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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-10

Study Completion Date

2023-06-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsies, Partial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Epilepsy patients

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

Near-infrared spectroscopy

Intervention Type DEVICE

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

Interventions

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Near-infrared spectroscopy

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No