Utilization of High-Frequency Oscillations in Pediatric Epilepsy Surgery: A Prospective, Double-blinded, Randomized Controlled Pilot Study
Abstract number :
2.262
Submission category :
9. Surgery / 9B. Pediatrics
Year :
2021
Submission ID :
1825794
Source :
www.aesnet.org
Presentation date :
12/5/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:50 AM
Authors :
Kristina Murata, MSN, FNP-BC - UCLA Medical Center; Aria Fallah, MD, MS - Assistant Professor, Neurosurgery, UCLA Medical Center; Hiroki Nariai, MD, MS, PhD - Assistant Professor, Pediatric Neurology, UCLA Medical Center; Shaun Hussain, MD - Assistant Professor, Pediatric Neurology, UCLA Medical Center; David Elashoff, PhD - Professor, Medicine, UCLA Medical Center; Jenny Brook, MS - Statistician, Medicine, UCLA Medical Center; Raman Sankar, MD, PhD - Professor & Chief, Pediatric Neurology and Neurology, UCLA Medical Center; Jerome Engel, MD, PhD - Professor, Neurology, Neurobiology and Psychiatry, & Biobehavioral Sciences, and Brain Research Institute, UCLA Medical Center; Joyce Wu, MD - Professor, Pediatrics, Epilepsy Center, Ann & Robert H. Lurie Children’s Hospital of Chicago
Rationale: Numerous observational studies suggest that interictal high-frequency oscillations (HFOs) on intracranial electroencephalogram (icEEG) represent a promising biomarker of epileptogenicity and may accurately delineate the epileptogenic zone. However, these findings have not yet been confirmed by a rigorous clinical trial. This is a superiority surgical clinical trial to evaluate the feasibility, safety, and efficacy of HFO-tailored resection in pediatric epilepsy surgery.
Methods: This is a prospective, double-blind, randomized controlled trial which included children with refractory focal epilepsy who underwent surgery with intra- or extra-operative icEEG with the UCLA Pediatric Epilepsy Program. Subjects and their neurologists were blinded to treatment group assignment. After stratification by etiology (congenital versus acquired) and type of monitoring (intra-operative versus extra-operative), subjects were randomized 1:1 to receive surgery tailored by HFO localization (250 to 500 Hz) and standard icEEG (experimental arm), versus by standard icEEG alone (control arm) (Figure 1). The primary outcome of this study is the comparative post-operative seizure freedom between the treatment and the control arms.
Results: Sixteen out of 17 eligible participants (median age 9.2 years, range 0.7-24 years) were consented and enrolled between December 2018 and May 2020. There were no significant differences in the baseline characteristics between the two groups (Table 1). There were 8 participants in each arm and 50% of the patients in each group achieved seizure freedom one-year post surgery. None of the patients in the treatment group received further resection based on the HFO data analysis. The trial ended early due to lack of resources. There was one perioperative unwitnessed fall which resulted in subdural hematoma requiring surgical evacuation. This incident was not an adverse event related to the trial.
Conclusions: This preliminary trial supports the feasibility and safety of incorporating HFO analysis into pediatric epilepsy surgery, as well as high parental support (94% consent rate) of such a trial. There may be a subset of patients that would benefit from analysis and resection based on HFOs. For this reason, it is important to recognize that HFO-based resections are not ready for routine clinical use and should only be offered in the context of a larger clinical trial. With identical seizure freedom rates in both the experimental and control groups, as well as zero patients receiving additional surgery based on HFO localization, these results suggest the need for a larger multi-center randomized controlled trial.
Funding: Please list any funding that was received in support of this abstract.: No funding was received in support of this abstract.
Surgery