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

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ClinicalTrials.gov Identifier: NCT03054961
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Harry T Whelan, MD, Medical College of Wisconsin

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.

Condition or disease Intervention/treatment
Epilepsies, Partial Device: Near-infrared spectroscopy

Detailed Description:
Pediatric subjects with partial (focal) epilepsy seizure disorders who are being admitted to the epilepsy monitoring unit 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 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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study - MULTICHANNEL NIRS for Epilepsy Seizure Detection
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : February 9, 2022
Estimated Study Completion Date : February 9, 2024


Group/Cohort Intervention/treatment
Epilepsy patients
Near-infrared spectroscopy for subjects with partial (focal) epilepsy seizures being studied in the EMU.
Device: Near-infrared spectroscopy
Measurement of CCO redox state and cerebral oxygenation during epileptic seizures.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study subjects will include pediatric patients from birth to 18 years of age with a known seizure disorder who are being admitted to the epilepsy monitoring unit (EMU) or the ICU for further workup or medication management of their epilepsy.
Criteria

Inclusion Criteria:

Study subjects will include pediatric patients from birth to 18 years of age with a known seizure disorder who are being admitted to the epilepsy monitoring unit (EMU) or the ICU for further workup or medication management of their epilepsy. Subject will be eligible for the study if:

  1. they have a diagnosis of partial (focal) epilepsy
  2. standard of care long- term EEG monitoring is planned
  3. during the past 3 days to 1 week prior to EMU admission, have had an average of at least one seizure per day at time of admission to EMU.

Exclusion Criteria:

  1. history of unrepaired or palliated congenital cyanotic heart disease
  2. history of traumatic head injury to the extent that precludes safe and consistent placement of NIRS-EEG probes.
  3. diagnosis of Primary generalized epilepsy
  4. Allergy or sensitivity to tape or adhesives
  5. Guardian or patient do not give consent/assent to participate in the study
  6. Clinical care provider or investigator determines the patient is not appropriate candidate for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054961


Contacts
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Contact: Harry T Whelan, MD 414-266-7540 hwhelan@mcw.edu

Locations
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United States, Wisconsin
The Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Harry T Whelan, MD    414-266-7540    hwhelan@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Harry T Whelan, MD Medical College of Wisconsin

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Responsible Party: Harry T Whelan, MD, Bleser Professor of Neurology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03054961     History of Changes
Other Study ID Numbers: 119371-19
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Harry T Whelan, MD, Medical College of Wisconsin:
epilepsy
cytochrome oxidase redox state
childhood epilepsy
partial epilepsy
NIRS
near-infrared spectroscopy
regional cerebral oxygen saturation
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases