Cartography of Functional and Epileptic Cerebral Areas by Functional MRI and Electroencephalography in Epileptic Patients Before and After Surgery

Exploring the reorganization (plasticity) of neuroanatomic networks associated with language and memory in patients with left (or dominant hemisphere) temporal lobe epilepsy using functional MRI (fMRI)

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Other: functional MRI

Detailed Description

The purpose of this study is to explore the reorganization of neuroanatomic networks associated with language and memory in adult patients with temporal lobe epilepsy (ELT). By using functional MRI, patients will be examined before and after surgery. Cerebral plasticity, defined in terms of intrinsic variables such as the topography of the activated regions, will be explored according to some extrinsic factors such as the age at onset of crises (before or after 5-6 years), whether or not Hippocampal sclerosis, hemispheric predominance of language (left or right).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• epileptic patients
• medical exam before inclusion
• social security affiliation
• Pharmaco-resistant epilepsy

Exclusion Criteria:

• MRI contraindication
• pregnant women
• breastfeeding mothers
• person under tutorship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: epileptic patients; 2 functional MRI (pre and post resective surgery) with memory and language tasks	Other: functional MRI
Other: Healthy volunteers; 1 functional MRI with memory and language tasks	Other: functional MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neuronal reorganization exploration in language and memory area thanks to functionnal MRI	fMRI exam before and after resection surgery of epileptogenic area: assess (plasticity) of neuroanatomic networks associated with language and memory - examined before and after surgery	one hour for each exam

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Laboratoire de Psychologie et NeuroCognition
• Investigators: Principal Investigator: Alexandre KRAINIK, PhD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2009
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 38RC09.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No