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Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study | Clinical Trials | Clareo Health

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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

NCT03054961•Medical College of Wisconsin

View on ClinicalTrials.gov

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 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.

Eligibility

Age

7 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

February 10, 2017

Primary Completion Date

June 7, 2023

Completion Date

June 7, 2023

Last Updated

July 5, 2024

Enrollment

ACTUAL participants

Conditions

Epilepsies, Partial

Interventions

Near-infrared spectroscopy

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Contribution of Genetics, Non-invasive Methods and Neuropsychology in Focal Cryptogenic Epilepsies

Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy

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