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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care PLUS HFO | Experimental | Surgery is tailored by HFOs and standard ECoG interpretation (spikes on intra-operative ECoG or seizure onset on extra-operative ECoG) (arm 1). |
|
| Standard of Care | No Intervention | Surgery is tailored by standard ECoG alone (arm 2). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFO analysis | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Complication | Number of participants experiencing surgical complications | 1 year after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095-1752 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). 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. |
| FG001 | Standard of Care | Surgery is tailored by standard ECoG alone (arm 2). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 1 year after surgery |
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Adverse events were collected post-operatively for up to 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care PLUS HFO | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subdural Hematoma | Injury, poisoning and procedural complications | SNOMED CT | Systematic Assessment | Perioperative unwitnessed fall resulted in left subdural hematoma requiring evacuation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Martinez, Research Manager | University of California, Los Angeles (UCLA) | 310-206-7630 | angelamartinez@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2017 | Apr 1, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2017 | Apr 1, 2022 | SAP_001.pdf |
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Randomization into standard arm and the treatment arm in a 1:1 ratio.
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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.
| BG001 | Standard of Care | Surgery is tailored by standard ECoG alone (arm 2). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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Surgery is tailored by standard ECoG alone (arm 2). |
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| Secondary | Post-operative Complication | Number of participants experiencing surgical complications | Posted | Count of Participants | Participants | 1 year after surgery |
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| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Standard of Care | Surgery is tailored by standard ECoG alone (arm 2). | 0 | 9 | 0 | 9 | 0 | 9 |
|
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