Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome
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ClinicalTrials.gov Identifier: NCT04053452 |
Recruitment Status :
Enrolling by invitation
First Posted : August 12, 2019
Last Update Posted : January 25, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Guillain-Barre Syndrome | Diagnostic Test: Peripheral nerve ultrasound Diagnostic Test: Measurement of strength | Not Applicable |
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 |

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. |
- 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
- 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
- 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
- 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
- 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
- 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
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).

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

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
United States, North Carolina | |
Duke University Hospital | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Lisa Hobson-Webb, M.D. | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT04053452 |
Other Study ID Numbers: |
Pro00102385 |
First Posted: | August 12, 2019 Key Record Dates |
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 |
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 |