Ignite Creation Date:
2024-05-05 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00706160
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2008-06-26
Brief Title:
Language Mapping in Patients With Epilepsy
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Noninvasive Language Mapping in Patients With Localization-Related Epilepsy
Status:
COMPLETED
Status Verified Date:
2013-04-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 08-N-0161 | None | None | None |