Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071305
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-10-17
Brief Title:
Non-Invasive Seizure Localization in Patients With Medically Refractory Localization Related Epilepsy Synchronized MEG-EEG Recordings
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Non-Invasive Seizure Localization in Patients With Medically Refractory Localization Related Epilepsy Synchronized MEG-EEG Recordings
Status:
COMPLETED
Status Verified Date:
2009-10-06
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 evaluate the magnetoencephalography MEG alone and together with electroencephalography EEG in non-invasive presurgical evaluation It will look at the contribution of those methods in determining the location of the epilepsy seizure compared with doing so through an invasive method EEG measures electronic potential differences on the scalp On the other hand MEG is a non-invasive technique for recording the activity of neurons in the brain through recording of magnetic fields caused by synchronized neural currents It has the ability to detect seizures Because magnetic signals of the brain vary this technique must balance two key problems weakness of the signal and strength of the noise The EEG is sensitive to extra-cellular volume currents whereas the MEG primarily registers intra-cellular currents Because electrical fields are quite dependent on the conductive properties of the tissues and magnetic fields are significantly less distorted by tissue the MEG has better spatial resolution There is a great deal of evidence that EEG and MEG provide complementary data about underlying currents of ions
Patients 18 years of age or older who have epilepsy that is not relieved and who are considered candidates for surgery and who accept epilepsy surgery may be eligible for this study
Before they have surgery participants will either sit or lie down with their head in a helmet covering the entire head with openings for the eyes and ears Brain magnetic fields will be recorded with a 275-channel OMEGA system Throughout the session visual and two-way audio communication will be maintained with the patient Acquiring data from the participant will be conducted during several sessions each lasting from 10 to 60 minutes not exceeding a total of 120 minutes If the first recording is not of sufficient quality the patient may have it repeated once or twice
Those participants who are found to have a clear seizure focus will proceed directly to surgery that is part of their treatment Those whose seizure focus is ambiguous will proceed to invasive monitoring
Participants will be followed in the outpatient clinic at intervals of 1 3 6 and 12 months They may periodically undergo reimaging as considered appropriate
Patients 18 years of age or older who have epilepsy that is not relieved and who are considered candidates for surgery and who accept epilepsy surgery may be eligible for this study
Before they have surgery participants will either sit or lie down with their head in a helmet covering the entire head with openings for the eyes and ears Brain magnetic fields will be recorded with a 275-channel OMEGA system Throughout the session visual and two-way audio communication will be maintained with the patient Acquiring data from the participant will be conducted during several sessions each lasting from 10 to 60 minutes not exceeding a total of 120 minutes If the first recording is not of sufficient quality the patient may have it repeated once or twice
Those participants who are found to have a clear seizure focus will proceed directly to surgery that is part of their treatment Those whose seizure focus is ambiguous will proceed to invasive monitoring
Participants will be followed in the outpatient clinic at intervals of 1 3 6 and 12 months They may periodically undergo reimaging as considered appropriate
Detailed Description:
Objective
We will use magnetoencephalography MEG alone and in combination with EEG MEG-EEG to study the contribution of each method and their combination to the localizing yield of the non-invasive pre-surgical evaluation as compared to the invasive method We will also correlate seizure origin and localizing data with surgical outcome and in retrospect calculate the proportion of patients in whom invasive monitoring could have been avoided
Study Population
Participants in this study will be patients with medically refractory localization-related epilepsy who will be undergoing epilepsy surgery as part of their standard clinical care
Study DesignMethods
We will use a 275-channel whole-head MEG System CTF Systems 2001 Inc Patients will undergo a supine resting MEG-EEG recording prior to any surgical procedure The resulting data will be integrated with the data obtained during the patients standard pre-surgical evaluation and compared with the invasive data obtained during chronic invasive monitoring if clinically indicated andor intra-operative electrocorticography all patients-standard of care When analyzing the data readers will be blinded to the results of the other modality MEG vs EEG non-invasive vs invasive
The patients will be followed in the outpatient clinic at 1- 3- 6- and 12-month intervals Surgical outcomes will be graded according to the Engel and International League Against Epilepsy ILAE outcome scales
The findings from this protocol will not in themselves indicate or lead to epilepsy surgery
Outcomes
The primary outcome measure will be the proportion of seizure foci detected and delineated both non-invasively and invasively The secondary outcome measures will be the proportion of patients with seizure foci co-localized invasively and non-invasively the correlation of the obtained localizing data from both modalities with surgical outcome and the correlation between the anatomical location of the epileptogenic zone and surgical outcome
We will use magnetoencephalography MEG alone and in combination with EEG MEG-EEG to study the contribution of each method and their combination to the localizing yield of the non-invasive pre-surgical evaluation as compared to the invasive method We will also correlate seizure origin and localizing data with surgical outcome and in retrospect calculate the proportion of patients in whom invasive monitoring could have been avoided
Study Population
Participants in this study will be patients with medically refractory localization-related epilepsy who will be undergoing epilepsy surgery as part of their standard clinical care
Study DesignMethods
We will use a 275-channel whole-head MEG System CTF Systems 2001 Inc Patients will undergo a supine resting MEG-EEG recording prior to any surgical procedure The resulting data will be integrated with the data obtained during the patients standard pre-surgical evaluation and compared with the invasive data obtained during chronic invasive monitoring if clinically indicated andor intra-operative electrocorticography all patients-standard of care When analyzing the data readers will be blinded to the results of the other modality MEG vs EEG non-invasive vs invasive
The patients will be followed in the outpatient clinic at 1- 3- 6- and 12-month intervals Surgical outcomes will be graded according to the Engel and International League Against Epilepsy ILAE outcome scales
The findings from this protocol will not in themselves indicate or lead to epilepsy surgery
Outcomes
The primary outcome measure will be the proportion of seizure foci detected and delineated both non-invasively and invasively The secondary outcome measures will be the proportion of patients with seizure foci co-localized invasively and non-invasively the correlation of the obtained localizing data from both modalities with surgical outcome and the correlation between the anatomical location of the epileptogenic zone and surgical outcome
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 |
|---|---|---|---|
| 04-N-0016 | None | None | None |