Pediatric EEG Monitoring

• Sponsor: Northwestern University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04664608
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric ALL; Epilepsy	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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of a Wireless EEG Monitor for Pediatric Patients
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Outcome Measures

Primary Outcome Measures

1. Percent Agreement [3 years]

   Percent agreement between experimental sensor and commercially available electroencephalogram (EEG)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shuai (Steve) Xu, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT04664608
• Other Study ID Numbers: 2020-3266
• First Posted: Dec 11, 2020
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epilepsy

Study Results

No Results Posted as of Apr 20, 2022