NCT05332990

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

April 10, 2022

Last Update Submit

November 30, 2023

Conditions

Epilepsy Intractable

Outcome Measures

Primary Outcomes (2)

  • seizure freedom

    ILAE grade 1

    2 years after surgery

  • seizure recurrence

    ILAE grade 2-6

    within 2 years after surgery

Interventions

HFO analysisDIAGNOSTIC_TEST

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We include patients with drug-resistant focal epilepsy of all ages who 1) underwent invasive EEG recordings with subdural and/or depth electrodes as part of their pre-surgical evaluation 4, 2) underwent epilepsy surgery aiming at seizure freedom after resection of a single focus, and 3) and the postsurgical seizure outcome was determined by follow-up visits at ≥ 2 y 32. According to the International League Against Epilepsy (ILAE) Classification 3 we classify outcome into seizure freedom (ILAE 1) or recurrent seizures (ILAE 2-6). Outcome data that are assessed with the Engel scale are mapped to ILAE 1 or ILAE 2-6 respectively.

Data as provided from the participating center

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Neurosurgery

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 35770134RESULT

  • 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.

    PMID: 34541534RESULT

  • 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.

    PMID: 29062105RESULT

  • 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.

    PMID: 39530262DERIVED

Related Links

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2022

First Posted

April 18, 2022

Study Start

May 1, 2022

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

December 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)