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OpenTrials
Completed

NCT Number: NCT03790280

High Frequency Oscillation in Pediatric Epilepsy Surgery

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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Key information

Conditions

Pediatric Epilepsy Epilepsy Surgery High Frequency Oscillation

Age range

0 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095-1752, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Post-operative Seizure-free Rate

    Time frame: 1 year after surgery

    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.

Secondary outcomes

  1. Post-operative Complication

    Time frame: 1 year after surgery

    Number of participants experiencing surgical complications

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Acronym: HFO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 31, 2018
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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