NCT Number: NCT02869698
Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored Stereoelectroencephalography
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.
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Age range
6 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
University Hospital Grenoble, Grenoble, France
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Hybride electrode
DeviceOther names: AdTech Medical Instrument Corporation
Macro electrode
DeviceOther names: DIXI Microtechniques
Primary outcomes
-
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
Sponsors and collaborators
Lead sponsor
University Hospital, Grenoble
Other
Registry information
Official study title
Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored
Acronym: ISDETSEEG
Important dates
- Study start
- 2009
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Aug 17, 2016
- Registry last updated
- Oct 27, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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