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

Completed

• Conditions: Epilepsies, Partial
• Interventions: Device: Near-infrared spectroscopy

• Registration Number: NCT03054961
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-02-10
• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Primary Completion: 2023-06-07
• Study Completion: 2023-06-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epilepsy patients	Near-infrared spectroscopy	Near-infrared spectroscopy for subjects with partial (focal) epilepsy seizures being studied in the EMU.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States