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Clinical Validation of zEEG, a Wireless EEG Recording System for Pediatric and Adult Patients With Epilepsy

NCT05123469 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2021-11-17

No results posted yet for this study

Summary

The purpose of this study is to compare the standard clinical electroencephalography (EEG) device with a new portable wireless EEG device, further referred to as zEEG, made by ZETO®. zEEG was designed to make EEG studies simpler, safer, more comfortable, faster, and less obstructive for the patient, also easier to set up for technicians. Wireless and battery powered, it uses the latest mobile technology. Contrary to the clinical EEG, this headset does not use any glue between the skin and the electrodes. Minor skin irritation may still occur but much less likely than from the collodion glue used in the clinical electrodes. In addition, the zEEG system does not need any gel to be applied to the skin. The zEEG electrodes are dry and disposable. They have never been used on any other head before. No additional risk is involved with setting it up. In addition to the clinically necessary EEG electrodes or intracranial electrodes for long term monitoring, we will place zEEG on the head to compare the sensitivity of the new device to the traditional device. zEEG is proven to meet the standard of clinical system and received an FDA clearance in 2018. If further clinical tests validate its technical parameters and comfort, it may replace traditional clinical EEG systems.

Conditions

  • Epilepsy
  • EEG With Periodic Abnormalities
  • EEG With Abnormally Slow Frequencies
  • EEG; Paroxysms, Occipital, Epilepsy of Childhood
  • EEG; Spikes, Centrotemporal, Epilepsy of Childhood

Interventions

DEVICE

Electroencephalography

Simultaneous recording of electroencephalogram by conventional EEG device and the Zeto EEG device

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Eligibility

Min Age
1 Year
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-12-31
Completion
2023-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05123469 on ClinicalTrials.gov