Epilepsies, PartialNCT03054961
Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study
An observational study of Epilepsies, Partial, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Epilepsies, Partial
- What is being tested?
- Near-infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2017to 7 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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
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.
Read the 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.
- Conditions
- Epilepsies, Partial
- Being tested
- Near-infrared spectroscopy
- Keywords
- epilepsy, cytochrome oxidase redox state, childhood epilepsy, partial epilepsy, NIRS, near-infrared spectroscopy, regional cerebral oxygen saturation
- Medical subject headings
- Epilepsies, Partial, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopyDevice
Measurement of CCO redox state and cerebral oxygenation during epileptic seizures.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy patients | Near-infrared spectroscopy for subjects with partial (focal) epilepsy seizures being studied in the EMU. Receives: Device: Near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start10 Feb 2017
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University
- Responsible party
- Principal investigator, Rene Andrade-Machado, Medical College of Wisconsin
- Investigators
- Rene Andrade-Machado, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054961
- Sponsor's protocol ID
- PRO00046065
- Status last verified
- Jul 2024
- First submitted
- 10 Feb 2017
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03054961
- Acronym / sponsor ID
- PRO00046065
- Conditions
- Epilepsies, Partial
- Keywords
- epilepsy, cytochrome oxidase redox state, childhood epilepsy, partial epilepsy, NIRS, near-infrared spectroscopy, regional cerebral oxygen saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Marquette University
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epilepsy patients | – | Device: Near-infrared spectroscopyNear-infrared spectroscopy for subjects with partial (focal) epilepsy seizures being studied in the EMU. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-infrared spectroscopyMeasurement of CCO redox state and cerebral oxygenation during epileptic seizures. | Device | Epilepsy patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rene Andrade-Machado, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsies, Partial, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CCO redox state and oxygen saturation (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.