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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT03102957

Collaborator

Laboratoire de Psychologie et NeuroCognition (Other)

Enrollment

Arms

86.5

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Other: functional MRI	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 arms : epileptic patient and healthy volonteers2 arms : epileptic patient and healthy volonteers

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jun 17, 2009

Actual Primary Completion Date :

Aug 31, 2016

Actual Study Completion Date :

Aug 31, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

neuronal reorganization exploration in language and memory area thanks to functionnal MRI [one hour for each exam]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Grenoble
Laboratoire de Psychologie et NeuroCognition

Investigators

Principal Investigator: Alexandre KRAINIK, PhD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT03102957

Other Study ID Numbers:

38RC09.21

First Posted:

Apr 6, 2017

Last Update Posted:

Apr 6, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Epilepsy

Study Results

No Results Posted as of Apr 6, 2017