Guillain-Barre Syndrome
Conditions
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.
Interventions
DIAGNOSTIC_TESTPeripheral nerve ultrasound
Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
DIAGNOSTIC_TESTMeasurement 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.
Sponsors
GBS-CIDP foundation
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
The EMG lab physician or technician performing the ultrasound will be blinded to the EMG/NCS results.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Strength, as Measured by Hand Dynamometer | Day 0, Day 7 | Average of left and right hand grip strength (in pounds). |
| Strength, as Measured by Medical Research Council (MRC) | 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. |
| Length of Hospital Stay in Days | Up to approximately 20 days | Length of hospital stay is measured to the nearest day (by chart review). |
| Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score | 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). |
| Number of Participants With Autonomic Dysfunction | During hospitalization, up to approximately 20 days | Autonomic dysfunction will be either present or absent by chart review during hospitalization. |
| Ambulatory Status on Discharge | At discharge, up to approximately 20 days | Number of participants with ambulatory status as ambulatory with or without assistance. |
| Respiratory Dysfunction, as Measured by Number of Days Intubated | During admission, up to approximately 20 days | Respiratory dysfunction will be measured by number of days intubated (to the nearest day) by chart review. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Controls Peripheral nerve ultrasound: Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed. | 6 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Time restraint due to inpatient needs | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | GBS Patients | Total | Controls |
|---|---|---|---|
| Age, Continuous | 57.71 years STANDARD_DEVIATION 13.93 | 58.23 years STANDARD_DEVIATION 14.33 | 59.30 years STANDARD_DEVIATION 15.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 12 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 8 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 18 Participants | 5 Participants |
| Region of Enrollment United States | 14 Participants | 20 Participants | 6 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Day 0 and approximately 7 days after admission
Population: Participants with data collected at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBS Patients | Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls | Day 0 | 1.82 mm^2 | Standard Deviation 0.43 |
| GBS Patients | Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls | Day 7 | 1.38 mm^2 | Standard Deviation 0 |
| Controls | Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls | Day 0 | 1.49 mm^2 | Standard Deviation 0.31 |
Primary
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.
Time frame: Day 0 and approximately 7 days after admission
Population: Participants with data collected at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBS Patients | Median Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls | Day 0 | 1.96 mm^2 | Standard Deviation 0.51 |
| GBS Patients | Median Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls | Day 7 | 1.63 mm^2 | Standard Deviation 0 |
| Controls | Median Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls | Day 0 | 1.73 mm^2 | Standard Deviation 0.56 |
Primary
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.
Time frame: Day 0 and approximately 7 days after admission
Population: Participants with data collected at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBS Patients | Ulnar Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls | Day 0 | 2.36 mm^2 | Standard Deviation 0.71 |
| GBS Patients | Ulnar Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls | Day 7 | 2.25 mm^2 | Standard Deviation 0 |
| Controls | Ulnar Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls | Day 0 | 1.88 mm^2 | Standard Deviation 0.65 |
Secondary
Ambulatory Status on Discharge
Number of participants with ambulatory status as ambulatory with or without assistance.
Time frame: At discharge, up to approximately 20 days
Population: Not applicable to the Control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBS Patients | Ambulatory Status on Discharge | 6 Participants |
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.36Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.521Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.245Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.541Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.415Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.504Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.393Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.222Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.615Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.926Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.519Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.379Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).p-value: 0.511Regression, Logistic
Secondary
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).
