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

• ClinicalTrials.gov Identifier: NCT04053452
• Recruitment Status: Enrolling by invitation
• First Posted: August 12, 2019
• Last Update Posted: January 25, 2022
• Sponsor: Duke University
• Collaborator: GBS-CIDP foundation
• Information provided by (Responsible Party): Duke University

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.

Condition or disease	Intervention/treatment	Phase
Guillain-Barre Syndrome	Diagnostic Test: Peripheral nerve ultrasound; Diagnostic Test: Measurement of strength	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: The EMG lab physician or technician performing the ultrasound will be blinded to the EMG/NCS results.
• Primary Purpose: Diagnostic
• Official Title: Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome: A Pilot Study
• Actual Study Start Date: September 30, 2019
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: December 30, 2022

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Internerve variability of cross-sectional area (CSA) in patients with GBS vs controls at Day 0 [ Time Frame: Within 30 days after symptom onset ]
   ROC curve of internerve CSA variability between patients with GBS and controls using ulnar and median nerves
2. Internerve CSA variability in the diagnosis of patients with GBS vs controls at Day 7 [ Time Frame: Approximately 7 days after admission ]
   ROC curve of internerve CSA variability between patients with GBS and controls using ulnar and median nerves
3. Ulnar nerve CSA variability in patients with GBS vs controls at Day 0 [ Time Frame: Within 30 days after symptom onset ]
   ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves
4. Ulnar nerve CSA variability in patients with GBS vs controls at Day 7 [ Time Frame: Approximately 7 days after admission ]
   ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves
5. Median nerve CSA variability in patients with GBS vs controls at Day 0 [ Time Frame: Within 30 days after symptom onset ]
   ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves
6. Median nerve CSA variability in patients with GBS vs controls at Day 7 [ Time Frame: Approximately 7 days after admission ]
   ROC curve of intranerve CSA variability between patients with GBS and controls using ulnar nerves

Secondary Outcome Measures :

1. Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at Day 0 [ Time Frame: 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).
2. Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at Day 7. [ Time Frame: 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).
3. Value of peripheral nerve ultrasound in prediction of length of hospital stay in patients with GBS at Day 0 [ Time Frame: 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).
4. Value of peripheral nerve ultrasound in prediction of length of hospital stay in patients with GBS at Day 7. [ Time Frame: 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).
5. Value of peripheral nerve ultrasound when measured on Day 0 in prediction of ambulatory status on discharge in patients with GBS [ Time Frame: 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).
6. Value of peripheral nerve ultrasound when measured on Day 7 in prediction of ambulatory status on discharge in patients with GBS [ Time Frame: 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).
7. Value of peripheral nerve ultrasound when measured at Day 0 in prediction of severity of respiratory dysfunction in patients with GBS. [ Time Frame: 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).
8. Value of peripheral nerve ultrasound when measured at Day 7 in prediction of severity of respiratory dysfunction in patients with GBS. [ Time Frame: 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).
9. Value of peripheral nerve ultrasound when measured at Day 0 in prediction of severity of weakness in patients with GBS. [ Time Frame: Within 30 days after symptom onset ]
   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).
10. Value of peripheral nerve ultrasound when measured at Day 0 in prediction of severity of weakness in patients with GBS. [ Time Frame: 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).
11. Value of peripheral nerve ultrasound when measured at Day 7 in prediction of severity of weakness in patients with GBS. [ Time Frame: Approximately 7 days after admission ]
    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).
12. Value of peripheral nerve ultrasound when measured at Day 7 in prediction of severity of weakness in patients with GBS. [ Time Frame: 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).
13. Value of peripheral nerve ultrasound when measured at Day 0 in prediction of autonomic dysfunction in patients with GBS. [ Time Frame: 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).
14. Value of peripheral nerve ultrasound when measured at Day 7 in prediction of autonomic dysfunction in patients with GBS. [ Time Frame: 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).
15. Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at discharge. [ Time Frame: 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).
16. Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at 3 months. [ Time Frame: 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).
17. Value of peripheral nerve ultrasound in prediction of disability in patients with GBS at 6 months. [ Time Frame: 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).

Eligibility Criteria

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

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)

Contacts and Locations

Locations

United States, North Carolina

Duke University Hospital

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

GBS-CIDP foundation

Investigators

• Principal Investigator: Lisa Hobson-Webb, M.D.; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04053452
• Other Study ID Numbers: Pro00102385
• First Posted: August 12, 2019
• Last Update Posted: January 25, 2022
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Guillain-Barre Syndrome; Syndrome; Disease; Pathologic Processes; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Polyneuropathies; Autoimmune Diseases; Immune System Diseases