Focal Cortical DysplasiaFCPNCT00687024
Determining the Extent of Diffusion Tensor Abnormalities in Focal Cortical Dysplasia
An observational study of Focal Cortical Dysplasia and Epilepsy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Focal cortical dysplasia (FCD) is a common finding in epilepsy surgery in pediatric patients. Children with intractable epilepsy would have extensive tests to identify the cause of epilepsy; this includes MR brain, video EEG and magnetoencephalography (MEG). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Focal Cortical Dysplasia, Epilepsy
- What is being tested?
- Magnetoencephalography, MR imaging and Diffusion Tensor Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Jun 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with suspected FCD presenting with intractable epilepsy for MRI \& MEG. The children will be identified from referral for clinical MRI scans.
Who may be able to join
- Children with intractable epilepsy with suspected FCD for MRI \& MEG
Who cannot join
- Children with contraindications to MRI such as those with pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Focal cortical dysplasia (FCD) is a common finding in epilepsy surgery in pediatric patients. Children with intractable epilepsy would have extensive tests to identify the cause of epilepsy; this includes MR brain, video EEG and magnetoencephalography (MEG). The white matter next to FCD is frequently found to be abnormal on pathology. Diffusion tensor imaging (DTI) can be used to study the abnormal white matter and the area that often extends beyond the area that is visible.
Read the detailed description
Focal cortical dysplasia (FCD) is a highly epileptogenic form of malformation of cortical development that may require surgical resection for epilepsy control. With abnormal development and organization of neurons within the cortex, the white matter projecting from the abnormal cortex is likely to be abnormal as well. The abnormality in the white matter involves not only the subcortical white matter, but also the long tracts in the deep white matter associated with the dysplastic cortex. Histologically, the subcortical white matter adjacent to the dysplastic cortex has been found to be abnormal. Studies using diffusion tensor imaging (DTI) to investigate the white matter adjacent to the MR visible abnormality have demonstrated reduced fractional anisotropy. However, electrographic abnormality in FCD often extends beyond the visible MR abnormality and surgical outcome of epilepsy surgery in FCD is dependent on excising the MR visible abnormality as well as electrographically abnormal area beyond the MR visible abnormality. The cortical and white matter abnormalities are therefore assumed to extend beyond the MR visible lesion. The short-term goal of this study is to determine whether quantitative measures of the abnormal white matter using DTI are able to provide surrogate markers for the extent of FCD. Whilst surgical outcome data is not available for the purpose of this study, these children will be followed up and in the longer term, the extent of FCD as determined by DTI will be compared with clinical outcome post surgery. This study will help determine the potential value of this technique in identifying areas of FCD that appear normal on structural MR. In the long term, this technique can be extended to study children with intractable epilepsy with (i) MR occult lesion and (ii) developmental tumor with MR occult FCD adjacent to the tumor.
- Conditions
- Focal Cortical Dysplasia, Epilepsy
- Being tested
- Magnetoencephalography, MR imaging, Diffusion Tensor Imaging
- Keywords
- Epilepsy, Magnetic Resonance Imaging, Magnetoencephalography
- Medical subject headings
- Focal Cortical Dysplasia, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetoencephalographyProcedure or surgery
MEG will be performed on a whole head Omega 151-channel gradiometer system. At least 15 2-minute periods of spontaneous data are recorded. The sampling rate for data acquisition is 625Hz, with a bandpass filter of 3 to 70 Hz and a notch filter of 60Hz.
MR imagingProcedure or surgery
MR imaging will be performed on a GE 1.5T system using a variety of sequences, including sagittal T1, axial T2, axial FLAIR, coronal dual echo, coronal FLAIR, axial 3D T2 frFSE and axial SPGR.
Diffusion Tensor ImagingProcedure or surgery
Diffusion tensor imaging will be performed on the same scanner, using single shot diffusion-weighted echo planar imaging. Twenty-five 'xial contiguous slices are obtained aligned to the anterior commissure line to cover the whole brain, giving a total imaging time of 4min 40sec.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the subcortical white matter in the visualized MR abnormality as well as beyond the visualized MR abnormality but subjacent to the MEG dipoles
Measured: Immediately after MEG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startMay 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Cortical DysplasiaStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Raybaud, The Hospital for Sick Children
- Investigators
- Charles Raybaud, M.D., Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687024
- Sponsor's protocol ID
- 1000010634
- Acronym
- FCP
- Status last verified
- Sep 2013
- First submitted
- 26 May 2008
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Extent of Diffusion Tensor Abnormalities in Focal Cortical Dysplasia
- ClinicalTrials.gov ID
- NCT00687024
- Acronym / sponsor ID
- FCP / 1000010634
- Conditions
- Focal Cortical Dysplasia, Epilepsy
- Keywords
- Epilepsy, Magnetic Resonance Imaging, Magnetoencephalography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 May 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.