Time frame: Day 0, Day 7, Discharge (up to approximately 20 days), Day 90, Day 180
Population: Not applicable to the Control group. Only one participant had data collected at Day 7.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBS Patients | Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score | Day 0 | 3.57 score on a scale | Standard Deviation 1.02 |
| GBS Patients | Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score | Day 7 | 3.00 score on a scale | Standard Deviation 0 |
| GBS Patients | Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score | Discharge | 3.14 score on a scale | Standard Deviation 0.95 |
| GBS Patients | Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score | Day 90 | 2.21 score on a scale | Standard Deviation 1.37 |
| GBS Patients | Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score | Day 180 | 1.64 score on a scale | Standard Deviation 1.45 |
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.2344, 0.7511]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.4859, 0.5555]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.3342, 0.417]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.6473, 0.2723]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.583, 0.4451]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.3592, 0.6944]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.5145, 0.4627]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.5056, 0.4833]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.5876, 0.3467]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.3682, 0.3885]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.422, 0.6686]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.5651, 0.454]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.95% CI: [-0.549, 0.238]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.95% CI: [-0.1865, 0.643]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.95% CI: [-0.5806, 0.4223]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.95% CI: [-0.5619, 0.5236]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.95% CI: [-0.2488, 0.7683]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.95% CI: [-0.2573, 0.6027]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.95% CI: [-0.2595, 0.6227]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.95% CI: [-0.5757, 0.3944]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.95% CI: [-0.1828, 0.555]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.95% CI: [-0.3557, 0.7344]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.95% CI: [-0.615, 0.5083]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.95% CI: [-0.5042, 0.3963]
Secondary
Length of Hospital Stay in Days
Length of hospital stay is measured to the nearest day (by chart review).
Time frame: Up to approximately 20 days
Population: Not applicable to the Control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GBS Patients | Length of Hospital Stay in Days | 12.93 days | Standard Deviation 6.21 |
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.5005, 0.4791]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.6503, 0.4222]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.549, 0.1829]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.3411, 0.5017]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.4335, 0.5592]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.5092, 0.304]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.3057, 0.4137]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.4028, 0.57]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.6503, 0.2838]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.5714, 0.195]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.4667, 0.3336]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.7018, 0.3193]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.95% CI: [-0.3506, 0.4596]
Secondary
Number of Participants With Autonomic Dysfunction
Autonomic dysfunction will be either present or absent by chart review during hospitalization.
Time frame: During hospitalization, up to approximately 20 days
Population: Not applicable to the Control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBS Patients | Number of Participants With Autonomic Dysfunction | 5 Participants |
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.548Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.548Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.25Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.874Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.698Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.665Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.82Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.193Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.314Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.405Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.389Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.139Regression, Logistic
Comparison: Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).p-value: 0.622Regression, Logistic
Secondary
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.
Time frame: During admission, up to approximately 20 days
Population: Not applicable to the Control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GBS Patients | Respiratory Dysfunction, as Measured by Number of Days Intubated | 1.29 days | Standard Deviation 3 |
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.4273, 0.3293]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.548, 0.5248]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.1938, 0.4763]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.6811, -0.0874]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.7032, 0.1185]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.7112, -0.1978]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.2201, 0.5014]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.0679, 0.6612]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.4213, 0.361]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.5389, 0.2057]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.6539, 0.2288]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.686, -0.2065]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.95% CI: [-0.6487, 0]
Secondary
Strength, as Measured by Hand Dynamometer
Average of left and right hand grip strength (in pounds).
Time frame: Day 0, Day 7
Population: Participants with data collected at each time point. Not applicable to the Control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBS Patients | Strength, as Measured by Hand Dynamometer | Day 0 | 37.17 lbs | Standard Deviation 25.37 |
| GBS Patients | Strength, as Measured by Hand Dynamometer | Day 7 | 80.00 lbs | Standard Deviation 0 |
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.5288, 0.5485]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.735, 0.4247]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.4377, 0.8004]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.5256, 0.3778]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.3591, 0.5606]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.3901, 0.6374]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.5773, 0.5407]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.6968, 0.2414]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.5204, 0.6392]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.4633, 0.5594]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.6816, 0.1857]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.4476, 0.4025]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.95% CI: [-0.3506, 0.4596]
Secondary
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.
Time frame: Day 0, Day 7
Population: Participants with data collected at each time point. Not applicable to the Control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBS Patients | Strength, as Measured by Medical Research Council (MRC) | Day 0 | 40.00 score on a scale | Standard Deviation 18.64 |
| GBS Patients | Strength, as Measured by Medical Research Council (MRC) | Day 7 | 56.00 score on a scale | Standard Deviation 0 |
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.395, 0.6584]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.395, 0.6584]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.3821, 0.5979]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.4158, 0.479]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.5033, 0.443]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.5458, 0.4037]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.6514, 0.2935]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.5371, 0.2974]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.2791, 0.7651]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.4531, 0.5267]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.2786, 0.4454]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.2459, 0.6708]
Comparison: Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.95% CI: [-0.2333, 0.4899]