Epilepsies, PartialNCT00072813
MRI in Autosomal Dominant Partial Epilepsy With Auditory Features
An observational study of Epilepsies, Partial, run by National Institute of Neurological Disorders and Stroke (NINDS) at 2 sites in United States.
Trial summary
This study will examine the possible structural and functional abnormalities in patients with an inherited form of epilepsy. It will use magnetic resonance imaging (MRI). Uncontrolled epilepsy is a serious neurological problem with major harmful medical, social, and psychological effects, as well as greater mortality… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsies, Partial
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2003to 12 Nov 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients and family members in kindreds with ADPEAF evaluated by Dr. Ruth Ottman at CPMC:
- 14 patients with seizures and the LGl1 mutation.
- 14 family members with the mutation but no seizures.
- 14 Non-affected family members, who are not carriers of the LGl1 mutation.
- 30 normal controls selected at NIH, and screened in the CES outpatient clinic with a physical and neurological examination.
Who cannot join
- Subjects unable or unwilling to undergo MRI, EEG, and MEG.
- Women who are pregnant.
- Subjects under 18.
- Subjects with medical conditions other than ADPEAF that may affect brain function.
- Subjects taking medications or neuroactive substances that may affect brain function.
- Healthy volunteers must be below the age of 55, to reduce the chance of vascular chnages that could affect MRI.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Columbia University
New York, New York, 10032-3784
About this study
This study will examine the possible structural and functional abnormalities in patients with an inherited form of epilepsy. It will use magnetic resonance imaging (MRI). Uncontrolled epilepsy is a serious neurological problem with major harmful medical, social, and psychological effects, as well as greater mortality compared with the general population. The cost per year in the United States is at least $12.5 billion. There have been advances in diagnosing the disease, but the cause cannot be determined in many cases. Recently, several seizure syndromes found in families have been described. One syndrome of particular interest involves the lateral temporal lobe of the brain and often includes auditory features. Patients with that kind of syndrome may hear monotonous unformed sounds, but sometimes they may hear complex sounds, such as a song.
Patients are eligible for this study if they have a specific form of familial epilepsy that is being studied at Columbia University in New York. Family members without seizures are eligible as well. All the patients in the study will be evaluated at Columbia before participating. Healthy volunteers aged 18 to 55 also may be eligible for this study.
Read more
Participants will undergo a medical history and physical examination. During the study, they may have three or four sessions of MRI. During the MRI, patients will lie still on a table that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Patients may be asked to lie still for up to 60 minutes at a time. As the scanner takes pictures, there will be loud knocking noises, and the patients will wear earplugs to muffle the sound. Patients will be able to communicate with the MRI staff at all times during the scan and may ask to be moved out of the machine at any time. Some scans may be done in a 3 Tesla scanner. It is the latest advance in MRI, with a stronger magnetic field than in the more common 1.5 Tesla scanner. Functional MRI (fMRI) is done while patients are performing tasks, such as moving a limb or speaking. Patients will have an opportunity to practice such tasks before entering the scanner. The fMRI will take about 1 hour.
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Read the detailed description
Objectives: to study potential structural and functional abnormalities in patients with an inherited form of epilepsy.
Study Population: Patients with autosomal dominant partial epilepsy with auditory features, a newly described syndrome, asymptomatic family members who are gene carriers, and unaffected family members, and normal volunteers.
Design: magnetic resonance imaging, electroencephalography, and magnetoencephalography.
Outcome measures: detection of structural lesions; regional activation patterns on fMRI.
- Conditions
- Epilepsies, Partial
- Keywords
- Genetics, Seizures, Brain Imaging, Diffusion, Temporal Lobe
- Medical subject headings
- Epilepsies, Partial, Seizures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2003 (estimated)
- Study start10 Nov 2003
- Primary completion12 Nov 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 Epilepsies, PartialStudies 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
- 72 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
- NCT00072813
- Sponsor's protocol ID
- 040033
- Other IDs
- 04-N-0033
- Status last verified
- 12 Nov 2009
- First submitted
- 10 Nov 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Baker GA, Nashef L, van Hout BA. Current issues in the management of epilepsy: the impact of frequent seizures on cost of illness, quality of life, and mortality. Epilepsia. 1997;38 Suppl 1:S1-8. doi: 10.1111/j.1528-1157.1997.tb04511.x.
PubMed 9092951Bastos AC, Korah IP, Cendes F, Melanson D, Tampieri D, Peters T, Dubeau F, Andermann F. Curvilinear reconstruction of 3D magnetic resonance imaging in patients with partial epilepsy: a pilot study. Magn Reson Imaging. 1995;13(8):1107-12. doi: 10.1016/0730-725x(95)02019-p.
