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Clinical Trials/NCT03054961
NCT03054961
Completed
Not Applicable

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

Medical College of Wisconsin1 site in 1 country34 target enrollmentFebruary 10, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsies, Partial
Sponsor
Medical College of Wisconsin
Enrollment
34
Locations
1
Primary Endpoint
Change in CCO redox state and oxygen saturation
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 10, 2017
End Date
June 7, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rene Andrade-Machado

Assistant Professor

Medical College of Wisconsin

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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