Trial Outcomes & Findings for Validation of Criteria for Identification of Epileptiform Discharges in EEG Recordings of Patients With Epilepsy (NCT NCT03533374)
NCT ID: NCT03533374
Last Updated: 2020-07-22
Results Overview
Inter-rater agreement of IFCN criteria (cut-off=4) in sensor space and of detection of EDs in source space was calculated using Gwet´s Agreemen Coefficient (AC1). We calculated Gwet's coefficients of agreement AC1 for beyond chance agreement, because, compared with Cohen's Kappa, the Gwet's agreement coefficient is less affected by prevalence and marginal probability and thereby avoids the problem known as the "paradoxes of kappa". Strength of agreement beyond chance was interpreted according to Landis and Koch criteria: poor (\<0), slight (0·01-0·20), fair (0·21-0·40), moderate (0·41-0·60), substantial (0·61-0·80), and almost perfect (0·81-1·00).
COMPLETED
100 participants
1 year
2020-07-22
Participant Flow
Participant milestones
| Measure |
Patients With Epileptic Seizures
Electroencephalogram (EEG) and visual evaluation
\- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
|
Patients With Non-epileptic Seizures
Electroencephalogram (EEG) and visual evaluation
\- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
46
|
|
Overall Study
COMPLETED
|
54
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of Criteria for Identification of Epileptiform Discharges in EEG Recordings of Patients With Epilepsy
Baseline characteristics by cohort
| Measure |
Patients With Epileptic Seizures
n=54 Participants
Electroencephalogram (EEG) and visual evaluation
\- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
|
Patients With Non-epileptic Seizures
n=46 Participants
Electroencephalogram (EEG) and visual evaluation
\- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 18.9 • n=5 Participants
|
37.6 years
STANDARD_DEVIATION 19.7 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 19.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
40 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
100 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
|
PRIMARY outcome
Timeframe: 1 yearInter-rater agreement of IFCN criteria (cut-off=4) in sensor space and of detection of EDs in source space was calculated using Gwet´s Agreemen Coefficient (AC1). We calculated Gwet's coefficients of agreement AC1 for beyond chance agreement, because, compared with Cohen's Kappa, the Gwet's agreement coefficient is less affected by prevalence and marginal probability and thereby avoids the problem known as the "paradoxes of kappa". Strength of agreement beyond chance was interpreted according to Landis and Koch criteria: poor (\<0), slight (0·01-0·20), fair (0·21-0·40), moderate (0·41-0·60), substantial (0·61-0·80), and almost perfect (0·81-1·00).
Outcome measures
| Measure |
Patients With Epileptic Seizures
n=54 Participants
Electroencephalogram (EEG) and visual evaluation
\- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
|
Patients With Non-epileptic Seizures
n=46 Participants
Electroencephalogram (EEG) and visual evaluation
\- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
|
|---|---|---|
|
Inter-rater Agreement of the International Federation of Clinical Neurophysiology (IFCN) Criteria (Cut-off=4) in Sensor Space and of Detection of Epileptiform Discharges (EDs) in Source Space
|
0.61 AC1 - agreement coefficient
Interval 0.53 to 0.69
|
0.59 AC1 - agreement coefficient
Interval 0.51 to 0.68
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Sensitivity is calculated in the epileptic group and specificity in the non-epileptic group.
This is a diagnostic study, hence sensitivity and specificity must be calculated from different groups: sensitivity form the group of patients with epilepsy and specificity from the gruoup of patients who do not have epilepsy. Sensitivity: the percentage of patients with abnormal index test (true positives) among patients with epilepsy. Specificity: the percentage of patients with normal index test (true negatives) among patients who do not have epilepsy.
Outcome measures
| Measure |
Patients With Epileptic Seizures
n=54 Participants
Electroencephalogram (EEG) and visual evaluation
\- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
|
Patients With Non-epileptic Seizures
n=46 Participants
Electroencephalogram (EEG) and visual evaluation
\- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
|
|---|---|---|
|
Sensitivity and Specificity IFCN Criteria (Cut-off=4)
|
96.3 percentage
Interval 87.3 to 99.6
|
84.8 percentage
Interval 71.1 to 93.7
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Sensitivity is calculated in the epileptic group and specificity in the non-epileptic group.
This is a diagnostic study, hence sensitivity and specificity must be calculated from different groups: sensitivity form the group of patients with epilepsy and specificity from the group of patients who do not have epilepsy. Sensitivity: the percentage of patients with abnormal index test (true positives) among patients with epilepsy. Specificity: the percentage of patients with normal index test (true negatives) among patients who do not have epilepsy.
Outcome measures
| Measure |
Patients With Epileptic Seizures
n=54 Participants
Electroencephalogram (EEG) and visual evaluation
\- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
|
Patients With Non-epileptic Seizures
n=46 Participants
Electroencephalogram (EEG) and visual evaluation
\- Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
Electroencephalogram (EEG) and visual evaluation: Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
|
|---|---|---|
|
The Sensitivity and Specificity of Detecting EDs in Source-space
|
85.2 percentage
Interval 72.9 to 93.4
|
95.7 percentage
Interval 85.2 to 99.5
|
Adverse Events
Patients With Epileptic Seizures
Patients With Non-epileptic Seizures
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