High Frequency Oscillation in Pediatric Epilepsy Surgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-29

Study Completion Date

2021-07-01

Brief Summary

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High Frequency Oscillation (HFO) on ElectroCorticoGraphy (ECoG) has been identified as a new biomarker for epileptogenic tissue. The purpose of this study is to see if epilepsy surgery guided by the combination of HFO on ECoG and standard clinical practice can result in a greater likelihood of seizure freedom, versus standard clinical practice alone, without HFOs.

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Detailed Description

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Intra-operative electrocorticography (ECoG), based on interictal spike and spike patterns, is performed to optimize delineation of the epileptogenic tissue in the operating room during epilepsy surgery. Similarly, extra-operative electrocorticography is often recorded over days to weeks with intracranial grids and depth electrodes, when the epileptogenic zone is not clearly localized with non-invasive studies and/or with intra-operative ECoG. Surgical resection following extra-operative ECoG is then "tailored' by the seizure onset zone as the gold standard.

High frequency oscillations have been identified as a more precise biomarker for epileptogenic tissue. The aim of this double-blind randomized surgical trial is to determine if HFO- tailored surgery combining HFOs and current standard of care, compared to current standard of care alone, will lead to a better seizure outcome.

Conditions

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Pediatric Epilepsy Epilepsy Surgery High Frequency Oscillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization into standard arm and the treatment arm in a 1:1 ratio.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

A double-blinded randomized control trial including children with refractory focal epilepsy who undergo surgery with intra- or extra-operative electrocorticography. Surgery is tailored by HFOs and standard ECoG interpretation (spikes on intra-operative ECoG or seizure onset on extra-operative ECoG) (arm 1), or tailored by standard ECoG alone (arm 2).

Informed consent will be obtained 1 to 7 days to up to 3 months prior to the day of surgery. Prior to surgery, the subject will be randomized into the cohort arms in a 1:1 ratio.

Blinding of the clinical neurophysiologists and neurosurgeons for treatment allocation is not feasible because of the character of the intervention. Therefore, this is a double-blinded trial as subjects will be blinded to the cohort arm to minimize bias of the follow-up results. The treating neurologist will also be blinded.

Study Groups

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Standard of Care PLUS HFO

Surgery is tailored by HFOs and standard ECoG interpretation (spikes on intra-operative ECoG or seizure onset on extra-operative ECoG) (arm 1).

Group Type EXPERIMENTAL

HFO analysis

Intervention Type DIAGNOSTIC_TEST

We hypothesize that the strategy of incorporating HFO data to a standard ECoG-guided resection in pediatric epilepsy surgery will result in improved postoperative seizure outcome than the traditional approach.

Standard of Care

Surgery is tailored by standard ECoG alone (arm 2).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HFO analysis

We hypothesize that the strategy of incorporating HFO data to a standard ECoG-guided resection in pediatric epilepsy surgery will result in improved postoperative seizure outcome than the traditional approach.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 0-21 years
* Refractory focal epilepsy
* Planned resective epilepsy neurosurgery
* Includes intraoperative or extraoperative electrocorticography with grids
* Planned resective epilepsy surgery approved by institutional surgery board

Exclusion Criteria

* Subjects undergoing non-resective neurosurgery
* Does not include intraoperative or extraoperative electrocorticography with grids
* Planned resective surgery is a hemispherectomy/hemispherotomy

Minimum Eligible Age

0 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No