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

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
functional MRI
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    epileptic patients

    Healthy volunteers

    Arm Description

    2 functional MRI (pre and post resective surgery) with memory and language tasks

    1 functional MRI with memory and language tasks

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 22, 2017
    Last Updated
    April 5, 2017
    Sponsor
    University Hospital, Grenoble
    Collaborators
    Laboratoire de Psychologie et NeuroCognition
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03102957
    Brief Title
    Cartography of Functional and Epileptic Cerebral Areas by Functional MRI and Electroencephalography in Epileptic Patients Before and After Surgery
    Official Title
    Cartography of Functional and Epileptic Cerebral Areas by Functional MRI and Electroencephalography in Epileptic Patients Before and After Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 17, 2009 (Actual)
    Primary Completion Date
    August 31, 2016 (Actual)
    Study Completion Date
    August 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Grenoble
    Collaborators
    Laboratoire de Psychologie et NeuroCognition

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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)
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    2 arms : epileptic patient and healthy volonteers
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    epileptic patients
    Arm Type
    Experimental
    Arm Description
    2 functional MRI (pre and post resective surgery) with memory and language tasks
    Arm Title
    Healthy volunteers
    Arm Type
    Other
    Arm Description
    1 functional MRI with memory and language tasks
    Intervention Type
    Other
    Intervention Name(s)
    functional MRI
    Primary Outcome Measure Information:
    Title
    neuronal reorganization exploration in language and memory area thanks to functionnal MRI
    Description
    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
    Time Frame
    one hour for each exam

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexandre KRAINIK, PhD
    Organizational Affiliation
    University Hospital, Grenoble
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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