SeizuresNCT00884351
Magnetoencephalography in Absence Seizures
An observational study of Seizures, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: An absence seizure is a type of seizure that usually begins in childhood and goes away by early adulthood. Scientists do not yet know where absence seizures begin in the brain. Read more about this study
- Who is it for?
- Ages 7 to 35 years
- Conditions the study is for
- Seizures
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2009to 15 Jun 2011
- 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 7 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 7-35
- Absence of seizures based on clinical and electroenecephalography data. Patients who have other seizure types (myoclonic, generalized tonic-clonic) in addition to absence seizures may be included.
- Patients who have other neurologic disorders may be included, as long as they are able to consent/assent.
Who cannot join
- Contraindications to MEG studies (Dental braces, permanent retainers, metal dental caps/crowns/fillings)
- Contraindications to MRI studies (such as pacemakers, cochlear devices, surgical clips, metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus nerve stimulator)
- Claustrophobia or anxiety disorders exacerbated by MRI
- Pregnancy
- Inability to provide consent/assent
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
Background:
- An absence seizure is a type of seizure that usually begins in childhood and goes away by early adulthood. Scientists do not yet know where absence seizures begin in the brain. Some evidence suggests that these seizures begin in the thalamus, a structure deep in the brain, but other studies suggest that they begin in the frontal cortex, at the front part of the brain.
- Magnetoencephalography is a type of brain scanning procedure that is useful in determining information about what happens to the brain during epileptic seizures. Understanding where absence seizures come from may help doctors find new treatments for them.
Read more
Objectives:
- To gain a better understanding of which parts of the brain are affected in absence seizures.
Eligibility:
- Patients 7 to 35 years of age who have been diagnosed with absence seizures.
Design:
- Procedures are for research purposes only, not to diagnose or treat a particular medical condition.
- Two outpatient visits to the National Institutes of Health Clinical Center: evaluation and scanning.
- Researchers will evaluate potential participants with a medical history, physical examination, and electroencephalography (EEG). These tests will be performed under another protocol, 01-N-0139.
- Patients will undergo magnetoencephalography (MEG) and magnetic resonance imaging (MRI) of the brain. The study procedures will be performed one time; however, an MEG or MRI scan may need to be repeated for technical reasons. Researchers will not do more than two MEG or MRI scans.
- The MEG will record very small magnetic field changes produced by the activity of the brain. An EEG will be recorded at the same time as the MEG.
- The MRI will use a magnetic field to take pictures of the inside of the brain.
- The MEG will take 3 hours to complete (2 hours for preparation, 1 hour in the scanner). The MRI will take approximately 1 hour.
Read the detailed description
Objective:
This protocol will test the hypothesis that the 3-Hz spike-wave discharges seen in absence epilepsy originate in the thalamus. We will use an emerging modality, magnetoencephalograpy (MEG), to test this hypothesis.
Study Population:
33 patients with absence seizures.
Design:
This is a non-invasive imaging study that involves a 275-channel whole head MEG recording and a structural MRI for co-registration of MEG data.
Outcome Measure:
The primary outcome measure is the source localization of spike-wave discharges on magnetoencephalography.
- Conditions
- Seizures
- Keywords
- Epilepsy, MEG, Seizures
- Medical subject headings
- Seizures, Epilepsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study start15 Apr 2009
- Study completion15 Jun 2011
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 SeizuresStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884351
- Sponsor's protocol ID
- 090125
- Other IDs
- 09-N-0125
- Status last verified
- 15 Jun 2011
- First submitted
- 17 Apr 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Avoli M, Gloor P. Role of the thalamus in generalized penicillin epilepsy: observations on decorticated cats. Exp Neurol. 1982 Aug;77(2):386-402. doi: 10.1016/0014-4886(82)90252-7. No abstract available.
PubMed 7095066Bernasconi A, Bernasconi N, Natsume J, Antel SB, Andermann F, Arnold DL. Magnetic resonance spectroscopy and imaging of the thalamus in idiopathic generalized epilepsy. Brain. 2003 Nov;126(Pt 11):2447-54. doi: 10.1093/brain/awg249. Epub 2003 Aug 5.
