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

Not Applicable

Terminated

• Conditions: Guillain-Barre Syndrome
• Interventions: Diagnostic Test: Peripheral nerve ultrasound; Diagnostic Test: Measurement of strength

• Registration Number: NCT04053452
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-12
• Study Start: 2019-09-30
• Primary Completion: 2023-07-04
• Study Completion: 2024-02-05
• Disposition First Submitted: 2024-05-23
• Status Verified: 2025-03
• Results First Submitted: 2025-03-18
• Results First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Results First Posted: 2025-05-09
• Disposition First Posted: 2025-05-09
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GBS Patients	Peripheral nerve ultrasound	-
GBS Patients	Measurement of strength	-
Controls	Peripheral nerve ultrasound	-

Primary Outcome Measures

Name	Time	Method
Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls	Day 0 and approximately 7 days after admission	Internerve CSA variability for each patient will be calculated as: maximal intranerve CSA variability/minimal intranerve CSA variability. Intranerve CSA variability for each nerve will be calculated as: maximal CSA/minimal CSA for median and ulnar nerves.
Median Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls	Day 0 and approximately 7 days after admission	Intranerve CSA variability for each nerve is calculated as: maximal intranerve CSA/minimal intranerve CSA . When both left and right ulnar nerves were scanned, the side with the largest intranerve CSA variability was used for analysis.
Ulnar Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls	Day 0 and approximately 7 days after admission	Intranerve CSA variability for each nerve is calculated as: maximal intranerve CSA/minimal intranerve CSA . When both left and right ulnar nerves were scanned, the side with the largest intranerve CSA variability was used for analysis.

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay in Days	Up to approximately 20 days	Length of hospital stay is measured to the nearest day (by chart review).
Ambulatory Status on Discharge	At discharge, up to approximately 20 days	Number of participants with ambulatory status as "ambulatory with or without assistance".
Respiratory Dysfunction, as Measured by Number of Days Intubated	During admission, up to approximately 20 days	Respiratory dysfunction will be measured by number of days intubated (to the nearest day) by chart review.
Strength, as Measured by Hand Dynamometer	Day 0, Day 7	Average of left and right hand grip strength (in pounds).
Strength, as Measured by Medical Research Council (MRC)	Day 0, Day 7	The Medical Research Council (MRC) total score ranges from 0-60, with higher values indicating greater muscle strength. The MRC total score is the sum score of the following muscle group subscales (each assessed on the left side and right side): bilateral shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion. Each muscle group subscale is rated 0-5, with 0 being no movement and 5 being full strength.
Number of Participants With Autonomic Dysfunction	During hospitalization, up to approximately 20 days	Autonomic dysfunction will be either present or absent by chart review during hospitalization.
Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score	Day 0, Day 7, Discharge (up to approximately 20 days), Day 90, Day 180	The GBS disability score ranges from 0-6 with lower scores indicating a better outcome (0 is healthy, 6 is death).

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States