Multicenter Comparison of Interictal HFO as a Predictor of Seizure Freedom

Epilepsy Intractable Clinical Trial

— multiHFO  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05332990
• Other study ID #: multiHFO
• Status: Enrolling by invitation
• Start date: May 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older
• Eligibility: Data as provided from the participating center

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy Intractable
• Seizures

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Neurosurgery	Zurich	ZH

Sponsors (10)

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

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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 — View Citation

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/brainco — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seizure freedom	ILAE grade 1	2 years after surgery
Primary	seizure recurrence	ILAE grade 2-6	within 2 years after surgery

External Links

•   HFO analysis: publications, algorithms and data