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Multicenter Comparison of Interictal HFO as a Predictor of Seizure Freedom

NCT ID: NCT05332990

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-05-01

Brief Summary

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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

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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.

Conditions

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Epilepsy Intractable

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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HFO analysis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Data as provided from the participating center
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role collaborator

Cook Children's Health Care System

OTHER

Sponsor Role collaborator

St. Anne's University Hospital Brno, Czech Republic

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role collaborator

Schweizerisches Epilepsie Zentrum

UNKNOWN

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Zurich, Neurosurgery

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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Dimakopoulos V, Gotman J, Stacey W, von Ellenrieder N, Jacobs J, Papadelis C, Cimbalnik J, Worrell G, Sperling MR, Zijlmans M, Imbach L, Frauscher B, Sarnthein J. Protocol for multicentre comparison of interictal high-frequency oscillations as a predictor of seizure freedom. Brain Commun. 2022 Jun 9;4(3):fcac151. doi: 10.1093/braincomms/fcac151. eCollection 2022.

Reference Type RESULT
PMID: 35770134 (View on PubMed)

Dimakopoulos V, Megevand P, Boran E, Momjian S, Seeck M, Vulliemoz S, Sarnthein J. Blinded study: prospectively defined high-frequency oscillations predict seizure outcome in individual patients. Brain Commun. 2021 Sep 2;3(3):fcab209. doi: 10.1093/braincomms/fcab209. eCollection 2021.

Reference Type RESULT
PMID: 34541534 (View on PubMed)

Fedele T, Burnos S, Boran E, Krayenbuhl N, Hilfiker P, Grunwald T, Sarnthein J. Resection of high frequency oscillations predicts seizure outcome in the individual patient. Sci Rep. 2017 Oct 23;7(1):13836. doi: 10.1038/s41598-017-13064-1.

Reference Type RESULT
PMID: 29062105 (View on PubMed)

Dimakopoulos V, Gotman J, Klimes P, von Ellenrieder N, Tan SB, Smith G, Gliske SV, Maltseva M, Manalo MK, Pail M, Brazdil M, van Blooijs D, van 't Klooster MA, Johnson S, Laboy S, Ledergerber D, Imbach L, Papadelis C, Sperling MR, Zijlmans M, Cimbalnik J, Jacobs J, Stacey WC, Frauscher B, Sarnthein J. Multicentre analysis of seizure outcome predicted by removal of high-frequency oscillations. Brain. 2025 May 13;148(5):1769-1777. doi: 10.1093/brain/awae361.

Reference Type DERIVED
PMID: 39530262 (View on PubMed)

Related Links

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https://hfozuri.ch/

HFO analysis: publications, algorithms and data

Other Identifiers

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multiHFO

Identifier Type: -

Identifier Source: org_study_id