High Frequency Oscillation in Pediatric Epilepsy Surgery

Pediatric Epilepsy Clinical Trial

— HFO  

Official title:

High Frequency Oscillation in Pediatric Epilepsy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790280
• Other study ID #: HFO1001
• Status: Completed
• Phase: N/A
• Start date: November 29, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy Surgery
• High Frequency Oscillation
• Pediatric Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 year after surgery
Secondary	Post-operative Complication	Number of participants experiencing surgical complications	1 year after surgery