Status:
UNKNOWN
A New Method for Delineation of Epileptic Brian Tissue During Epilepsy Surgery (The HFO Study)
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Rudolf Magnus Institute - University of Utrecht
Conditions:
Refractory Localization-related Epilepsy
Eligibility:
All Genders
Phase:
NA
Brief Summary
Epilepsy occurs in 0.5-0.7% of the population, of which 25% are children. 30% Of patients with focal epilepsy do not respond well to medication and half of them are eligible for epilepsy surgery. In r...
Eligibility Criteria
Inclusion
- Patients of all ages with:
- Refractory Focal Epilepsy; at least ≥2 experienced seizures in the past 24 months, in spite of 2 or more different anti-epileptic drugs tried.
- Planned neurosurgery with aECoG, with the goal of tailoring the resection.
- Command of Dutch language of the patient/parents/legal representatives and capability of completing the questionnaires (by email or phone).
Exclusion
- Patients who underwent chronic ECoG monitoring preceding epilepsy surgery (grids). This is a biased population, since the results of the extensive pre-surgical work-up as well as the results of the cECoG monitoring period are included in the final decision making regarding the resection, and a precise seizure onset zone as well as spike and HFO area are known.
- Patients with an occipital focus undergoing aECoG. Currently, it is not possible to discriminate between pathological or physiological occipital HFOs, and thus unsafe to perform HFO guided resections in patients with a presumed occipital focus.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT02207673
Start Date
November 1 2014
End Date
June 1 2021
Last Update
November 4 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
VU University medical center
Amsterdam, Netherlands, 1081 HV
2
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CG