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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04053452
Recruitment Status : Suspended (Due to COVID-19 restrictions)
First Posted : August 12, 2019
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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

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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, 2021
Estimated Study Completion Date : September 30, 2021


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.




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).



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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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053452


Locations
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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Lisa Hobson-Webb, M.D. Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04053452    
Other Study ID Numbers: Pro00102385
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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