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| Name | Class |
|---|---|
| X-Trodes | UNKNOWN |
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The purpose of this study is to evaluate the accuracy and consistency of the X-Trodes acquisition system compared to a Food and Drug Administration (FDA)-cleared clinical electrophysiology device.
The study aims to demonstrate that the performance of the study X-Trodes acquisition system is equivalent to that of an FDA-cleared clinical electrophysiology devices (in measuring electroencephalography , electrooculography, electromyography, and electrocardiogram signals).
Subjects will wear both devices simultaneously while signals are captured in resting state. Following, an evaluation of the similarity of signals between the two devices will be conducted. The evaluation will determine if the quality of the X-Trodes system matches that of the FDA-approved device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Representative sample of the U.S. population | Subjects will be fitted with two electrophysiology acquisition systems (one is FDA-approved, and the other is the one evaluated). Signals from both systems will be acquired simultaneously while the subjects rest and perform no cognitive tasks. Following, the signals from both devices will be assessed by an electrophysiology expert to determine if they are of equal quality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X-Trodes acquisition system | Device | No intervention. The participants will sit passively while electrophysiology signals are captured from two devices in order to evaluate the signal quality. |
| Measure | Description | Time Frame |
|---|---|---|
| Signals alignment between two devices | Electrophysiological time-series (EEG, EOG, ECG, EMG) in 2 recorded devices will be compared. For each subject, the time-series from 2 devices will be assessed by three independent raters (US board-certified neurologist/cardiologist). The raters will rank the quality of signals (1-signal is corrupt or unusable; 5-signal is clean and useable). Raters will be blind to the signal device. Time-series will be deemed interpretable if at least 2 of the raters scored it 4-5. Following the rater evaluation, the outcome will also be reported as a binary output where scores of 4-5 are considered interpretable signals. The trial will be considered successful if the number of high-quality (mean score 4-5) X-Trode series will be within one-standard deviation from the FDA-approved device's series while both systems yield over 80% high-quality signals. | Within 3 months from the completion of data collection. |
| Assessment of agreement among raters | Agreement among raters will be evaluated by calculating the Intraclass correlation coefficient (ICC). ICC will be calculated for each of the 4 electrophysiological modalities. The acceptance criterion for ICC is 0.60 and higher. If no agreement among rates is observed (ICC < 0.6) then Spearman correlation coefficient between each pair of raters for the specific signal (per subect, per time-series) will be calculated and the rankings of the two raters with the highest correlation coefficient will be selected for the analysis. | Within 3 months from the completion of data collection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjects descriptive statistics | Description of subjects demographics, age, race, and gender will be reported. | 1 month after completion of data collection. |
| Signal descriptive statistics | For the continuous electrophysiological data collected, summary table with sample size, mean, standard deviation of the signal for each subject and for the entire subjects cohort, median activity for each individual signal electrophysiological time-series, minimum, and maximum values will be reported. |
Inclusion Criteria:
To be included in the study, subjects must meet all the following inclusion criteria:
Exclusion Criteria:
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Healthy individuals ages 21 and over who are able to come to the study site and sit for about 30 minutes while two electrophysiology devices are capturing EEG, EOG, EMG, ECG signals from their body. Subjects should have no beard (to ease the signal capturing), not be pregnant, not suffer from sleep apnea, and comfortable with the study protocol (i.e., sign a consent form).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| B-Cube | Chicago | Illinois | 60607 | United States |
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| 1 month after completion of data collection. |
| Study descriptive statistics | ounts and percentage of any adverse events by type (ADE, SADE, ASADE, and USADE/UADE) will be tabulated. | 1 month after completion of data collection. |