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

NCT05123469 | Unknown DMC FDA Device

• 1 other identifier: 2017110124
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Epilepsy; EEG; Wireless; Dry electrode; mobile

Outcome Measures

Primary Outcomes (1)

• Technical equivalence

  Equivalence of signal to noise ratio of EEG signal

  2022-2023

Secondary Outcomes (1)

• Clinical equivalence

  2022-2023

Interventions

Electroencephalography DEVICE

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

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with epilepsy

You may qualify if:

• Patients with the diagnosis of simple and multifocal seizure or generalized seizure who are at least 1 year old but 19 years old at most, whose head the zEEG headset fits, and who also produced sufficient seizure and normal activity EEG data. This age range is all-inclusive, because the actual patient selection will be based on the head-sizes that the zEEG system will fit to.

You may not qualify if:

• Patients younger than 1 year and older than 19 years, pseudo seizures, patients who did not generate normal EEG data or their EEG electrode setting is in conflict with the zEEG headset will be excluded. Patients who cannot keep the zEEG headset on their head will be excluded.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Related Links

• Zeto EEG system

MeSH Terms

Conditions

Epilepsy

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Zoltan Nadasdy, Ph.D.

CONTACT

323-697-6714; zoltan@utexas.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 17, 2021
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)