Evaluation of Accuracy and Consistency of the X-Trodes System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Accuracy and Consistency of the X-Trodes System

Conditions
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Equipment and Supplies

Intervention / Treatment
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* Device: X-Trodes acquisition system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in the study, subjects must meet all the following inclusion criteria: Adults (age 21 - 99) Referred to an electrophysiology test by either neurologist or cardiologist in the last 5 years Produce interpretable electrophysiological signals by the acquisition devices Exclusion Criteria: Did not sign the informed consent Cannot maintain the electrodes attached to their skin (i.e., due to beard on the chin area) Diagnosed as suffering from sleep apnea Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Representative sample of the U.S. population<br>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. | Device: X-Trodes acquisition system<br>* No intervention. The participants will sit passively while electrophysiology signals are captured from two devices in order to evaluate the signal quality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrophysiology, Electrooculography, Electromyography, Electrocardiogram, Device, Acquisition