Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study

Epilepsies, Partial Clinical Trial

Official title:

Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study - Multichannel Near-infrared Spectroscopy (NIRS) for Epilepsy Seizure Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03054961
• Other study ID #: 119371-19
• Status: Recruiting
• Start date: February 10, 2017
• Est. completion date: February 9, 2025

Study information

• Verified date: August 2023
• Source: Medical College of Wisconsin
• Contact: Rebecca Rehborg
• Phone: 414-266-3355
• Email: rrehborg[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this pilot study is to describe the relationship of regional cerebral oximetry and cytoximetry, measured using near-infrared spectroscopy, with seizure activity in the periictal period in children with epilepsy.

Description:

Pediatric subjects with partial (focal) epilepsy seizure disorders who are being admitted to the epilepsy monitoring unit will be studied using near-infrared spectroscopy for cytochrome c oxidase (CCO) redox state and blood oxygen saturation. Along with routine EEG monitoring, a set of light sensors, called optodes, attached to a net that goes over the head will be put on. These optodes will send out very weak red light signals, which will pass through the scalp and bounce back to detectors on the netting. The changes in the light signals will be used to calculate the changes in the various forms of the enzyme CCO, as well as the amount of oxygen in the blood. We hope to use these measurements to study changes in blood flow and cellular energy usage in the brain during seizures, which might help us to understand epilepsy better in the future and design better treatments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 9, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

Study subjects will include pediatric patients from birth to 18 years of age with a known seizure disorder who are being admitted to the epilepsy monitoring unit (EMU) or the ICU for further workup or medication management of their epilepsy. Subject will be eligible for the study if:

1. they have a diagnosis of partial (focal) epilepsy

2. standard of care long- term EEG monitoring is planned

3. during the past 3 days to 1 week prior to EMU admission, have had an average of at least one seizure per day at time of admission to EMU.

Exclusion Criteria:

1. history of unrepaired or palliated congenital cyanotic heart disease

2. history of traumatic head injury to the extent that precludes safe and consistent placement of NIRS-EEG probes.

3. diagnosis of Primary generalized epilepsy

4. Allergy or sensitivity to tape or adhesives

5. Guardian or patient do not give consent/assent to participate in the study

6. Clinical care provider or investigator determines the patient is not appropriate candidate for the study

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

Device:
• Near-infrared spectroscopy
Measurement of CCO redox state and cerebral oxygenation during epileptic seizures.

Locations

Country	Name	City	State
United States	The Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Marquette University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CCO redox state and oxygen saturation	Regional cerebral saturation of oxygen and/or cytochrome oxidase redox state will change prior, during, and after onset of seizure activity when compared to non-seizure side of brain.	1 week