Abstract
PurposeResective epilepsy surgery is a well-established, evidence-based treatment option in patients with drug-resistant focal epilepsy. A major predictive factor of good surgical outcome is visualization and delineation of a potential epileptogenic lesion by MRI. However, frequently, these lesions are subtle and may escape detection by conventional MRI (≤ 3 T). MethodsWe present the EpiUltraStudy protocol to address the hypothesis that application of ultra-high field (UHF) MRI increases the rate of detection of structural lesions and functional brain aberrances in patients with drug-resistant focal epilepsy who are candidates for resective epilepsy surgery. Additionally, therapeutic gain will be addressed, testing whether increased lesion detection and tailored resections result in higher rates of seizure freedom 1 year after epilepsy surgery. Sixty patients enroll the study according to the following inclusion criteria: aged ≥ 12 years, diagnosed with drug-resistant focal epilepsy with a suspected epileptogenic focus, negative conventional 3 T MRI during pre-surgical work-up.ResultsAll patients will be evaluated by 7 T MRI; ten patients will undergo an additional 9.4 T MRI exam. Images will be evaluated independently by two neuroradiologists and a neurologist or neurosurgeon. Clinical and UHF MRI will be discussed in the multidisciplinary epilepsy surgery conference. Demographic and epilepsy characteristics, along with postoperative seizure outcome and histopathological evaluation, will be recorded.ConclusionThis protocol was reviewed and approved by the local Institutional Review Board and complies with the Declaration of Helsinki and principles of Good Clinical Practice. Results will be submitted to international peer-reviewed journals and presented at international conferences.Trial registration numberwww.trialregister.nl: NTR7536.
Highlights
About 30–40% of patients with epilepsy are drug-resistant, with higher rates for children [1]
Samples of surgically treated patients will be examined by routine histopathological analysis and classified according to ILAE guidelines [20]
In case of resective epilepsy surgery, ultra-high field (UHF) magnetic resonance imaging (MRI)–based diagnosis will be compared to histopathological diagnosis
Summary
About 30–40% of patients with epilepsy are drug-resistant, with higher rates for children [1]. Resective epilepsy surgery is a well-established, evidence-based, treatment option for 10–50% of drug-resistant patients, depending on the underlying etiology [2,3,4]. One of the major predictive factors for good surgical outcome (i.e., seizure freedom) is the Extended author information available on the last page of the article detection of a potential epileptogenic lesion/zone on magnetic resonance imaging (MRI) [5,6,7]. 30% of adult and pediatric patients with focal epilepsy have no identifiable, potential epileptogenic lesion on MRI, “MRInegative” [8,9,10]. A considerable number of MRI-negative drug-resistant patients are not eligible for resective surgery, leading to continuation of disease burden and lower quality of life [9]. Recent developments in the field of non-invasive preoperative examinations, like high-density electroencephalography (EEG), EEG-functional MRI (fMRI), single photon emission computed tomography (SPECT), positron emission tomography (PET), magnetoencephalography (MEG),
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