High Frequency Oscillation in Pediatric Epilepsy Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
High Frequency Oscillation in Pediatric Epilepsy Surgery

Conditions
-----------------
Pediatric Epilepsy, Epilepsy Surgery, High Frequency Oscillation

Intervention / Treatment
-----------------
* Diagnostic Test: HFO analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization into standard arm and the treatment arm in a 1:1 ratio.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard of Care PLUS HFO<br>Surgery is tailored by HFOs and standard ECoG interpretation (spikes on intra-operative ECoG or seizure onset on extra-operative ECoG) (arm 1). | Diagnostic Test: HFO analysis<br>* 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.<br>|
| No Intervention: Standard of Care<br>Surgery is tailored by standard ECoG alone (arm 2). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Seizure-free Rate | The primary outcome measure is the number of patients seizure-free after surgery in the treatment arm of combined HFO and standard of care, compared to the number of patients seizure-free in the control arm of standard of care alone, at 1 year after surgery. | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Complication | Number of participants experiencing surgical complications | 1 year after surgery |