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

April 24, 2025 updated by: Duke University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 0 and approximately 7 days after admission
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.
Day 0 and approximately 7 days after admission
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.
Day 0 and approximately 7 days after admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay in Days
Time Frame: Up to approximately 20 days
Length of hospital stay is measured to the nearest day (by chart review).
Up to approximately 20 days
Ambulatory Status on Discharge
Time Frame: At discharge, up to approximately 20 days
Number of participants with ambulatory status as "ambulatory with or without assistance".
At discharge, up to approximately 20 days
Respiratory Dysfunction, as Measured by Number of Days Intubated
Time Frame: During admission, up to approximately 20 days
Respiratory dysfunction will be measured by number of days intubated (to the nearest day) by chart review.
During admission, up to approximately 20 days
Strength, as Measured by Hand Dynamometer
Time Frame: Day 0, Day 7
Average of left and right hand grip strength (in pounds).
Day 0, Day 7
Strength, as Measured by Medical Research Council (MRC)
Time Frame: 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.
Day 0, Day 7
Number of Participants With Autonomic Dysfunction
Time Frame: During hospitalization, up to approximately 20 days
Autonomic dysfunction will be either present or absent by chart review during hospitalization.
During hospitalization, up to approximately 20 days
Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score
Time Frame: 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).
Day 0, Day 7, Discharge (up to approximately 20 days), Day 90, Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GBS-CIDP foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Hobson-Webb, M.D., Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00102385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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