Status:

COMPLETED

Language Mapping in Patients With Epilepsy

Lead Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Conditions:

Epilepsy

Epilepsy, Temporal Lobe

Eligibility:

All Genders

7-55 years

Brief Summary

This study will examine how certain language skills, such as naming objects, understanding spoken language and reading are organized in the brain and how they are affected by seizures. People with ep...

Detailed Description

Objective: This protocol will test the hypothesis that successful left hemisphere epilepsy surgery for children and adults improves abnormalities in the functional anatomy of language that may be asso...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA FOR PATIENTS:
  • Age 7-55
  • Documentation of localization-related epilepsy based on clinical, neuropsychological and imaging criteria
  • Failure of seizures to respond to adequate therapy with at least two standard antiepileptic drugs
  • Willingness to be considered for surgery
  • Fluency in English. Non-native speakers may be included if their fluency is equivalent to that of a native speaker.
  • INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
  • Age 7-55
  • Willingness to participate in and complete the study
  • Right-handedness assessed by the Edinburg handedness inventory
  • Fluency in English
  • EXCLUSION CRITERIA FOR PATIENTS:
  • Contra-indications to MRI studies (such as pacemakers, cochlear devices, surgical clips etc. metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus nerve stimulator)
  • Claustrophobia or anxiety disorders exacerbated by the MRI scanner
  • People with neurological or psychiatric disease or taking medications that would affect fMRI and MEG language studies
  • Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning
  • Patients on phenobarbital or chronic benzodiazepines
  • EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
  • Contra-indications MRI studies (metallic implants, recent orthopedic pins, cochlear implants, surgical clips, cardiac pacemakers and defibrillation devices, shrapnel, permanent eyeliner, vagus nerve stimulator)
  • Any medical condition or chronic medication that might affect fMRI or MEG language activation by affecting cerebral structure or function, such as diabetes, hypertension, antihypertensive medications, psychotropic agents.
  • Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning.

Exclusion

    Key Trial Info

    Start Date :

    June 13 2008

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    April 4 2013

    Estimated Enrollment :

    153 Patients enrolled

    Trial Details

    Trial ID

    NCT00706160

    Start Date

    June 13 2008

    End Date

    April 4 2013

    Last Update

    December 17 2019

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892