NCT03790280

High Frequency Oscillation in Pediatric Epilepsy Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 0 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Epilepsy
• Epilepsy Surgery
• High Frequency Oscillation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2018-11-29
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2018-12-31
• Last updated: 2023-09-01
• Results posted: 2023-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study