Evaluation of the Risk of Cognitive Deficit After Surgery of Epilepsy by Dynamic Spectral Imaging (ISD) of the Cognitive Functions in Patients Explored in StereoElectroEncephaloGraphy (SEEG) (ISD SEEG)
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dynamic Spectral Imaging (ISD)
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy focused on measuring SEEG, ISD, cognitive disorder, epilepsy surgery
Eligibility Criteria
Inclusion Criteria:
- patient adult (18-65 y/o) without legal protection measures
- Patient with a drug-resistant focal epilepsy
- Patient with a SEEG exploration as part of pre-surgical assessment of epilepsy
- patient with a consent form signed
- Intellectual capacities compatible with cognitive tasks and the signing of informed consent
- Affiliation to the social security
Exclusion Criteria:
- Pregnant women: this is already a contraindication to the realization of a SEEG study
- Subjects under 18 years of age or over 65 years of age
- Patient not suffering from EFPR, or not scheduled for SEEG
- Intellectual capacities incompatible with the cognitive tasks and / or the signature of a consent
Sites / Locations
- Hospices Civils de LyonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dynamic Spectral Imaging (ISD)
Arm Description
Evaluation of cognitive functions by ISD
Outcomes
Primary Outcome Measures
predictive character of the cortical gamma oscillatory pattern associated with a specific cognitive task on the risk of occurrence of a cognitive disorder after epilepsy surgery
Relation between the presence in the epileptogenic zone of a gamma activation in at least 1 of the cognitive tasks performed during the ISD and the occurrence of a postoperative neuropsychological deficit (Wilcoxon test)
Secondary Outcome Measures
database on the dynamics of large cerebral networks underlying the main cognitive functions
Comparison of mapping of pre-surgical gamma activity with preoperative neu-ropsychological evaluation
spatio-temporal organization of these networks with that predicted by fMRI
Pre-surgical comparison of the performances for the functional cartography of gamma activity performed during SEEG, fMRI and cortical stimulation at preoperative assessment.
effect of intracerebral electrical stimulations
Pre-surgical comparison of the performances for the functional cartography of gamma activity performed during SEEG, fMRI and cortical stimulation at preoperative assessment.
macro-electrophysiological recordings
The relation between the presence in the epileptogenic zone of an activation in the other frequency bands (theta, alpha, beta) in at least 1 of the cognitive tasks performed during the ISD and the occurrence of a post neuropsychological deficit
micro-electrophysiological recordings
The relation between the presence in the epileptogenic zone of an activation in the other frequency bands (theta, alpha, beta) in at least 1 of the cognitive tasks performed during the ISD and the occurrence of a post neuropsychological deficit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03094312
Brief Title
Evaluation of the Risk of Cognitive Deficit After Surgery of Epilepsy by Dynamic Spectral Imaging (ISD) of the Cognitive Functions in Patients Explored in StereoElectroEncephaloGraphy (SEEG)
Acronym
ISD SEEG
Official Title
Evaluation of the Risk of Cognitive Deficit After Surgery of Epilepsy by Dynamic Spectral Imaging (ISD) of the Cognitive Functions in Patients Explored in StereoElectroEncephaloGraphy (SEEG)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2017 (Actual)
Primary Completion Date
January 23, 2027 (Anticipated)
Study Completion Date
January 23, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Epilepsy affects between 0.5 and 0.7% of the European population. Despite the availability of numerous drug treatments, one third of patients still have seizures, which are associated with significant cognitive and social complications and excess mortality. In these patients, surgical treatment to remove the epileptogenic zone (EZ), the region of the brain responsible for seizures, is the only approach that can allow control of the disease. However, before investigating this surgery, investigations have to answer two questions: (i) what is the location and extension of the EZ and (ii) what functional risks, both motor and cognitive, would represent the resection of this Cortical region? As it is a functional surgery, it is in fact inconceivable that the surgery will result in an over-handicap. For these reasons, all candidates for surgery benefit from a complete assessment including imaging examinations, a neuropsychological assessment and a long-term video-EEG recording to record seizures. Nevertheless, in some patients, this assessment does not give us a formal answer. In these subjects, it is then necessary to carry out a second step, consisting of an invasive exploration by implantation of intracerebral electrodes during a stereoencephalography (SEEG). Due to its temporal and spatial resolution, the SEEG allows, besides the precise determination of the EZ, to carry out a functional mapping of the cortical regions likely to be included in cortectomy. Conventionally, this mapping is carried out on the basis of the cortical electrical stimulations applied to the implanted electrodes. If this approach is very robust for exploring primary functions such as motor skills or language, it cannot be used to evaluate more complex cognitive tasks such as face recognition or attention Effective cognitive treatment on a daily basis. This has led to the development in recent years, in Lyon and Grenoble, of a complementary approach to cerebral stimulation: dynamic spectral imaging (ISD). Numerous experimental paradigms have demonstrated that the realization of a cognitive task associates with the generation within the cortical regions involved in its treatment of a particular cortical activity. This activity is characterized by oscillations of the cortical rhythm in high frequencies (> 30 Hz), called gamma activities. The ISD thus consists in mapping this gamma activity during various cognitive tasks, thus making it possible to study more widely the complexity of the cognitive functions. Correlations between gamma activity and cognitive tasks have so far been exclusively performed in the non-epileptic cortex explored at the periphery of the EA during SEEG. Nevertheless, the cortical oscillatory pattern study associated with a specific cognitive task within the EZ could better anticipate complex cognitive deficits that could be generated by the resection of a cortical region.
