NCT05722639

Evaluation of Accuracy and Consistency of the X-Trodes System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: B-Cube · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Equipment and Supplies

Interventions

Type	Name	Description
DEVICE	X-Trodes acquisition system	No intervention. The participants will sit passively while electrophysiology signals are captured from two devices in order to evaluate the signal quality.

Timeline

• Start date: 2023-01-23
• Primary completion: 2023-03-31
• Completion: 2024-01-04
• First posted: 2023-02-10
• Last updated: 2024-03-01

Locations

1 site across 1 country: United States