Focal cortical dysplasia (FCD) is a common finding in epilepsy surgery in pediatric patients. Children with intractable epilepsy would have extensive tests to identify the cause of epilepsy; this includes MR brain, video EEG and magnetoencephalography (MEG). The white matter next to FCD is frequently found to be abnormal on pathology. Diffusion tensor imaging (DTI) can be used to study the abnormal white matter and the area that often extends beyond the area that is visible.
Detailed description
Focal cortical dysplasia (FCD) is a highly epileptogenic form of malformation of cortical development that may require surgical resection for epilepsy control. With abnormal development and organization of neurons within the cortex, the white matter projecting from the abnormal cortex is likely to be abnormal as well. The abnormality in the white matter involves not only the subcortical white matter, but also the long tracts in the deep white matter associated with the dysplastic cortex. Histologically, the subcortical white matter adjacent to the dysplastic cortex has been found to be abnormal. Studies using diffusion tensor imaging (DTI) to investigate the white matter adjacent to the MR visible abnormality have demonstrated reduced fractional anisotropy. However, electrographic abnormality in FCD often extends beyond the visible MR abnormality and surgical outcome of epilepsy surgery in FCD is dependent on excising the MR visible abnormality as well as electrographically abnormal area beyond the MR visible abnormality. The cortical and white matter abnormalities are therefore assumed to extend beyond the MR visible lesion. The short-term goal of this study is to determine whether quantitative measures of the abnormal white matter using DTI are able to provide surrogate markers for the extent of FCD. Whilst surgical outcome data is not available for the purpose of this study, these children will be followed up and in the longer term, the extent of FCD as determined by DTI will be compared with clinical outcome post surgery. This study will help determine the potential value of this technique in identifying areas of FCD that appear normal on structural MR. In the long term, this technique can be extended to study children with intractable epilepsy with (i) MR occult lesion and (ii) developmental tumor with MR occult FCD adjacent to the tumor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with suspected FCD presenting with intractable epilepsy for MRI \& MEG. The children will be identified from referral for clinical MRI scans.
Key inclusion criteria (1 listed)
- Children with intractable epilepsy with suspected FCD for MRI \& MEG
Key exclusion criteria (1 listed)
- Children with contraindications to MRI such as those with pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnetoencephalographyMEG will be performed on a whole head Omega 151-channel gradiometer system. At least 15 2-minute periods of spontaneous data are recorded. The sampling rate for data acquisition is 625Hz, with a bandpass filter of 3 to 70 Hz and a notch filter of 60Hz. | Procedure or surgery | – |
| MR imagingMR imaging will be performed on a GE 1.5T system using a variety of sequences, including sagittal T1, axial T2, axial FLAIR, coronal dual echo, coronal FLAIR, axial 3D T2 frFSE and axial SPGR. | Procedure or surgery | – |
| Diffusion Tensor ImagingDiffusion tensor imaging will be performed on the same scanner, using single shot diffusion-weighted echo planar imaging. Twenty-five 'xial contiguous slices are obtained aligned to the anterior commissure line to cover the whole brain, giving a total imaging time of 4min 40sec. | Procedure or surgery | – |
Primary outcome
Evaluate the subcortical white matter in the visualized MR abnormality as well as beyond the visualized MR abnormality but subjacent to the MEG dipoles
Time frame: Immediately after MEG
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 5 Sep 2013.
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Astroscape: A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II
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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.
Charles Raybaud, M.D. principal investigator
The Hospital for Sick Children
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 Focal Cortical Dysplasia and Epilepsy, run by The Hospital for Sick Children at 1 site in Canada.
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 1 inclusion and 1 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 5 Sep 2013. 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 Canada. 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?
Evaluate the subcortical white matter in the visualized MR abnormality as well as beyond the visualized MR abnormality but subjacent to the MEG dipoles (time frame: Immediately after MEG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2013.