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

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ClinicalTrials.gov Identifier: NCT03102957
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
Laboratoire de Psychologie et NeuroCognition
Information provided by (Responsible Party):
University Hospital, Grenoble

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 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 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 : June 17, 2009
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : August 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Memory

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



Primary Outcome Measures :
  1. neuronal reorganization exploration in language and memory area thanks to functionnal MRI [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102957


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

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03102957     History of Changes
Other Study ID Numbers: 38RC09.21
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases