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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsies, Partial
• Intervention / Treatment: Device: Near-infrared spectroscopy

Detailed Description

Pediatric subjects with partial (focal) epilepsy seizure disorders 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/cap/device 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.

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • The Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study subjects will include pediatric patients from 7 and older with a known seizure disorder. This study design is a prospective observational case-control where the subjects are their own controls. This is accomplished by comparing brain regions of electrical spikes to regions without spikes as measured by EEG and NIRS during resting state, structured task paradigm completion and, if seizure activity incidentally occurs during the study visit, NIRS data from brain regions of electrical spikes from seizure activity will be compared to other brain regions.

Description

Inclusion Criteria:

1. Pediatric epilepsy patients who can provide assent (lower limit age 7).
2. Diagnosis of partial (focal) epilepsy and/or frequent interictal spike activity on EEG.
3. Clinical EEG supporting diagnosis of partial(focal) epilepsy and/or frequent interictal spike activity

Exclusion Criteria:

1. History of unrepaired or palliated congenital cyanotic heart disease
2. History of traumatic head injury or head wounds to the extent that precludes safe and consistent placement of NIRS-EEG probes.
3. Guardian does not give consent or patient is unable to consent/assent to participate in the study
4. Clinical care provider or investigator determines the patient is not appropriate candidate for the study
5. Lack of current seizure care plan in Children's Hospital medical record
6. Known sensitivity or allergy to EEG gel

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epilepsy patients; Near-infrared spectroscopy for subjects with partial (focal) epilepsy seizures being studied in the EMU.	Device: Near-infrared spectroscopy; Measurement of CCO redox state and cerebral oxygenation during epileptic seizures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Marquette University
• Investigators: Principal Investigator: Rene Andrade-Machado, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: epilepsy; near-infrared spectroscopy; NIRS; partial epilepsy; regional cerebral oxygen saturation; childhood epilepsy; cytochrome oxidase redox state
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: PRO00046065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No