EpilepsyNCT00706160
Language Mapping in Patients With Epilepsy
An observational study of Epilepsy and Epilepsy, Temporal Lobe, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Epilepsy, Temporal Lobe, Partial Epilepsy
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2008to 4 Apr 2013
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 7-55
- Documentation of localization-related epilepsy based on clinical, neuropsychological and imaging criteria
- Failure of seizures to respond to adequate therapy with at least two standard antiepileptic drugs
- Willingness to be considered for surgery
- Fluency in English. Non-native speakers may be included if their fluency is equivalent to that of a native speaker.
- Age 7-55
Show all 9Show fewer
- Willingness to participate in and complete the study
- Right-handedness assessed by the Edinburg handedness inventory
- Fluency in English
Who cannot join
- Contra-indications to MRI studies (such as pacemakers, cochlear devices, surgical clips etc. metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus nerve stimulator)
- Claustrophobia or anxiety disorders exacerbated by the MRI scanner
- People with neurological or psychiatric disease or taking medications that would affect fMRI and MEG language studies
- Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning
- Patients on phenobarbital or chronic benzodiazepines
- Contra-indications MRI studies (metallic implants, recent orthopedic pins, cochlear implants, surgical clips, cardiac pacemakers and defibrillation devices, shrapnel, permanent eyeliner, vagus nerve stimulator)
- 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.
- Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning.
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
Official title: 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.
Read more
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.
...
Read the 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.
- Conditions
- Epilepsy, Epilepsy, Temporal Lobe, Partial Epilepsy
- Keywords
- Epilepsy, Language, fMRI, Magnetoencephalogram, Temporal Lobe Epilepsy, Partial Epilepsy, Healthy Volunteer, HV
- Medical subject headings
- Epilepsy, Epilepsy, Temporal Lobe, Epilepsies, Partial, Language
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in asymmetry index of fMRI after surgery.
Secondary outcomes (1)
Changes in asymmetry index on MEG after surgery and seizure control after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study start13 Jun 2008
- Study completion4 Apr 2013
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
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Investigators
- William H Theodore, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706160
- Sponsor's protocol ID
- 080161
- Other IDs
- 08-N-0161
- Status last verified
- 4 Apr 2013
- First submitted
- 26 Jun 2008
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Berl MM, Balsamo LM, Xu B, Moore EN, Weinstein SL, Conry JA, Pearl PL, Sachs BC, Grandin CB, Frattali C, Ritter FJ, Sato S, Theodore WH, Gaillard WD. Seizure focus affects regional language networks assessed by fMRI. Neurology. 2005 Nov 22;65(10):1604-11. doi: 10.1212/01.wnl.0000184502.06647.28.
PubMed 16301489Binder JR, Swanson SJ, Hammeke TA, Morris GL, Mueller WM, Fischer M, Benbadis S, Frost JA, Rao SM, Haughton VM. Determination of language dominance using functional MRI: a comparison with the Wada test. Neurology. 1996 Apr;46(4):978-84. doi: 10.1212/wnl.46.4.978.
PubMed 8780076Brookes MJ, Vrba J, Robinson SE, Stevenson CM, Peters AM, Barnes GR, Hillebrand A, Morris PG. Optimising experimental design for MEG beamformer imaging. Neuroimage. 2008 Feb 15;39(4):1788-802. doi: 10.1016/j.neuroimage.2007.09.050. Epub 2007 Oct 10.
PubMed 18155612
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Language Mapping in Patients With Localization-Related Epilepsy
- ClinicalTrials.gov ID
- NCT00706160
- Acronym / sponsor ID
- 080161
- Conditions
- Epilepsy, Epilepsy, Temporal Lobe, Partial Epilepsy
- Keywords
- Epilepsy, Language, fMRI, Magnetoencephalogram, Temporal Lobe Epilepsy, Partial Epilepsy, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 13 Jun 2008
- Study completion
- 4 Apr 2013
- First posted
- 27 Jun 2008 (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 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.
...
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age 7-55
- Willingness to participate in and complete the study
- Right-handedness assessed by the Edinburg handedness inventory
- Fluency in English
Key exclusion criteria (8 listed)
- Contra-indications to MRI studies (such as pacemakers, cochlear devices, surgical clips etc. metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus nerve stimulator)
- Claustrophobia or anxiety disorders exacerbated by the MRI scanner
- People with neurological or psychiatric disease or taking medications that would affect fMRI and MEG language studies
- Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning
- Patients on phenobarbital or chronic benzodiazepines
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
Change in asymmetry index of fMRI after surgery.
1 secondary outcome
Changes in asymmetry index on MEG after surgery and seizure control after surgery.
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 17 Dec 2019.
- Background: PubMed 16301489Berl MM, Balsamo LM, Xu B, Moore EN, Weinstein SL, Conry JA, Pearl PL, Sachs BC, Grandin CB, Frattali C, Ritter FJ, Sato S, Theodore WH, Gaillard WD. Seizure focus affects regional language networks assessed by fMRI. Neurology. 2005 Nov 22;65(10):1604-11. doi: 10.1212/01.wnl.0000184502.06647.28.
- Background: PubMed 8780076Binder JR, Swanson SJ, Hammeke TA, Morris GL, Mueller WM, Fischer M, Benbadis S, Frost JA, Rao SM, Haughton VM. Determination of language dominance using functional MRI: a comparison with the Wada test. Neurology. 1996 Apr;46(4):978-84. doi: 10.1212/wnl.46.4.978.
- Background: PubMed 18155612Brookes MJ, Vrba J, Robinson SE, Stevenson CM, Peters AM, Barnes GR, Hillebrand A, Morris PG. Optimising experimental design for MEG beamformer imaging. Neuroimage. 2008 Feb 15;39(4):1788-802. doi: 10.1016/j.neuroimage.2007.09.050. Epub 2007 Oct 10.
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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.
William H Theodore, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 and Epilepsy, Temporal Lobe, 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 9 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 17 Dec 2019. 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.
What does the primary outcome measure?
Change in asymmetry index of fMRI after surgery.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00706160, 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 17 Dec 2019.