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

van 't Klooster MA, Leijten FS, Huiskamp G, Ronner HE, Baayen JC, van Rijen PC, Eijkemans MJ, Braun KP, Zijlmans M, HFO study gro - Trials (2015)

Bottom Line: Secondary outcome measures are the volume of resected tissue, neurologic deficits, surgical duration and complications, cognition and quality of life.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.

View Article: PubMed Central - PubMed

Affiliation: Department 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.

ABSTRACT

Background: Intra-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\

Design: We 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 registration: This 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).

No MeSH data available.


Related in: MedlinePlus

Timeline of the study procedures. On the day prior to surgery, the patient signs the informed consent form and subsequently the baseline questionnaire and neurological examination (by means of National Institutes of Health Stroke Scale (NIHSS)) are completed and the patient is enrolled in the study by randomization. Note that the follow-up questionnaire collects information about (preliminary) outcome, anti-epileptic drug use, quality of life and occurrence of (serious) adverse events. Additional information is collected from routine clinical tests that are performed during the pre-surgical and post-surgical period
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Fig1: Timeline of the study procedures. On the day prior to surgery, the patient signs the informed consent form and subsequently the baseline questionnaire and neurological examination (by means of National Institutes of Health Stroke Scale (NIHSS)) are completed and the patient is enrolled in the study by randomization. Note that the follow-up questionnaire collects information about (preliminary) outcome, anti-epileptic drug use, quality of life and occurrence of (serious) adverse events. Additional information is collected from routine clinical tests that are performed during the pre-surgical and post-surgical period

Mentions: Data collection, management and storage is done in open source clinical trial software OpenClinica (OpenClinica, LLC, Waltham, MA, USA; www.openclinica.com), managed by the IT division of the Neurology and Neurosurgery Department of the UMC Utrecht. FigureĀ 1 shows the timeline of the study procedures.Fig. 1


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

van 't Klooster MA, Leijten FS, Huiskamp G, Ronner HE, Baayen JC, van Rijen PC, Eijkemans MJ, Braun KP, Zijlmans M, HFO study gro - Trials (2015)

Timeline of the study procedures. On the day prior to surgery, the patient signs the informed consent form and subsequently the baseline questionnaire and neurological examination (by means of National Institutes of Health Stroke Scale (NIHSS)) are completed and the patient is enrolled in the study by randomization. Note that the follow-up questionnaire collects information about (preliminary) outcome, anti-epileptic drug use, quality of life and occurrence of (serious) adverse events. Additional information is collected from routine clinical tests that are performed during the pre-surgical and post-surgical period
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4581519&req=5

Fig1: Timeline of the study procedures. On the day prior to surgery, the patient signs the informed consent form and subsequently the baseline questionnaire and neurological examination (by means of National Institutes of Health Stroke Scale (NIHSS)) are completed and the patient is enrolled in the study by randomization. Note that the follow-up questionnaire collects information about (preliminary) outcome, anti-epileptic drug use, quality of life and occurrence of (serious) adverse events. Additional information is collected from routine clinical tests that are performed during the pre-surgical and post-surgical period
Mentions: Data collection, management and storage is done in open source clinical trial software OpenClinica (OpenClinica, LLC, Waltham, MA, USA; www.openclinica.com), managed by the IT division of the Neurology and Neurosurgery Department of the UMC Utrecht. FigureĀ 1 shows the timeline of the study procedures.Fig. 1

Bottom Line: Secondary outcome measures are the volume of resected tissue, neurologic deficits, surgical duration and complications, cognition and quality of life.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.

View Article: PubMed Central - PubMed

Affiliation: Department 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.

ABSTRACT

Background: Intra-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\

Design: We 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 registration: This 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).

No MeSH data available.


Related in: MedlinePlus