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

Primary Purpose

Partial Drug-resistant Epilepsy

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional micro-Doppler Sonography (fmDS)
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Drug-resistant Epilepsy focused on measuring Functional micro-Doppler Sonography, fmDS, dysplasia, epilepsy, neurosurgery, cerebral blood volume, echography, hemodynamics

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier St Anne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Functional micro-Doppler sonography

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Determine if the location of abnormal dysplasic tissue correlate with location of the epileptogenic zone in MRI-visible FCD

Full Information

First Posted
January 28, 2014
Last Updated
January 23, 2018
Sponsor
Centre Hospitalier St Anne
Collaborators
Fondation de l'Avenir, Fondation pour les Sciences du Cerveau, Association NEUROREFS
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1. Study Identification

Unique Protocol Identification Number
NCT02090569
Brief Title
High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery
Acronym
ULYS
Official Title
ULtrasound Imaging in Focal Cortical dYSplasia: a New Approach to Delineating the Dysplastic Cortex During Neurosurgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
recommandation of the Data Safety monitoring Board
Study Start Date
April 7, 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne
Collaborators
Fondation de l'Avenir, Fondation pour les Sciences du Cerveau, Association NEUROREFS

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Drug-resistant Epilepsy
Keywords
Functional micro-Doppler Sonography, fmDS, dysplasia, epilepsy, neurosurgery, cerebral blood volume, echography, hemodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional micro-Doppler sonography
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Functional micro-Doppler Sonography (fmDS)
Other Intervention Name(s)
DFC2 removal
Intervention Description
Craniotomy according to MRI images Dura opening Sulcal Localization using neuronavigation 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. Exeresis of the dysplasic tissue Control using fmDS before wound closure
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Determine if the location of abnormal dysplasic tissue correlate with location of the epileptogenic zone in MRI-visible FCD
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand DEVAUX, MD, PhD
Organizational Affiliation
Centre Hospitalier St Anne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier St Anne
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24237393
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.
Results Reference
result
PubMed Identifier
22555587
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.
Results Reference
result

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

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