High Frequency Oscillation in Pediatric Epilepsy Surgery (HFO)

• ClinicalTrials.gov Identifier: NCT03790280
• Recruitment Status: Active, not recruiting
• First Posted: December 31, 2018
• Last Update Posted: April 9, 2021
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): University of California, Los Angeles

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pediatric Epilepsy; Epilepsy Surgery; High Frequency Oscillation	Diagnostic Test: HFO analysis	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomization into standard arm and the treatment arm in a 1:1 ratio.
• Masking: Double (Participant, Care Provider)

Masking Description

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.

• Primary Purpose: Treatment
• Official Title: High Frequency Oscillation in Pediatric Epilepsy Surgery
• Actual Study Start Date: November 29, 2018
• Estimated Primary Completion Date: May 31, 2021
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	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.
No Intervention: Standard of Care; Surgery is tailored by standard ECoG alone (arm 2).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Post-operative complication rate [ Time Frame: 1 year after surgery ]
   Rates of surgical complication between the treatment arm (HFO and standard of care) will be compared to the control arm (standard of care only), including neurologic deficits and infection rate.

Eligibility Criteria

• Ages Eligible for Study: up to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

University of California, Los Angeles

Los Angeles, California, United States, 90095-1752

Sponsors and Collaborators

University of California, Los Angeles

More Information

• Responsible Party: University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03790280
• Other Study ID Numbers: HFO1001
• First Posted: December 31, 2018
• Last Update Posted: April 9, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases