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Completed

NCT Number: NCT05722639

Evaluation of Accuracy and Consistency of the X-Trodes System

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.

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Key information

Conditions

Equipment and Supplies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

B-Cube

Chicago, Illinois, 60607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Signals alignment between two devices

    Time frame: Within 3 months from the completion of data collection.

    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.

  2. Assessment of agreement among raters

    Time frame: Within 3 months from the completion of data collection.

    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.

Other outcomes

  1. Subjects descriptive statistics

    Time frame: 1 month after completion of data collection.

    Description of subjects demographics, age, race, and gender will be reported.

  2. Signal descriptive statistics

    Time frame: 1 month after completion of data collection.

    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.

  3. Study descriptive statistics

    Time frame: 1 month after completion of data collection.

    ounts and percentage of any adverse events by type (ADE, SADE, ASADE, and USADE/UADE) will be tabulated.

Sponsors and collaborators

Lead sponsor

B-Cube

Other

Collaborators

  • X-Trodes

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 10, 2023
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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