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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02090569
Acronym
ULYS
Enrollment
3
Registered
2014-03-18
Start date
2014-04-07
Completion date
2017-10-31
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Drug-resistant Epilepsy

Keywords

Functional micro-Doppler Sonography, fmDS, dysplasia, epilepsy, neurosurgery, cerebral blood volume, echography, hemodynamics

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.

Interventions

DEVICEFunctional micro-Doppler Sonography (fmDS)

1. Craniotomy according to MRI images 2. Dura opening 3. Sulcal Localization using neuronavigation 4. Functional micro-Doppler Sonography including morphologic (Bmode) and functional measurement of the cerebral blood volume dynamics at high spatio-temporal resolution (100µm-20ms) using high-frequency (15MHz) ultrasound. At least 5 2-minute periods of spontaneous data will be recorded with a sampling rate for data acquisition of 15KHz and highpass filter of 10 to 70 Hz. 5. Exeresis of the dysplasic tissue 6. Control using fmDS before wound closure

Sponsors

Fondation de l'Avenir
CollaboratorOTHER
Fondation pour les Sciences du Cerveau
CollaboratorUNKNOWN
Association NEUROREFS
CollaboratorUNKNOWN
Centre Hospitalier St Anne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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.During the surgery at t0

Secondary

MeasureTime frame
Determine if the location of abnormal dysplasic tissue correlate with location of the epileptogenic zone in MRI-visible FCD12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026