Pediatric EEG Monitoring

Epilepsy Clinical Trial

Official title:

Evaluation of a Wireless EEG Monitor for Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664608
• Other study ID #: 2020-3266
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: November 27, 2023

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to understand if a new, smart, wireless EEG developed by our team can be used to monitor the continuous electrical activity of the brain in the ICU and EMU and whether it works as well as the current standard, wired EEGs.

Description:

The investigators propose to 1) optimize these devices for use in pediatric ICU patients, 2) demonstrate safety, reliability, and accuracy of these devices for continuous ICU EEG signal measurements, and 3) demonstrate these devices are preferred by patients and parents to current EEG devices. Once validated, such sensors could fundamentally change the way patients are monitored by EEG in the ICU, allowing wireless, continuous, real-time detection of brain wave activity in ICU patients, reducing limitations in mobility as well as access by staff and caregivers to the patient, and ultimately offering opportunity to reduce morbidity and mortality in ICU patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 27, 2023
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

Inclusion Criteria:

• Participants must be admitted to the PICU or EMU at Lurie Children's and are prescribed an EEG as part of their standard of care.

Exclusion Criteria:

• Anyone with a skin abnormality that would potentially increase the risk of device use will be excluded.

• Ages 18 years or older.

• Any patient or family determined by an attending physician or bedside care team to be too unstable (patient) or experiencing too much stress (family) will not be approached for recruitment.

Related Conditions & MeSH terms

• Epilepsy
• Pediatric ALL

Intervention

Device:
• wearable EEG sensor
Wireless wearable EEG devices offer a new, non-invasive, and easy way of performing EEG monitoring.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Agreement	Percent agreement between experimental sensor and commercially available electroencephalogram (EEG)	3 years