Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored Stereoelectroencephalography (ISDETSEEG)
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spectral Dynamic Imaging
Hybride electrode
Macro electrode
Sponsored by
About this trial
This is an interventional prevention trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Drug-resistant partial epilepsy justifying a SEEG exploration
- Intellectual capacities compatible with the award of cognitive tasks
Exclusion Criteria:
- Pregnant or lactating women
- Patient deprived of liberty by a judicial or administrative
- Major patient subject to a measure of legal protection
Sites / Locations
- University Hospital Grenoble
- University Hospital Lyon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evaluation of cognitive functions by Spectral Dynamic Imaging
Arm Description
Evaluation of cognitive functions by SDI will be conducted during the exploration SEEG (which usually lasts from 1 to 3 weeks), and started a few days after implantation of intracranial electrodes
Outcomes
Primary Outcome Measures
Functional brain mapping procedure using the EEG signal intracranial to minimize the risk of cognitive deficits associated with resection of the epileptogenic zone.
Secondary Outcome Measures
Full Information
NCT ID
NCT02869698
First Posted
August 4, 2016
Last Updated
October 25, 2017
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT02869698
Brief Title
Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored Stereoelectroencephalography
Acronym
ISDETSEEG
Official Title
Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective research aims to develop the use of Spectral Imaging in addition Dynamics of cortical electrical stimulation to identify major anatomical and functional networks in epileptic patients candidates for surgery and explored by stereoencephalography, to minimize risk of post-surgical cognitive deficits.
Detailed Description
Cognitive deficits after epilepsy surgery are poorly known particularly because the tools used to evaluate them. In addition, the prevention of certain postoperative deficits, is extremely difficult because of the lack of robust markers to anticipate. The various examinations conventionally used for this purpose (neuropsychological testing, functional MRI and cortical stimulation) does indeed provide insufficient information or difficult to interpret, so the development of improved methods appears as an imperative in the field of the epilepsy surgery.
SID appears as such particularly adapted to the case of epileptic patients explored SEEG to provide individualized cognitive map millimeter thereof without requiring, for additional invasive act, or risk of inducing unintended crisis. In practice, this clinical research project should lead to the definition of several simple cognitive tasks which, together, could be achieved by each volunteer patient in two or three hours, and then analyzed in a similar time to provide fast, even the patient is still explored SEEG and even before cortical electrical stimulation, a list of brain regions involved in most major cognitive functions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evaluation of cognitive functions by Spectral Dynamic Imaging
Arm Type
Experimental
Arm Description
Evaluation of cognitive functions by SDI will be conducted during the exploration SEEG (which usually lasts from 1 to 3 weeks), and started a few days after implantation of intracranial electrodes
Intervention Type
Procedure
Intervention Name(s)
Spectral Dynamic Imaging
Intervention Type
Device
Intervention Name(s)
Hybride electrode
Other Intervention Name(s)
AdTech Medical Instrument Corporation
Intervention Type
Device
Intervention Name(s)
Macro electrode
Other Intervention Name(s)
DIXI Microtechniques
Primary Outcome Measure Information:
Title
Functional brain mapping procedure using the EEG signal intracranial to minimize the risk of cognitive deficits associated with resection of the epileptogenic zone.
Time Frame
3 weeks
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:
Drug-resistant partial epilepsy justifying a SEEG exploration
Intellectual capacities compatible with the award of cognitive tasks
Exclusion Criteria:
Pregnant or lactating women
Patient deprived of liberty by a judicial or administrative
Major patient subject to a measure of legal protection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe KAHANE
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
Country
France
Facility Name
University Hospital Lyon
City
Lyon
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored Stereoelectroencephalography
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