EpilepsyNCT00071305
Non-Invasive Seizure Localization in Patients With Medically Refractory Localization Related Epilepsy: Synchronized MEG-EEG Recordings
An observational study of Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2003to 6 Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of age.
- Patients of both sexes and any race or ethnicity who have intractable epilepsy who are deemed surgical candidates and accept epilepsy surgery.
Who cannot join
- Patients younger than 18 years of age.
- Pregnant women.
- Patients who are not surgical candidates.
- Patients who do not accept epilepsy surgery.
- Patients with progressive neurological disorders.
- Patients who are unable to cooperate adequately with MEG/EEG recordings
- Patients who had brain surgery.
- Patients unable to understand and sign consent for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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 Design/Methods:
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 patient's standard pre-surgical evaluation, and compared with the invasive data obtained during chronic invasive monitoring (if clinically indicated), and/or 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.
- Conditions
- Epilepsy
- Keywords
- Magnetoencephalography, Electroencephalography, Epilepsy, Dipole Modeling, Surgery
- Medical subject headings
- Epilepsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2003 (estimated)
- Study start17 Oct 2003
- Primary completion6 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071305
- Sponsor's protocol ID
- 040016
- Other IDs
- 04-N-0016
- Status last verified
- 6 Oct 2009
- First submitted
- 17 Oct 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Amo C, Saldana C, Hidalgo MG, Maestu F, Fernandez A, Arrazola J, Ortiz T. Magnetoencephalographic localization of peritumoral temporal epileptic focus previous surgical resection. Seizure. 2003 Jan;12(1):19-22. doi: 10.1016/s1059131102001486.
PubMed 12495644Baumgartner C, Pataraia E, Lindinger G, Deecke L. Neuromagnetic recordings in temporal lobe epilepsy. J Clin Neurophysiol. 2000 Mar;17(2):177-89. doi: 10.1097/00004691-200003000-00007.
PubMed 10831109Boon P, D'Have M, Vanrumste B, Van Hoey G, Vonck K, Van Walleghem P, Caemaert J, Achten E, De Reuck J. Ictal source localization in presurgical patients with refractory epilepsy. J Clin Neurophysiol. 2002 Oct;19(5):461-8. doi: 10.1097/00004691-200210000-00009.
PubMed 12477991
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Seizure Localization in Patients With Medically Refractory Localization Related Epilepsy: Synchronized MEG-EEG Recordings
- ClinicalTrials.gov ID
- NCT00071305
- Acronym / sponsor ID
- 040016
- Conditions
- Epilepsy
- Keywords
- Magnetoencephalography, Electroencephalography, Epilepsy, Dipole Modeling, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 17 Oct 2003
- Primary completion
- 6 Oct 2009 (actual)
- First posted
- 20 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Design/Methods:
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 patient's standard pre-surgical evaluation, and compared with the invasive data obtained during chronic invasive monitoring (if clinically indicated), and/or 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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients older than 18 years of age.
- Patients of both sexes and any race or ethnicity who have intractable epilepsy who are deemed surgical candidates and accept epilepsy surgery.
Key exclusion criteria (8 listed)
- Patients younger than 18 years of age.
- Pregnant women.
- Patients who are not surgical candidates.
- Patients who do not accept epilepsy surgery.
- Patients with progressive neurological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 12495644Amo C, Saldana C, Hidalgo MG, Maestu F, Fernandez A, Arrazola J, Ortiz T. Magnetoencephalographic localization of peritumoral temporal epileptic focus previous surgical resection. Seizure. 2003 Jan;12(1):19-22. doi: 10.1016/s1059131102001486.
- Background: PubMed 10831109Baumgartner C, Pataraia E, Lindinger G, Deecke L. Neuromagnetic recordings in temporal lobe epilepsy. J Clin Neurophysiol. 2000 Mar;17(2):177-89. doi: 10.1097/00004691-200003000-00007.
- Background: PubMed 12477991Boon P, D'Have M, Vanrumste B, Van Hoey G, Vonck K, Van Walleghem P, Caemaert J, Achten E, De Reuck J. Ictal source localization in presurgical patients with refractory epilepsy. J Clin Neurophysiol. 2002 Oct;19(5):461-8. doi: 10.1097/00004691-200210000-00009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071305, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.