Trial Outcomes & Findings for Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome (NCT NCT04053452)
NCT ID: NCT04053452
Last Updated: 2025-05-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Day 0 and approximately 7 days after admission
Results posted on
2025-05-09
Participant Flow
Participant milestones
| Measure |
GBS Patients
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
|
Overall Study
COMPLETED
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
GBS Patients
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Time restraint due to inpatient needs
|
1
|
2
|
Baseline Characteristics
Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome
Baseline characteristics by cohort
| Measure |
GBS Patients
n=14 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
n=6 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.71 years
STANDARD_DEVIATION 13.93 • n=5 Participants
|
59.30 years
STANDARD_DEVIATION 15.19 • n=7 Participants
|
58.23 years
STANDARD_DEVIATION 14.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 and approximately 7 days after admissionPopulation: Participants with data collected at each time point.
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.
Outcome measures
| Measure |
GBS Patients
n=14 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
n=6 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls
Day 0
|
1.82 mm^2
Standard Deviation 0.43
|
1.49 mm^2
Standard Deviation 0.31
|
|
Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls
Day 7
|
1.38 mm^2
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: Day 0 and approximately 7 days after admissionPopulation: Participants with data collected at each time point.
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.
Outcome measures
| Measure |
GBS Patients
n=14 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
n=6 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Median Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls
Day 0
|
1.96 mm^2
Standard Deviation 0.51
|
1.73 mm^2
Standard Deviation 0.56
|
|
Median Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls
Day 7
|
1.63 mm^2
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: Day 0 and approximately 7 days after admissionPopulation: Participants with data collected at each time point.
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.
Outcome measures
| Measure |
GBS Patients
n=14 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
n=6 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Ulnar Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls
Day 0
|
2.36 mm^2
Standard Deviation 0.71
|
1.88 mm^2
Standard Deviation 0.65
|
|
Ulnar Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls
Day 7
|
2.25 mm^2
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 20 daysPopulation: Not applicable to the Control group.
Length of hospital stay is measured to the nearest day (by chart review).
Outcome measures
| Measure |
GBS Patients
n=14 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Length of Hospital Stay in Days
|
12.93 days
Standard Deviation 6.21
|
—
|
SECONDARY outcome
Timeframe: At discharge, up to approximately 20 daysPopulation: Not applicable to the Control group.
Number of participants with ambulatory status as "ambulatory with or without assistance".
Outcome measures
| Measure |
GBS Patients
n=14 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Ambulatory Status on Discharge
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: During admission, up to approximately 20 daysPopulation: Not applicable to the Control group.
Respiratory dysfunction will be measured by number of days intubated (to the nearest day) by chart review.
Outcome measures
| Measure |
GBS Patients
n=14 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Respiratory Dysfunction, as Measured by Number of Days Intubated
|
1.29 days
Standard Deviation 3.00
|
—
|
SECONDARY outcome
Timeframe: Day 0, Day 7Population: Participants with data collected at each time point. Not applicable to the Control group.
Average of left and right hand grip strength (in pounds).
Outcome measures
| Measure |
GBS Patients
n=13 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Strength, as Measured by Hand Dynamometer
Day 0
|
37.17 lbs
Standard Deviation 25.37
|
—
|
|
Strength, as Measured by Hand Dynamometer
Day 7
|
80.00 lbs
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Day 0, Day 7Population: Participants with data collected at each time point. Not applicable to the Control group.
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.
Outcome measures
| Measure |
GBS Patients
n=13 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Strength, as Measured by Medical Research Council (MRC)
Day 0
|
40.00 score on a scale
Standard Deviation 18.64
|
—
|
|
Strength, as Measured by Medical Research Council (MRC)
Day 7
|
56.00 score on a scale
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: During hospitalization, up to approximately 20 daysPopulation: Not applicable to the Control group.
Autonomic dysfunction will be either present or absent by chart review during hospitalization.
Outcome measures
| Measure |
GBS Patients
n=14 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Number of Participants With Autonomic Dysfunction
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0, Day 7, Discharge (up to approximately 20 days), Day 90, Day 180Population: Not applicable to the Control group. Only one participant had data collected at Day 7.
The GBS disability score ranges from 0-6 with lower scores indicating a better outcome (0 is healthy, 6 is death).
Outcome measures
| Measure |
GBS Patients
n=14 Participants
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
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.
|
Controls
Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
|
|---|---|---|
|
Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score
Discharge
|
3.14 score on a scale
Standard Deviation 0.95
|
—
|
|
Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score
Day 0
|
3.57 score on a scale
Standard Deviation 1.02
|
—
|
|
Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score
Day 7
|
3.00 score on a scale
Standard Deviation 0
|
—
|
|
Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score
Day 90
|
2.21 score on a scale
Standard Deviation 1.37
|
—
|
|
Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score
Day 180
|
1.64 score on a scale
Standard Deviation 1.45
|
—
|
Adverse Events
GBS Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place