Trial Outcomes & Findings for High Frequency Oscillation in Pediatric Epilepsy Surgery (NCT NCT03790280)
NCT ID: NCT03790280
Last Updated: 2023-09-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
1 year after surgery
Results posted on
2023-09-01
Participant Flow
Participant milestones
| Measure |
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.
|
Standard of Care
Surgery is tailored by standard ECoG alone (arm 2).
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Frequency Oscillation in Pediatric Epilepsy Surgery
Baseline characteristics by cohort
| Measure |
Standard of Care PLUS HFO
n=8 Participants
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.
|
Standard of Care
n=9 Participants
Surgery is tailored by standard ECoG alone (arm 2).
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Gender · Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Gender · Male
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 year after surgeryThe 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.
Outcome measures
| Measure |
Standard of Care PLUS HFO
n=8 Participants
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.
|
Standard of Care
n=9 Participants
Surgery is tailored by standard ECoG alone (arm 2).
|
|---|---|---|
|
Post-operative Seizure-free Rate
Seizure Free at 1 year post surgery
|
4 Participants
|
5 Participants
|
|
Post-operative Seizure-free Rate
Seizure Relapse at 1 year post surgery
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 year after surgeryNumber of participants experiencing surgical complications
Outcome measures
| Measure |
Standard of Care PLUS HFO
n=7 Participants
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.
|
Standard of Care
n=9 Participants
Surgery is tailored by standard ECoG alone (arm 2).
|
|---|---|---|
|
Post-operative Complication
|
0 Participants
|
0 Participants
|
Adverse Events
Standard of Care PLUS HFO
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care PLUS HFO
n=8 participants at risk
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.
|
Standard of Care
n=9 participants at risk
Surgery is tailored by standard ECoG alone (arm 2).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Subdural Hematoma
|
12.5%
1/8 • Number of events 1 • Adverse events were collected post-operatively for up to 1 year.
|
0.00%
0/9 • Adverse events were collected post-operatively for up to 1 year.
|
Additional Information
Angela Martinez, Research Manager
University of California, Los Angeles (UCLA)
Phone: 310-206-7630
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place