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Multicenter Comparison of Interictal HFO as a Predictor of Seizure Freedom

Multicenter Comparison of Interictal High Frequency Oscillations as a Predictor of Seizure Freedom

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05332990
Acronym
multiHFO
Enrollment
300
Registered
2022-04-18
Start date
2022-05-01
Completion date
2024-05-01
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy Intractable

Brief summary

In drug-resistant focal epilepsy, interictal high frequency oscillations (HFO) recorded from intracranial EEG (iEEG) may provide clinical information for delineating epileptogenic brain tissue. The iEEG electrode contacts that contain HFO are hypothesized to delineate the epileptogenic zone; their resection should then lead to postsurgical seizure freedom. We test whether our prospective definition of clinically relevant HFO is in agreement with postsurgical seizure outcome. The algorithm is fully automated and is equally applied to all datasets. The aim is to assess the reliability of the proposed detector and analysis approach.

Detailed description

We use an automated data-independent prospective definition of clinically relevant HFO that has been validated in data from two independent epilepsy centers. In this study, we combine retrospectively collected datasets from 9 independent epilepsy centers. The analysis is blinded to clinical outcome. We use iEEG recordings during NREM sleep with a minimum of 12 epochs of 5 minutes of NREM sleep. We automatically detect HFO in the ripple (80-250 Hz) and in the fast ripple (250-500 Hz) band. There is no manual rejection of events in this fully automated algorithm. The type of HFO that we consider clinically relevant is defined as the simultaneous occurrence of a fast-ripple and a ripple. We calculate the temporal consistency of each patient's HFO rates over several data epochs within and between nights. Patients with temporal consistency \< 50% are excluded from further analysis. We determine whether all electrode contacts with high HFO rate are included in the resection volume and whether seizure freedom (ILAE 1) was achieved at ≥2 y follow-up. Applying a previously validated algorithm to a large cohort from several independent epilepsy centers may advance the clinical relevance and the generalizability of HFO analysis as essential next step for use of HFO in clinical practice.

Interventions

DIAGNOSTIC_TESTHFO analysis

We use an automated data-independent prospective definition of clinically relevant HFO that has been validated in data from two independent epilepsy centers.

Sponsors

McGill University
CollaboratorOTHER
University of Michigan
CollaboratorOTHER
University of Calgary
CollaboratorOTHER
Cook Children's Health Care System
CollaboratorOTHER
St. Anne's University Hospital Brno, Czech Republic
CollaboratorOTHER
Mayo Clinic
CollaboratorOTHER
Thomas Jefferson University
CollaboratorOTHER
UMC Utrecht
CollaboratorOTHER
Schweizerisches Epilepsie Zentrum
CollaboratorUNKNOWN
University of Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Data as provided from the participating center

Design outcomes

Primary

MeasureTime frameDescription
seizure freedom2 years after surgeryILAE grade 1
seizure recurrencewithin 2 years after surgeryILAE grade 2-6

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026