Clinical Trial: High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: ULtrasound Imaging in Focal Cortical dYSplasia: a New Approach to Delineating the Dysplastic Cortex During Neurosurgery

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

Detailed Summary:

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 o
Sponsor: Centre Hospitalier St Anne

Current Primary Outcome: 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. [ Time Frame: During the surgery at t0 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Determine if the location of abnormal dysplasic tissue correlate with location of the epileptogenic zone in MRI-visible FCD [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: Centre Hospitalier St Anne

Dates:
Date Received: January 28, 2014
Date Started: April 2014
Date Completion: September 2017
Last Updated: March 2, 2016
Last Verified: March 2016