Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored Stereoelectroencephalography

Epilepsy Clinical Trial

— ISDETSEEG  

Official title:

Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869698
• Other study ID #: 38RC09.012
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: October 25, 2017
• Start date: June 2009
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Procedure:
• Spectral Dynamic Imaging

Device:
• Hybride electrode

• Macro electrode

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble
France	University Hospital Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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