CompletedNot Applicable

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

United States34 participantsStarted 2017-02-10

Plain-language 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.

Who can participate

Age range

7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in CCO redox state and oxygen saturation

Timeframe: 1 week

Trial details

NCT IDNCT03054961

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-07

View on ClinicalTrials.gov More Epilepsies, Partial trials