Language Mapping in Patients With Epilepsy
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 7 - 55 |
| Updated: | 4/6/2019 |
| Start Date: | June 13, 2008 |
| End Date: | April 4, 2013 |
Noninvasive Language Mapping in Patients With Localization-Related Epilepsy
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 epilepsy who are considering surgery and healthy volunteers who are right-handed
and between the ages of 7 and 55 may be eligible for this study. Participants undergo the
following procedures twice, and, in some cases, possibly three times, in two or three visits
of 2 to 4 hours each.
Neuropsychological tests: Testing includes questionnaires, pen-and-pencil or computerized
tests and motor tasks.
Structural MRI: This procedure uses a strong magnetic field and radio waves to obtain
pictures of brain structure. During the test, the subject lies in the scanner (a metal
cylinder surrounded by a magnetic field) for about 90 minutes, wearing earmuffs to muffle
knocking noises the machine makes. Subjects may be asked to lie still for up to 10 minutes at
a time.
Functional MRI: This procedure is similar to structural MRI, except a coil is placed over the
head and the subject performs simple tasks during the procedure. The pictures obtained show
what parts of the brain are being used to perform the task. The test lasts about 60 minutes,
with subjects asked to lie still for up to 10 minutes at a time.
Magnetoencephalography (MEG) and electroencephalography (EEG): For MEG, the subject sits in
an MEG recording room with a cone containing magnetic field detectors lowered onto his or her
head. Very small magnetic changes produced by the activity of the brain are recorded while
the subject sits quietly or performs a research task. An EEG recording of the electrical
activity of the brain is done at the same time as the MEG.
spoken language and reading are organized in the brain and how they are affected by seizures.
People with epilepsy who are considering surgery and healthy volunteers who are right-handed
and between the ages of 7 and 55 may be eligible for this study. Participants undergo the
following procedures twice, and, in some cases, possibly three times, in two or three visits
of 2 to 4 hours each.
Neuropsychological tests: Testing includes questionnaires, pen-and-pencil or computerized
tests and motor tasks.
Structural MRI: This procedure uses a strong magnetic field and radio waves to obtain
pictures of brain structure. During the test, the subject lies in the scanner (a metal
cylinder surrounded by a magnetic field) for about 90 minutes, wearing earmuffs to muffle
knocking noises the machine makes. Subjects may be asked to lie still for up to 10 minutes at
a time.
Functional MRI: This procedure is similar to structural MRI, except a coil is placed over the
head and the subject performs simple tasks during the procedure. The pictures obtained show
what parts of the brain are being used to perform the task. The test lasts about 60 minutes,
with subjects asked to lie still for up to 10 minutes at a time.
Magnetoencephalography (MEG) and electroencephalography (EEG): For MEG, the subject sits in
an MEG recording room with a cone containing magnetic field detectors lowered onto his or her
head. Very small magnetic changes produced by the activity of the brain are recorded while
the subject sits quietly or performs a research task. An EEG recording of the electrical
activity of the brain is done at the same time as the MEG.
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 associated with uncontrolled localization-related seizures. We will use an
established modality, functional magnetic resonance imaging (fMRI), which has been used
extensively for evaluation of patients with epilepsy, as our primary outcome measure, and an
emerging modality, magnetoencephalography (MEG), as a secondary measure. We will explore
methods of MEG data analysis for comparison with fMRI results.
Study Population:
150 patients with localization-related epilepsy who are surgical candidates and 50 healthy
volunteers.
Design: This is a non-invasive imaging study that will employ a test battery including
standard neuropsychological tests, structural MRI, fMRI, and a 275-channel whole-head MEG
recording, for evaluation of the functional anatomy of language. The test battery will be
performed pre-operatively and at 12 months after surgery.
Main outcome measure: Measurement of the "laterality index" comparing left and right
hemisphere regional activation on fMRI before and after surgery, in patients after left sided
or right-sided surgery, and healthy controls.
Secondary outcome measure: Measurement of the "laterality index" comparing left and right
hemisphere regional activation on MEG before and after surgery.
surgery for children and adults improves abnormalities in the functional anatomy of language
that may be associated with uncontrolled localization-related seizures. We will use an
established modality, functional magnetic resonance imaging (fMRI), which has been used
extensively for evaluation of patients with epilepsy, as our primary outcome measure, and an
emerging modality, magnetoencephalography (MEG), as a secondary measure. We will explore
methods of MEG data analysis for comparison with fMRI results.
Study Population:
150 patients with localization-related epilepsy who are surgical candidates and 50 healthy
volunteers.
Design: This is a non-invasive imaging study that will employ a test battery including
standard neuropsychological tests, structural MRI, fMRI, and a 275-channel whole-head MEG
recording, for evaluation of the functional anatomy of language. The test battery will be
performed pre-operatively and at 12 months after surgery.
Main outcome measure: Measurement of the "laterality index" comparing left and right
hemisphere regional activation on fMRI before and after surgery, in patients after left sided
or right-sided surgery, and healthy controls.
Secondary outcome measure: Measurement of the "laterality index" comparing left and right
hemisphere regional activation on MEG before and after surgery.
- INCLUSION CRITERIA FOR PATIENTS:
1. Age 7-55
2. Documentation of localization-related epilepsy based on clinical,
neuropsychological and imaging criteria
3. Failure of seizures to respond to adequate therapy with at least two standard
antiepileptic drugs
4. Willingness to be considered for surgery
5. 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:
1. Age 7-55
2. Willingness to participate in and complete the study
3. Right-handedness assessed by the Edinburg handedness inventory
4. Fluency in English
EXCLUSION CRITERIA FOR PATIENTS:
1. Contra-indications to MRI studies (such as pacemakers, cochlear devices, surgical
clips etc. metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus
nerve stimulator)
2. Claustrophobia or anxiety disorders exacerbated by the MRI scanner
3. People with neurological or psychiatric disease or taking medications that would
affect fMRI and MEG language studies
4. Pregnancy. All females of child bearing potential must have a negative test prior to
MRI scanning
5. Patients on phenobarbital or chronic benzodiazepines
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
1. Contra-indications MRI studies (metallic implants, recent orthopedic pins, cochlear
implants, surgical clips, cardiac pacemakers and defibrillation devices, shrapnel,
permanent eyeliner, vagus nerve stimulator)
2. 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.
3. Pregnancy. All females of child bearing potential must have a negative test prior to
MRI scanning.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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