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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

Tracking Information
First Submitted Date February 10, 2017
First Posted Date February 16, 2017
Last Update Posted Date April 24, 2019
Actual Study Start Date February 10, 2017
Estimated Primary Completion Date February 9, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03054961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study
Official Title Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study - MULTICHANNEL NIRS for Epilepsy Seizure Detection
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 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Epilepsies, Partial
Intervention Device: Near-infrared spectroscopy
Measurement of CCO redox state and cerebral oxygenation during epileptic seizures.
Study Groups/Cohorts Epilepsy patients
Near-infrared spectroscopy for subjects with partial (focal) epilepsy seizures being studied in the EMU.
Intervention: Device: Near-infrared spectroscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 13, 2017)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 9, 2024
Estimated Primary Completion Date February 9, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Harry T Whelan, MD 414-266-7540 hwhelan@mcw.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03054961
Other Study ID Numbers 119371-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Harry T Whelan, MD, Medical College of Wisconsin
Study Sponsor Medical College of Wisconsin
Collaborators Not Provided
Investigators
Principal Investigator: Harry T Whelan, MD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date April 2019