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

January 23, 2018 updated by: Centre Hospitalier St Anne

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

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75014
        • Centre Hospitalier St Anne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Functional micro-Doppler sonography
  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
Other Names:
  • DFC2 removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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.
Time Frame: During the surgery at t0
During the surgery at t0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bertrand DEVAUX, MD, PhD, Centre Hospitalier St Anne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 7, 2014

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (ESTIMATE)

March 18, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

October 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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