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

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

Sponsors

Lead Sponsor: Medical College of Wisconsin

Collaborator: Marquette University

Source Medical College of Wisconsin
Brief 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.

Detailed 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.

Overall Status Suspended
Start Date February 10, 2017
Completion Date February 9, 2024
Primary Completion Date February 9, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Change in CCO redox state and oxygen saturation 1 week
Enrollment 40
Condition
Intervention

Intervention Type: Device

Intervention Name: Near-infrared spectroscopy

Description: Measurement of CCO redox state and cerebral oxygenation during epileptic seizures.

Arm Group Label: Epilepsy patients

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Harry T Whelan, MD Principal Investigator Medical College of Wisconsin
Location
Facility: The Medical College of Wisconsin
Location Countries

United States

Verification Date

May 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Medical College of Wisconsin

Investigator Full Name: Harry T Whelan, MD

Investigator Title: Bleser Professor of Neurology

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Epilepsy patients

Description: Near-infrared spectroscopy for subjects with partial (focal) epilepsy seizures being studied in the EMU.

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov