Evidence map›Paper›PMID 26399310›Full record

Trial reportTrials2015

High frequency oscillations in the intra-operative ECoG to guide epilepsy surgery ("The HFO Trial"): study protocol for a randomized controlled trial.

Maryse A van 't Klooster, Frans S S Leijten, Geertjan Huiskamp, Hanneke E Ronner, Johannes C Baayen, Peter C van Rijen, Martinus J C Eijkemans, Kees P J Braun, Maeike Zijlmans, HFO study group

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02207673 (Intra-operative Detection and Localisation of High Frequency Oscillations in the ECoG to Guide Epilepsy Surgery), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02207673 naunknown statusnot on this map

Intra-operative Detection and Localisation of High Frequency Oscillations in the ECoG to Guide Epilepsy Surgery

TypeinterventionalSponsorUMC UtrechtRan2014 to 2021Enrolled78ConditionsRefractory Localization-related EpilepsyArmsTailoring of the resection based on biomarker in aEcoG during epilepsy surgery
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. The role of high-frequency oscillations in epilepsy surgery planning.The Cochrane database of systematic reviews · 2017
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Maryse A van 't KloosterDepartment of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, PO Box 85500, 3504, Utrecht, GA, The Netherlands. m.a.vanhetklooster-2@umcutrecht.nl.
Frans S S LeijtenDepartment of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, PO Box 85500, 3504, Utrecht, GA, The Netherlands. F.S.S.Leijten@umcutrecht.nl.
Geertjan HuiskampDepartment of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, PO Box 85500, 3504, Utrecht, GA, The Netherlands. G.J.M.Huiskamp@umcutrecht.nl.
Hanneke E RonnerDepartment of Clinical Neurophysiology and Magnetoencephalography Center, VU University Medical Center, Amsterdam, The Netherlands. HE.Ronner@vumc.nl.
Johannes C BaayenNeurosurgical Center Amsterdam, VU University Medical Center Amsterdam, Amsterdam, The Netherlands. jc.baaijen@vumc.nl.
Peter C van RijenDepartment of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, PO Box 85500, 3504, Utrecht, GA, The Netherlands. P.v.Rijen@umcutrecht.nl.
Martinus J C EijkemansJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands. M.J.C.Eijkemans@umcutrecht.nl.
Kees P J BraunDepartment of Child Neurology, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands. K.Braun@umcutrecht.nl.
Maeike ZijlmansDepartment of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, PO Box 85500, 3504, Utrecht, GA, The Netherlands. G.J.M.Zijlmans@umcutrecht.nl.
HFO study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntra-operative electrocorticography, based on interictal spikes and spike patterns, is performed to optimize delineation of the epileptogenic tissue during epilepsy surgery. High frequency oscillations (HFOs, 80-500 Hz) have been identified as more precise biomarkers for epileptogenic tissue. The aim of the trial is to determine prospectively if ioECoG-tailored surgery using HFOs, instead of interictal spikes, is feasible and will lead to an equal or better seizure outcome. METHODS\

designWe present a single-blinded multi-center randomized controlled trial "The HFO Trial" including patients with refractory focal epilepsy of all ages who undergo surgery with intra-operative electrocorticography. Surgery is tailored by HFOs (arm 1) or interictal spikes (arm 2) in the intra-operative electrocorticography. Primary outcome is post-operative outcome after 1 year, dichotomized in seizure freedom (Engel 1A and 1B) versus seizure recurrence (Engel 1C-4). Secondary outcome measures are the volume of resected tissue, neurologic deficits, surgical duration and complications, cognition and quality of life. The trial has a non-inferiority design to test feasibility and at least equal performance in terms of surgical outcome. We aim to include 78 patients within 3 years including 1 year follow-up. Results are expected in 2018. DISCUSSION: This trial provides a transition from observational research towards clinical interventions using HFOs. We address methodological difficulties in designing this trial. We expect that the use of HFOs as a biomarker for tailoring will increase the success rate of epilepsy surgery while reducing resection volume. This may reduce neurological deficits and yield a better quality of life. Future technical developments, such as validated automatic online HFO identification, could, together with the attained clinical knowledge, lead to a new objective tailoring approach in epilepsy surgery.

trial registrationThis trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT02207673 (31 July 2014) and the Central Committee on Research Involving Human Subjects, The Netherlands #NL44257.041.13 (18 March 2014).

Indexed as

Brain WavesElectrocorticographyNeurosurgical ProceduresBrainClinical ProtocolsCognitionEpilepsyHumansIntraoperative Neurophysiological MonitoringNetherlandsPostoperative ComplicationsPredictive Value of TestsQuality of LifeRemission InductionResearch DesignSingle-Blind Method

Identifiers

PMID26399310
PMCPMC4581519

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.