---
title: Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome
nct_id: NCT04053452
overall_status: TERMINATED
phase: NA
sponsor: Duke University
study_type: INTERVENTIONAL
primary_condition: Guillain-Barre Syndrome
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04053452.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04053452"
ct_last_update_post_date: 2025-05-09
last_seen_at: "2026-05-12T07:29:32.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome

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

**NCT ID:** [NCT04053452](https://clinicaltrials.gov/study/NCT04053452)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Low Enrollment
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Duke University
- **Collaborators:** GBS-CIDP foundation
- **Conditions:** Guillain-Barre Syndrome
- **Start Date:** 2019-09-30
- **Completion Date:** 2024-02-05
- **CT.gov Last Update:** 2025-05-09

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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)
```

## Arms

- **GBS Patients** (EXPERIMENTAL)
- **Controls** (ACTIVE_COMPARATOR)

## Interventions

- **Peripheral nerve ultrasound** (DIAGNOSTIC_TEST) — Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
- **Measurement of strength** (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.

## 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** _(time frame: Up to approximately 20 days)_
- **Ambulatory Status on Discharge** _(time frame: 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)_
- **Strength, as Measured by Hand Dynamometer** _(time frame: Day 0, Day 7)_
- **Strength, as Measured by Medical Research Council (MRC)** _(time frame: Day 0, Day 7)_
- **Number of Participants With Autonomic Dysfunction** _(time frame: 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)_

## Locations (1)

- Duke University Hospital, Durham, North Carolina, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.duke university hospital|durham|north carolina|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04053452.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04053452*  
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