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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03054961
Enrollment
34
Registered
2017-02-16
Start date
2017-02-10
Completion date
2023-06-07
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsies, Partial

Keywords

epilepsy, cytochrome oxidase redox state, childhood epilepsy, partial epilepsy, NIRS, near-infrared spectroscopy, regional cerebral oxygen saturation

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 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.

Interventions

DEVICENear-infrared spectroscopy

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

Sponsors

Marquette University
CollaboratorOTHER
Medical College of Wisconsin
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in CCO redox state and oxygen saturation1 weekRegional 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026