PubMed 12902313Castro-Alamancos MA. Neocortical synchronized oscillations induced by thalamic disinhibition in vivo. J Neurosci. 1999 Sep 15;19(18):RC27. doi: 10.1523/JNEUROSCI.19-18-j0005.1999.
PubMed 10479720
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
- Magnetoencephalography in Absence Seizures
- ClinicalTrials.gov ID
- NCT00884351
- Acronym / sponsor ID
- 090125
- Conditions
- Seizures
- Keywords
- Epilepsy, MEG, Seizures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 15 Apr 2009
- Study completion
- 15 Jun 2011
- First posted
- 20 Apr 2009 (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.
Background:
- An absence seizure is a type of seizure that usually begins in childhood and goes away by early adulthood. Scientists do not yet know where absence seizures begin in the brain. Some evidence suggests that these seizures begin in the thalamus, a structure deep in the brain, but other studies suggest that they begin in the frontal cortex, at the front part of the brain.
- Magnetoencephalography is a type of brain scanning procedure that is useful in determining information about what happens to the brain during epileptic seizures. Understanding where absence seizures come from may help doctors find new treatments for them.
Objectives:
- To gain a better understanding of which parts of the brain are affected in absence seizures.
Eligibility:
- Patients 7 to 35 years of age who have been diagnosed with absence seizures.
Design:
- Procedures are for research purposes only, not to diagnose or treat a particular medical condition.
- Two outpatient visits to the National Institutes of Health Clinical Center: evaluation and scanning.
- Researchers will evaluate potential participants with a medical history, physical examination, and electroencephalography (EEG). These tests will be performed under another protocol, 01-N-0139.
- Patients will undergo magnetoencephalography (MEG) and magnetic resonance imaging (MRI) of the brain. The study procedures will be performed one time; however, an MEG or MRI scan may need to be repeated for technical reasons. Researchers will not do more than two MEG or MRI scans.
- The MEG will record very small magnetic field changes produced by the activity of the brain. An EEG will be recorded at the same time as the MEG.
- The MRI will use a magnetic field to take pictures of the inside of the brain.
- The MEG will take 3 hours to complete (2 hours for preparation, 1 hour in the scanner). The MRI will take approximately 1 hour.
Detailed description
Objective:
This protocol will test the hypothesis that the 3-Hz spike-wave discharges seen in absence epilepsy originate in the thalamus. We will use an emerging modality, magnetoencephalograpy (MEG), to test this hypothesis.
Study Population:
33 patients with absence seizures.
Design:
This is a non-invasive imaging study that involves a 275-channel whole head MEG recording and a structural MRI for co-registration of MEG data.
Outcome Measure:
The primary outcome measure is the source localization of spike-wave discharges on magnetoencephalography.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (5 listed)
- Contraindications to MEG studies (Dental braces, permanent retainers, metal dental caps/crowns/fillings)
- Contraindications to MRI studies (such as pacemakers, cochlear devices, surgical clips, metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus nerve stimulator)
- Claustrophobia or anxiety disorders exacerbated by MRI
- Pregnancy
- Inability to provide consent/assent
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 7095066Avoli M, Gloor P. Role of the thalamus in generalized penicillin epilepsy: observations on decorticated cats. Exp Neurol. 1982 Aug;77(2):386-402. doi: 10.1016/0014-4886(82)90252-7. No abstract available.
- Background: PubMed 12902313Bernasconi A, Bernasconi N, Natsume J, Antel SB, Andermann F, Arnold DL. Magnetic resonance spectroscopy and imaging of the thalamus in idiopathic generalized epilepsy. Brain. 2003 Nov;126(Pt 11):2447-54. doi: 10.1093/brain/awg249. Epub 2003 Aug 5.
- Background: PubMed 10479720Castro-Alamancos MA. Neocortical synchronized oscillations induced by thalamic disinhibition in vivo. J Neurosci. 1999 Sep 15;19(18):RC27. doi: 10.1523/JNEUROSCI.19-18-j0005.1999.
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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 Seizures, 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 3 inclusion and 5 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 NCT00884351, 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.