Clinical trial NCT02090569: High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery
Official title: ULtrasound Imaging in Focal Cortical dYSplasia: a New Approach to Delineating the Dysplastic Cortex During Neurosurgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Partial Drug-resistant Epilepsy
Keywords: Functional micro-Doppler Sonography, fmDS, dysplasia, epilepsy, neurosurgery, cerebral blood volume, echography, hemodynamics
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
name: Fondation pour les Sciences du Cerveau
name: Association NEUROREFS
First posted: 2014-03-18
Enrollment: 3
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery (ULYS)

Detailed description: Three decades since its comprehensive description (Taylor et al., 1971), focal cortical dysplasia (FCD) remains an enigmatic condition. FCD may cause severe refractory epilepsy that can be directly life threatening. Preoperative neuroimaging usually includes high-resolution MR imaging, which can reveal only 60 to 80% of cortical abnormalities in patients with FCD. When antiepileptic drugs fail to bring complete seizure freedom in FCD patients, surgical resection of the FCD is inevitable. Many patients, especially those with normal MR imaging results, undergo additional diagnostic procedures. Scalp EEG is frequently used and was one of the more important modalities during early surgical series. Approximately one half to two thirds of patients with abnormal EEG findings have a regional ictal abnormality. In some cases, intracranial electrophysiological recordings, most commonly with grid arrays, are used. Chronic recording allows identification of eloquent cortex areas, in addition to defining the epileptogenic region. The "eloquent brain" refers to the parts of the brain that allows the interaction with and the process of surrounding environment, via the senses, motion, language, memory and the purposeful use of tools. Nevertheless, all these techniques are either invasive or have a spatiotemporal resolution too poor to identify precisely the epileptic lesion deep in the brain. Hence, large resection of lesion areas, such as lobectomies and even hemispherectomies, are performed with a high risk of side effects including aphasia, partial face paralysis and hemiplegia depending on the localization of the lesion.

Navigable three-dimensional (3D)-MRI (based on Neuronavigation system) is currently used at the Sainte Anne hospital for planning and guiding during resection but neurosurgeons often complains about poor resolution and non-real-time imaging. While the use of surgical navigation has been an important advance in brain surgery, its utility is limited by the phenomenon known as brain shift. Whenever the brain is exposed, cerebral spinal fluid (CSF) is lost. Additionally, after the start of resectioning, the position of the surgical field can shift by centimeters, compared to the pre-surgery position. Brain shift makes it potentially hazardous to rely on preoperative images to determine the location of residual tumors. The only way to deal with brain shift and maintain accurate neuronavigation is with intraoperative imaging to enhance resection of the pathologic tissue in FCD.

Previously, the investigators demonstrated the feasibility of their approach by monitoring the hemodynamic responses during drug-induced epileptic seizures in preclinical models using functional micro-Doppler Sonography (fmDS).

The investigators are now developing this new tool combining a navigable three-dimensional (3D)-ultrasound interface to correct in real-time the brain shift (B-mode) with the near-real-time identification with unprecedented resolution of the dysplasia foci based on the specific hemodynamic signature of abnormal neurons.

Eligibility criteria: Inclusion Criteria:

* Age between 6 and 65 years
* Patient follow-up in the Neurosurgery department for a partial drug-resistant epilepsy
* Etiological diagnosis certain or likely of DCF2
* Operating indication
* consent (or agreement of the legal representative) to participate in the study

Exclusion Criteria:

* Etiological diagnosis other than a DCF2
* Refusal of consent
* No health insurance

Primary outcomes:
measure: Precise delineating of the dysplasic tissue in the white matter of patient with MRI-visible FCD using a 2D voxel-by-voxel analysis based on ultrasound B-Mode and micro-Doppler mode.
timeFrame: During the surgery at t0
Secondary outcomes:
measure: Determine if the location of abnormal dysplasic tissue correlate with location of the epileptogenic zone in MRI-visible FCD
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier St Anne
Study officials:
affiliation: Centre Hospitalier St Anne
name: Bertrand DEVAUX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mellerio C, Labeyrie MA, Chassoux F, Roca P, Alami O, Plat M, Naggara O, Devaux B, Meder JF, Oppenheim C. 3T MRI improves the detection of transmantle sign in type 2 focal cortical dysplasia. Epilepsia. 2014 Jan;55(1):117-22. doi: 10.1111/epi.12464. Epub 2013 Nov 15.
citation: Mellerio C, Labeyrie MA, Chassoux F, Daumas-Duport C, Landre E, Turak B, Roux FX, Meder JF, Devaux B, Oppenheim C. Optimizing MR imaging detection of type 2 focal cortical dysplasia: best criteria for clinical practice. AJNR Am J Neuroradiol. 2012 Nov;33(10):1932-8. doi: 10.3174/ajnr.A3081. Epub 2012 May 3.