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A New Method for Delineation of Epileptic Brian Tissue During Epilepsy Surgery (The HFO Study)

NCT ID: NCT02207673

Last Updated: 2020-11-04

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2021-06-30

Brief Summary

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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 recent years, the importance of early epilepsy surgery has been stressed, as successful surgery may lead seizure and medication freedom and improved social and cognitive development, especially in children. The current success rate of epilepsy surgery is around 65%; During surgery intracranial electrocorticography (acute ECoG, aECoG) is recorded in some medical centers. The presence of epileptiform brian activity, spikes, identified by clinical neurophysiologists, is used to guide the neurosurgeon in the extent of the brain tissue that needs to be resected. Spikes are considered markers of the presence of epilepsy. High Frequency Oscillations (HFOs, \>80-500Hz) in the ECoG have recently been identified as a new biomarker for epileptogenic tissue. Retrospective research shows that their local presence strongly relates to the seizure onset, and removal of tissue with HFOs could predict a better surgical outcome. The area showing HFOs usually overlaps with, but is smaller than the area with spikes, and HFOs do not tend to propagate to distant sites as spikes do. The identification of HFOs is more objective than of spikes and automatic detection software exists.

A pilot study is performed to test the hypothesis : The intra-operative use of HFOs to delineate the epileptogenic cortex does not yield significantly worse outcome in seizure freedom than the current method based on spikes.

Study design is a single blinded multi-center randomized controlled trial. In two Dutch centers, the VU medical center ( Amsterdam) and University Medical Center Utrecht.

The study population (sample size 78) consists of patients of all ages with refractory epilepsy undergoing epilepsy surgery with aECoG to guide the extent of the resection.

Eligible patients are randomised, after informed consent, into group 1 (HFOs) in whom a resection guided by HFOs in the aECoG (new), or into group 2 (spikes) in whom a resection is guided by epileptiform spikes in the aECoG (current standard). Ictiform spike patterns will always be resected.

Main study endpoint is outcome after epilepsy surgery after 1 year of follow-up dichotomized in total seizure freedom (Engel Ia\&b) vs. seizure recurrence (Engel Ic-IV).

Detailed Description

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Conditions

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Refractory Localization-related Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Spikes as biomarker

In arm " spikes" the resection of epileptogenic tissue is guided by epileptiform spikes in the aECoG (current standard). (Independent of the randomisation ictiform spike patterns will always be resected.)

Group Type ACTIVE_COMPARATOR

Tailoring of the resection based on biomarker in aEcoG during epilepsy surgery

Intervention Type PROCEDURE

HFOs as biomarker

In arm "HFOs" resection of epileptogenic tissue is guided by HFOs in the aECoG (new). (Independent of the randomisation ictiform spike patterns will always be resected.)

Group Type EXPERIMENTAL

Tailoring of the resection based on biomarker in aEcoG during epilepsy surgery

Intervention Type PROCEDURE

Interventions

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Tailoring of the resection based on biomarker in aEcoG during epilepsy surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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 Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rudolf Magnus Institute - University of Utrecht

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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G.J.M. Zijlmans

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maeike Zijlmans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Utrecht, the Netherlands

Maryse van 't Klooster, MSc.

Role: STUDY_DIRECTOR

University Medical Center Utrecht, the Netherlands

Locations

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VU University medical center

Amsterdam, , Netherlands

Site Status

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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van 't Klooster MA, Leijten FS, Huiskamp G, Ronner HE, Baayen JC, van Rijen PC, Eijkemans MJ, Braun KP, Zijlmans M; HFO study group. High frequency oscillations in the intra-operative ECoG to guide epilepsy surgery ("The HFO Trial"): study protocol for a randomized controlled trial. Trials. 2015 Sep 23;16:422. doi: 10.1186/s13063-015-0932-6.

Reference Type RESULT
PMID: 26399310 (View on PubMed)

Zweiphenning W, Klooster MAV', van Klink NEC, Leijten FSS, Ferrier CH, Gebbink T, Huiskamp G, van Zandvoort MJE, van Schooneveld MMJ, Bourez M, Goemans S, Straumann S, van Rijen PC, Gosselaar PH, van Eijsden P, Otte WM, van Diessen E, Braun KPJ, Zijlmans M; HFO study group. Intraoperative electrocorticography using high-frequency oscillations or spikes to tailor epilepsy surgery in the Netherlands (the HFO trial): a randomised, single-blind, adaptive non-inferiority trial. Lancet Neurol. 2022 Nov;21(11):982-993. doi: 10.1016/S1474-4422(22)00311-8.

Reference Type DERIVED
PMID: 36270309 (View on PubMed)

Related Links

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http://research.umcutrechthersencentrum.nl/whos-who/bio/maeike-zijlmans/

Related info

Other Identifiers

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13-389

Identifier Type: OTHER

Identifier Source: secondary_id

2012-4

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL44527.041.13

Identifier Type: -

Identifier Source: org_study_id