
ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves
Time Frame
Approximately 7 days after admission
Title
Median nerve CSA variability in patients with GBS vs controls at Day 0
Description
ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves
Time Frame
Within 30 days after symptom onset
Title
Median nerve CSA variability in patients with GBS vs controls at Day 7
Description
ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves
Time Frame
Approximately 7 days after admission
Secondary Outcome Measure Information:
Title
Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at Day 0
Description
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).
Time Frame
Within 30 days after symptom onset
Title
Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at Day 7.
Description
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).
Time Frame
Approximately 7 days after admission
Title
Value of peripheral nerve ultrasound in prediction of length of hospital stay in patients with GBS at Day 0
Description
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).
Time Frame
Within 30 days after symptom onset
Title
Value of peripheral nerve ultrasound in prediction of length of hospital stay in patients with GBS at Day 7.
Description
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).
Time Frame
Approximately 7 days after admission
Title
Value of peripheral nerve ultrasound when measured on Day 0 in prediction of ambulatory status on discharge in patients with GBS
Description
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).
Time Frame
Within 30 days after symptom onset
Title
Value of peripheral nerve ultrasound when measured on Day 7 in prediction of ambulatory status on discharge in patients with GBS
Description
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).
Time Frame
Approximately 7 days after admission
Title
Value of peripheral nerve ultrasound when measured at Day 0 in prediction of severity of respiratory dysfunction in patients with GBS.
Description
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).
Time Frame
Within 30 days after symptom onset
Title
Value of peripheral nerve ultrasound when measured at Day 7 in prediction of severity of respiratory dysfunction in patients with GBS.
Description
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).
Time Frame
Approximately 7 days after admission
Title
Value of peripheral nerve ultrasound when measured at Day 0 in prediction of severity of weakness in patients with GBS.
Description
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).
Time Frame
Within 30 days after symptom onset
Title
Value of peripheral nerve ultrasound when measured at Day 0 in prediction of severity of weakness in patients with GBS.
Description
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).
Time Frame
Within 30 days after symptom onset
Title
Value of peripheral nerve ultrasound when measured at Day 7 in prediction of severity of weakness in patients with GBS.
Description
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).
Time Frame
Approximately 7 days after admission
Title
Value of peripheral nerve ultrasound when measured at Day 7 in prediction of severity of weakness in patients with GBS.
Description
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).
Time Frame
Approximately 7 days after admission
Title
Value of peripheral nerve ultrasound when measured at Day 0 in prediction of autonomic dysfunction in patients with GBS.
Description
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).
Time Frame
Within 30 days after symptom onset
Title
Value of peripheral nerve ultrasound when measured at Day 7 in prediction of autonomic dysfunction in patients with GBS.
Description
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).
Time Frame
Approximately 7 days after admission
Title
Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at discharge.
Description
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).
Time Frame
At discharge (up to 3 months after enrollment)
Title
Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at 3 months.
Description
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).
Time Frame
Approximately 3 months after enrollment.
Title
Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at 6 months.
Description
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).
Time Frame
Approximately 6 months after enrollment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Hobson-Webb, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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