The main objective of this project is to establish the predictive character of the gamma cortical oscillatory pattern associated with a specific cognitive task on the risk of occurrence of a cognitive disorder after surgery of epilepsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
SEEG, ISD, cognitive disorder, epilepsy surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dynamic Spectral Imaging (ISD)
Arm Type
Experimental
Arm Description
Evaluation of cognitive functions by ISD
Intervention Type
Procedure
Intervention Name(s)
Dynamic Spectral Imaging (ISD)
Intervention Description
cerebral stimulation: dynamic spectral imaging (ISD)
Primary Outcome Measure Information:
Title
predictive character of the cortical gamma oscillatory pattern associated with a specific cognitive task on the risk of occurrence of a cognitive disorder after epilepsy surgery
Description
Relation between the presence in the epileptogenic zone of a gamma activation in at least 1 of the cognitive tasks performed during the ISD and the occurrence of a postoperative neuropsychological deficit (Wilcoxon test)
Time Frame
12 months post-surgery compare to preoperative assessment (SEEG)
Secondary Outcome Measure Information:
Title
database on the dynamics of large cerebral networks underlying the main cognitive functions
Description
Comparison of mapping of pre-surgical gamma activity with preoperative neu-ropsychological evaluation
Time Frame
pre-surgical assessment (SEEG)
Title
spatio-temporal organization of these networks with that predicted by fMRI
Description
Pre-surgical comparison of the performances for the functional cartography of gamma activity performed during SEEG, fMRI and cortical stimulation at preoperative assessment.
Time Frame
preoperative assessment (SEEG, fMRI and cortical stimulations)
Title
effect of intracerebral electrical stimulations
Description
Pre-surgical comparison of the performances for the functional cartography of gamma activity performed during SEEG, fMRI and cortical stimulation at preoperative assessment.
Time Frame
preoperative assessment (SEEG, fMRI and cortical stimulations)
Title
macro-electrophysiological recordings
Description
The relation between the presence in the epileptogenic zone of an activation in the other frequency bands (theta, alpha, beta) in at least 1 of the cognitive tasks performed during the ISD and the occurrence of a post neuropsychological deficit
Time Frame
12 months post-surgery compare to preoperative assessment (SEEG)
Title
micro-electrophysiological recordings
Description
The relation between the presence in the epileptogenic zone of an activation in the other frequency bands (theta, alpha, beta) in at least 1 of the cognitive tasks performed during the ISD and the occurrence of a post neuropsychological deficit
Time Frame
12 months post-surgery compare to preoperative assessment (SEEG)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient adult (18-65 y/o) without legal protection measures
Patient with a drug-resistant focal epilepsy
Patient with a SEEG exploration as part of pre-surgical assessment of epilepsy
patient with a consent form signed
Intellectual capacities compatible with cognitive tasks and the signing of informed consent
Affiliation to the social security
Exclusion Criteria:
Pregnant women: this is already a contraindication to the realization of a SEEG study
Subjects under 18 years of age or over 65 years of age
Patient not suffering from EFPR, or not scheduled for SEEG
Intellectual capacities incompatible with the cognitive tasks and / or the signature of a consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvain RHEIMS, MD
Phone
472359343
Ext
+33
Email
sylvain.rheims@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Laure CHARLOIS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvain RHEIMS, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain RHEIMS, MD
Phone
472359343
Ext
+33
Email
sylvain.rheims@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Anne-Laure CHARLOIS
First Name & Middle Initial & Last Name & Degree
Sylvain RHEIMS, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of the Risk of Cognitive Deficit After Surgery of Epilepsy by Dynamic Spectral Imaging (ISD) of the Cognitive Functions in Patients Explored in StereoElectroEncephaloGraphy (SEEG)
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