Pediatric EEG Monitoring

Evaluation of a Wireless EEG Monitor for Pediatric Patients

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Pediatric ALL
• Intervention / Treatment: Device: wearable EEG sensor

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

children between the ages of 0 and 18 years of age who are prescribed an EEG while admitted to the pediatric intensive care unit (PICU) or Epilepsy Monitoring Unit (EMU)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Agreement	Percent agreement between experimental sensor and commercially available electroencephalogram (EEG)	3 years

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 23, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 2020-3266

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No