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Clinical Trials/NCT04053452
NCT04053452
Terminated
N/A

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

Duke University1 site in 1 country20 target enrollmentSeptember 30, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Guillain-Barre Syndrome
Sponsor
Duke University
Enrollment
20
Locations
1
Primary Endpoint
Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls
Status
Terminated
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2019
End Date
February 5, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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)

Outcomes

Primary Outcomes

Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Length of Hospital Stay in Days(Up to approximately 20 days)
  • Ambulatory Status on Discharge(At discharge, up to approximately 20 days)
  • Respiratory Dysfunction, as Measured by Number of Days Intubated(During admission, up to approximately 20 days)
  • Strength, as Measured by Hand Dynamometer(Day 0, Day 7)
  • Strength, as Measured by Medical Research Council (MRC)(Day 0, Day 7)
  • Number of Participants With Autonomic Dysfunction(During hospitalization, up to approximately 20 days)
  • 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)

Study Sites (1)

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