Guillain-Barre SyndromeNCT04053452
Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome
A study testing Peripheral nerve ultrasound and Measurement of strength in people with Guillain-Barre Syndrome, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guillain-Barre Syndrome
- What is being tested?
- Peripheral nerve ultrasound and Measurement of strength
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: 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.
- Conditions
- Guillain-Barre Syndrome
- Being tested
- Peripheral nerve ultrasound, Measurement of strength
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral nerve ultrasoundDiagnostic test
Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
Measurement of strengthDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| GBS Patients | Experimental | Not described Receives: Diagnostic Test: Peripheral nerve ultrasound; Diagnostic Test: Measurement of strength |
| Controls | Active comparator | Not described Receives: Diagnostic Test: Peripheral nerve ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls
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.
Measured: Day 0 and approximately 7 days after admission
Median Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls
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.
Measured: Day 0 and approximately 7 days after admission
Ulnar Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls
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.
Measured: Day 0 and approximately 7 days after admission
Secondary outcomes (7)
Length of Hospital Stay in Days
Length of hospital stay is measured to the nearest day (by chart review).
Measured: Up to approximately 20 days
Ambulatory Status on Discharge
Number of participants with ambulatory status as "ambulatory with or without assistance".
Measured: At discharge, up to approximately 20 days
Respiratory Dysfunction, as Measured by Number of Days Intubated
Respiratory dysfunction will be measured by number of days intubated (to the nearest day) by chart review.
Measured: During admission, up to approximately 20 days
Strength, as Measured by Hand Dynamometer
Average of left and right hand grip strength (in pounds).
Measured: Day 0, Day 7
Strength, as Measured by Medical Research Council (MRC)
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.
Measured: Day 0, Day 7
Number of Participants With Autonomic Dysfunction
Autonomic dysfunction will be either present or absent by chart review during hospitalization.
Measured: During hospitalization, up to approximately 20 days
Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score
The GBS disability score ranges from 0-6 with lower scores indicating a better outcome (0 is healthy, 6 is death).
Measured: Day 0, Day 7, Discharge (up to approximately 20 days), Day 90, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start30 Sep 2019
- Primary completion4 Jul 2023
- Study completion5 Feb 2024
Why it stopped: Low Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Guillain-Barre SyndromeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- GBS-CIDP foundation
- Responsible party
- Sponsor
- Investigators
- Lisa Hobson-Webb, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053452
- Sponsor's protocol ID
- Pro00102385
- Status last verified
- Mar 2025
- First submitted
- 8 Aug 2019
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT04053452
- Acronym / sponsor ID
- Pro00102385
- Conditions
- Guillain-Barre Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Enrollment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- GBS-CIDP foundation
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBS Patients | Experimental | Diagnostic Test: Peripheral nerve ultrasound, Diagnostic Test: Measurement of strength |
| Controls | Active comparator | Diagnostic Test: Peripheral nerve ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral nerve ultrasoundUltrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed. | Diagnostic test | Controls, GBS Patients |
| Measurement of strengthStrength 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. | Diagnostic test | GBS Patients |
Primary outcome
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.
7 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Hobson-Webb, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral nerve ultrasound and Measurement of strength in people with Guillain-Barre Syndrome, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls (time frame: Day 0 and approximately 7 days after admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.