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

NCT03054961 | Completed FDA Device

• 1 other identifier: PRO00046065
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsies, Partial

Keywords

epilepsy; cytochrome oxidase redox state; childhood epilepsy; partial epilepsy; NIRS; near-infrared spectroscopy; regional cerebral oxygen saturation

Outcome Measures

Primary Outcomes (1)

• Change in CCO redox state and oxygen saturation

  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.

  1 week

Study Arms (1)

Epilepsy patients

Near-infrared spectroscopy for subjects with partial (focal) epilepsy seizures being studied in the EMU.

Device: Near-infrared spectroscopy

Interventions

Near-infrared spectroscopy DEVICE

Measurement of CCO redox state and cerebral oxygenation during epileptic seizures.

Epilepsy patients

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects will include pediatric patients from 7 and older with a known seizure disorder. This study design is a prospective observational case-control where the subjects are their own controls. This is accomplished by comparing brain regions of electrical spikes to regions without spikes as measured by EEG and NIRS during resting state, structured task paradigm completion and, if seizure activity incidentally occurs during the study visit, NIRS data from brain regions of electrical spikes from seizure activity will be compared to other brain regions.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Marquette University: collaborator

Study Sites (1)

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Rene Andrade-Machado, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 16, 2017
• Study Start: February 10, 2017
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)