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Completed

NCT Number: NCT03054961

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

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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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Near-infrared spectroscopy

Device

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

Primary outcomes

  1. Change in CCO redox state and oxygen saturation

    Time frame: 1 week

    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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Marquette University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2017
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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