Evaluation of Accuracy and Consistency of the X-Trodes System

NCT05722639 | Completed

• 1 other identifier: Pro00068380
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Equipment and Supplies

Keywords

Electrophysiology; Electrooculography; Electromyography; Electrocardiogram; Device; Acquisition

Outcome Measures

Primary Outcomes (2)

• 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.

Other Outcomes (3)

• Subjects descriptive statistics

  1 month after completion of data collection.

• Signal descriptive statistics

  1 month after completion of data collection.

• Study descriptive statistics

  1 month after completion of data collection.

Study Arms (1)

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.

Device: X-Trodes acquisition system

Interventions

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.

Representative sample of the U.S. population

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• B-Cube: lead
• X-Trodes: collaborator

Study Sites (1)

B-Cube

Chicago, Illinois, 60607, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 10, 2023
• Study Start: January 23, 2023
• Primary Completion: March 31, 2023
• Study Completion: January 4, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)