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

NCT ID: NCT04053452

Last Updated: 2025-05-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2024-02-05

Brief Summary

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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

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Conditions

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Guillain-Barre Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators
The EMG lab physician or technician performing the ultrasound will be blinded to the EMG/NCS results.

Study Groups

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GBS Patients

Group Type EXPERIMENTAL

Peripheral nerve ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.

Measurement of strength

Intervention Type DIAGNOSTIC_TEST

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.

Controls

Group Type ACTIVE_COMPARATOR

Peripheral nerve ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.

Interventions

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Peripheral nerve ultrasound

Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GBS-CIDP foundation

UNKNOWN

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Hobson-Webb, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Hospital

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Pro00102385

Identifier Type: -

Identifier Source: org_study_id

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