Epilepsy Surgery, High Frequency Oscillation, Pediatric Epilepsy
Conditions
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.
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.
Interventions
DIAGNOSTIC_TESTHFO 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.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
Intervention model description
Randomization into standard arm and the treatment arm in a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
0 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Seizure-free Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Complication | 1 year after surgery | Number of participants experiencing surgical complications |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
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. | 8 |
| Standard of Care Surgery is tailored by standard ECoG alone (arm 2). | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | Standard of Care PLUS HFO | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Gender Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Gender Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 1 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
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.
Time frame: 1 year after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care PLUS HFO | Post-operative Seizure-free Rate | Seizure Free at 1 year post surgery | 4 Participants |
| Standard of Care PLUS HFO | Post-operative Seizure-free Rate | Seizure Relapse at 1 year post surgery | 4 Participants |
| Standard of Care | Post-operative Seizure-free Rate | Seizure Relapse at 1 year post surgery | 4 Participants |
| Standard of Care | Post-operative Seizure-free Rate | Seizure Free at 1 year post surgery | 5 Participants |
Secondary
Post-operative Complication
Number of participants experiencing surgical complications
Time frame: 1 year after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care PLUS HFO | Post-operative Complication | 0 Participants |
| Standard of Care | Post-operative Complication | 0 Participants |