High Frequency Oscillation in Pediatric Epilepsy Surgery (HFO)

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Pediatric Epilepsy; Epilepsy Surgery; High Frequency Oscillation

Treatments: Diagnostic Test: HFO analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03790280

HFO1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 2 patient groups

Standard of Care PLUS HFO

Experimental group

Description:

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

Treatment:

Diagnostic Test: HFO analysis

Standard of Care

No Intervention group

Description:

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