PubMed 8750323Bastos AC, Comeau RM, Andermann F, Melanson D, Cendes F, Dubeau F, Fontaine S, Tampieri D, Olivier A. Diagnosis of subtle focal dysplastic lesions: curvilinear reformatting from three-dimensional magnetic resonance imaging. Ann Neurol. 1999 Jul;46(1):88-94. doi: 10.1002/1531-8249(199907)46:13.0.co;2-4.
PubMed 10401784
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
- MRI in Autosomal Dominant Partial Epilepsy With Auditory Features
- ClinicalTrials.gov ID
- NCT00072813
- Acronym / sponsor ID
- 040033
- Conditions
- Epilepsies, Partial
- Keywords
- Genetics, Seizures, Brain Imaging, Diffusion, Temporal Lobe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 10 Nov 2003
- Primary completion
- 12 Nov 2009 (actual)
- First posted
- 11 Nov 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 examine the possible structural and functional abnormalities in patients with an inherited form of epilepsy. It will use magnetic resonance imaging (MRI). Uncontrolled epilepsy is a serious neurological problem with major harmful medical, social, and psychological effects, as well as greater mortality compared with the general population. The cost per year in the United States is at least $12.5 billion. There have been advances in diagnosing the disease, but the cause cannot be determined in many cases. Recently, several seizure syndromes found in families have been described. One syndrome of particular interest involves the lateral temporal lobe of the brain and often includes auditory features. Patients with that kind of syndrome may hear monotonous unformed sounds, but sometimes they may hear complex sounds, such as a song.
Patients are eligible for this study if they have a specific form of familial epilepsy that is being studied at Columbia University in New York. Family members without seizures are eligible as well. All the patients in the study will be evaluated at Columbia before participating. Healthy volunteers aged 18 to 55 also may be eligible for this study.
Participants will undergo a medical history and physical examination. During the study, they may have three or four sessions of MRI. During the MRI, patients will lie still on a table that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Patients may be asked to lie still for up to 60 minutes at a time. As the scanner takes pictures, there will be loud knocking noises, and the patients will wear earplugs to muffle the sound. Patients will be able to communicate with the MRI staff at all times during the scan and may ask to be moved out of the machine at any time. Some scans may be done in a 3 Tesla scanner. It is the latest advance in MRI, with a stronger magnetic field than in the more common 1.5 Tesla scanner. Functional MRI (fMRI) is done while patients are performing tasks, such as moving a limb or speaking. Patients will have an opportunity to practice such tasks before entering the scanner. The fMRI will take about 1 hour.
...
Detailed description
Objectives: to study potential structural and functional abnormalities in patients with an inherited form of epilepsy.
Study Population: Patients with autosomal dominant partial epilepsy with auditory features, a newly described syndrome, asymptomatic family members who are gene carriers, and unaffected family members, and normal volunteers.
Design: magnetic resonance imaging, electroencephalography, and magnetoencephalography.
Outcome measures: detection of structural lesions; regional activation patterns on fMRI.
Study design
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 14 patients with seizures and the LGl1 mutation.
- 14 family members with the mutation but no seizures.
- 14 Non-affected family members, who are not carriers of the LGl1 mutation.
- 30 normal controls selected at NIH, and screened in the CES outpatient clinic with a physical and neurological examination.
Key exclusion criteria (6 listed)
- Subjects unable or unwilling to undergo MRI, EEG, and MEG.
- Women who are pregnant.
- Subjects under 18.
- Subjects with medical conditions other than ADPEAF that may affect brain function.
- Subjects taking medications or neuroactive substances that may affect brain function.
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 9092951Baker GA, Nashef L, van Hout BA. Current issues in the management of epilepsy: the impact of frequent seizures on cost of illness, quality of life, and mortality. Epilepsia. 1997;38 Suppl 1:S1-8. doi: 10.1111/j.1528-1157.1997.tb04511.x.
- Background: PubMed 8750323Bastos AC, Korah IP, Cendes F, Melanson D, Tampieri D, Peters T, Dubeau F, Andermann F. Curvilinear reconstruction of 3D magnetic resonance imaging in patients with partial epilepsy: a pilot study. Magn Reson Imaging. 1995;13(8):1107-12. doi: 10.1016/0730-725x(95)02019-p.
- Background: PubMed 10401784Bastos AC, Comeau RM, Andermann F, Melanson D, Cendes F, Dubeau F, Fontaine S, Tampieri D, Olivier A. Diagnosis of subtle focal dysplastic lesions: curvilinear reformatting from three-dimensional magnetic resonance imaging. Ann Neurol. 1999 Jul;46(1):88-94. doi: 10.1002/1531-8249(199907)46:13.0.co;2-4.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsies, Partial, run by National Institute of Neurological Disorders and Stroke (NINDS) at 2 sites 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 5 inclusion and 6 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 2 sites 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 NCT00072813, 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.