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

Guillain-Barre Syndrome Clinical Trial

Official title:

Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome: A Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04053452
• Other study ID #: Pro00102385
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: October 30, 2024

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: October 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Guillain-Barre Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Peripheral nerve ultrasound
Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
• 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.

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	GBS-CIDP foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 30 days after symptom onset
Primary	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	Approximately 7 days after admission
Primary	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	Within 30 days after symptom onset
Primary	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	Approximately 7 days after admission
Primary	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	Within 30 days after symptom onset
Primary	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	Approximately 7 days after admission
Secondary	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).	Within 30 days after symptom onset
Secondary	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).	Approximately 7 days after admission
Secondary	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).	Within 30 days after symptom onset
Secondary	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).	Approximately 7 days after admission
Secondary	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).	Within 30 days after symptom onset
Secondary	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).	Approximately 7 days after admission
Secondary	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).	Within 30 days after symptom onset
Secondary	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).	Approximately 7 days after admission
Secondary	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).	Within 30 days after symptom onset
Secondary	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).	Within 30 days after symptom onset
Secondary	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).	Approximately 7 days after admission
Secondary	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).	Approximately 7 days after admission
Secondary	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).	Within 30 days after symptom onset
Secondary	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).	Approximately 7 days after admission
Secondary	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).	At discharge (up to 3 months after enrollment)
Secondary	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).	Approximately 3 months after enrollment.
Secondary	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).	Approximately 6 months after enrollment.