High Frequency Oscillation in Pediatric Epilepsy Surgery

NCT03790280 | Completed Results DMC FDA Device

• 1 other identifier: HFO1001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Epilepsy; Epilepsy Surgery; High Frequency Oscillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-operative Complication

  1 year after surgery

Study Arms (2)

Standard of Care PLUS HFO

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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

Interventions

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.

Standard of Care PLUS HFO

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Subjects undergoing non-resective neurosurgery
• Does not include intraoperative or extraoperative electrocorticography with grids
• Planned resective surgery is a hemispherectomy/hemispherotomy

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095-1752, United States

Location

Results Point of Contact

• Title: Angela Martinez, Research Manager
• Organization: University of California, Los Angeles (UCLA)

angelamartinez@mednet.ucla.edu

310-206-7630

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization into standard arm and the treatment arm in a 1:1 ratio.

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 31, 2018
• Study Start: November 29, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 1, 2023
• Results First Posted: September 1, 2023

Record last verified: 2023-08

Locations

US (1)