Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored Stereoelectroencephalography

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Procedure: Spectral Dynamic Imaging; Device: Hybride electrode; Device: Macro electrode

• Registration Number: NCT02869698
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-17
• Primary Completion: 2017-05
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluation of cognitive functions by Spectral Dynamic Imaging	Hybride electrode	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
Evaluation of cognitive functions by Spectral Dynamic Imaging	Spectral Dynamic Imaging	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
Evaluation of cognitive functions by Spectral Dynamic Imaging	Macro electrode	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

Primary Outcome Measures

Name	Time	Method
Functional brain mapping procedure using the EEG signal intracranial to minimize the risk of cognitive deficits associated with resection of the epileptogenic zone.	3 weeks

Trial Locations

Locations (2)

University Hospital Lyon; 🇫🇷 Lyon, France

University Hospital Grenoble; 🇫🇷 Grenoble, France