Evaluation of Accuracy and Consistency of the X-Trodes System

B-Cube

Status: Completed

Conditions: Equipment and Supplies

Treatments: Device: X-Trodes acquisition system

Study type: Observational

Funder types: Other

Identifiers

NCT05722639

Pro00068380

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

57 participants in 1 patient group

Representative sample of the U.S. population

Description:

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.

Treatment:

Device: X-Trodes acquisition system