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

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Suspended
• CT.gov ID: NCT03054961
• Collaborator: Marquette University (Other)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 96
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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 Near-infrared Spectroscopy (NIRS) for Epilepsy Seizure Detection
• Actual Study Start Date: Feb 10, 2017
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Feb 9, 2025

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Change in CCO redox state and oxygen saturation [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Medical College of Wisconsin
• Marquette University

Investigators

• Principal Investigator: Harry T Whelan, MD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Harry T Whelan, MD, Bleser Professor of Neurology, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT03054961
• Other Study ID Numbers: 119371-19
• First Posted: Feb 16, 2017
• Last Update Posted: Apr 11, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Harry T Whelan, MD, Bleser Professor of Neurology, 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: Epilepsy; Epilepsies, Partial

Study Results

No Results Posted as of Apr 11, 2022