Localization-related EpilepsyNCT00894478
Improving Lesion Detection in Children With Magnetic Resonance Imaging (MRI)-Negative Partial Epilepsy Using Diffusion Tensor Imaging
An observational study of Localization-related Epilepsy and Partial Epilepsy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Focal cortical dysplasia is one of the most common lesions responsible for medically refractory epilepsy in the pediatric population. In patients with medically intractable epilepsy, surgery is the only treatment that will lead to seizure freedom. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Localization-related Epilepsy, Partial Epilepsy
- What is being tested?
- Diffusion Tensor Imaging (DTI) and Magnetoencephalography
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to May 2012
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients will be identified from the epilepsy clinic and seizure rounds and who have had previous MRI in an outside institution or prior MRI at least two years ago at the Hospital for Sick Children. Control children will be recruited through hospital publications and from families participating in the study (healthy siblings)
Who may be able to join
- MRI negative partial epilepsy group:
- Patients diagnosed with partial epilepsy according to the International League Against Epilepsy (ILAE) standard [53]
- MRI study reported as normal
- Age ranging from 6-18 years (DTI indices alter with myelination and the changes are most marked from birth to 4 years of age)
- MRI-visible FCD group:
- Patients diagnosed with partial epilepsy according to the ILAE standard [53]
Show all 17Show fewer
- Visual assessment of MRI demonstrates one or more features of FCD
- Cortical thickening
- Alteration in sulci and gyri pattern, including deep sulci
- Blurring of gray-white matter transition
- T2 signal prolongation of the cortex and subcortical white matter
- High T1 signal in the cortex
- Age ranging from 6-18 years (DTI indices alter with myelination and the changes are most marked from birth to 4 years of age)
- Normal controls:
- Subjects with no history of neurological diseases
- Age ranging from 6-18 years (most children under the age of 6 years are unable to tolerate the MR examination without general anesthesia or sedation).
- No requirement of general anesthesia or sedation
Who cannot join
- Subjects with contraindications for MR imaging (i.e. retained foreign bodies, implants)
- Subjects with claustrophobia
- Controls with a prior history of traumatic brain injury, neurological disorder, cerebral palsy, developmental delay or learning disability
- Controls who require general anesthesia or sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Lesion Detection in Children With MRI-negative Partial Epilepsy Using Diffusion Tensor Imaging
Focal cortical dysplasia is one of the most common lesions responsible for medically refractory epilepsy in the pediatric population. In patients with medically intractable epilepsy, surgery is the only treatment that will lead to seizure freedom. The outcome of epilepsy surgery is worse in patients when there is no lesion identified on routine structural MRI, also known as MRI-negative partial epilepsy. Diffusion tensor imaging (DTI), a novel MRI technique, can be used to evaluate the integrity of the microstructure of the white matter, even when the white matter appears normal on routine MRI.
Read the detailed description
The aims of this study are firstly to identify DTI abnormalities in the white matter of children with MRI-negative partial epilepsy and MRI-visible FCD compared to normal controls; and secondly to determine if the location of DTI identified abnormalities correlate with the epileptogenic zone as defined using magnetoencephalography (MEG) dipole clusters. Our hypotheses are firstly DTI can demonstrate the anatomic delineation of white matter abnormalities in MRI-negative partial epilepsy and the alteration in DTI indices are similar in MRI-negative partial epilepsy and MRI-visible FCD, which is the positive control; and secondly the anatomical location of DTI identified abnormalities correlate with the epileptogenic zone as defined by MEG dipole clusters. The long-term goal of this study is to improve detection of subtle lesions in children with MRI-negative partial epilepsy so as to improve the surgical outcome of these patients who undergo epilepsy surgery for seizure control.
- Conditions
- Localization-related Epilepsy, Partial Epilepsy
- Being tested
- Diffusion Tensor Imaging (DTI), Magnetoencephalography
- Keywords
- MRI-Negative, Diffusion tensor imaging, Localization-related epilepsy, Partial Epilepsy, Children
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Tensor Imaging (DTI)Procedure or surgery
MR and DTI: MRI and DTI will be done using 3.0T Philips MR scanner (Philips Medical Systems, Best, The Netherlands) using an eight channel head coil. DTI and axial 3D T1 will be performed on patients and controls.
- DTI will be performed using single shot diffusion-weighted echo planar imaging, b=1000s/mm2 and 15 noncollinear directions (TR/TE=10,000/60 ms, slice thickness=2mm, field of view=22cm, matrix=112x112, NEX=2)
- Axial 3D T1 (TR/TE=4.9/2.3 ms, slice thickness=1 mm, field of view = 24 cm, matrix=220x220, NEX=1) Patients will have additional sequences (axial and coronal T2, proton density and FLAIR) as part of their clinical scan
MagnetoencephalographyProcedure or surgery
Also called MEG
MEG will be performed using a whole-head Omega 151-channel gradiometer system (VSM MedTech, Port Coquitalam, BC, Canada). At least 15 2-minute periods of spontaneous data will be recorded with a sampling rate for data acquisition of 625Hz, a bandpass filter of 10 to 70 Hz and a notch filter of 60 Hz.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 12 children with MRI-negative partial epilepsy who are being worked-up for epilepsy surgery Receives: Procedure: Diffusion Tensor Imaging (DTI); Procedure: Magnetoencephalography | |
| 2 | 12 children with MRI-visible FCD who are being worked-up for epilepsy surgery Receives: Procedure: Diffusion Tensor Imaging (DTI); Procedure: Magnetoencephalography | |
| 3 | Control Group- Healthy Volunteers Receives: Procedure: Diffusion Tensor Imaging (DTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify DTI changes in the white matter of children with MRI-negative partial epilepsy and MRI-visible FCD using voxel-by-voxel analysis of FA and MD maps compared to normal controls.
Measured: 1 timepoint; immediately after MRI/DTI
Secondary outcomes (1)
Determine if the lobar location of abnormal FA and MD correlate with the lobar location of MEG defined epileptogenic zone in MRI-negative partial epilepsy and MRI-visible FCD.
Measured: 1 timepoint; immediately after MRI/DTI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localization-related EpilepsyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elysa Widjaja, The Hospital for Sick Children
- Investigators
- Elysa Widjaja, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894478
- Sponsor's protocol ID
- 1000013137
- Status last verified
- Sep 2013
- First submitted
- 6 May 2009
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Lesion Detection in Children With MRI-negative Partial Epilepsy Using Diffusion Tensor Imaging
- ClinicalTrials.gov ID
- NCT00894478
- Acronym / sponsor ID
- 1000013137
- Conditions
- Localization-related Epilepsy, Partial Epilepsy
- Keywords
- MRI-Negative, Diffusion tensor imaging, Localization-related epilepsy, Partial Epilepsy, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 May 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.
Focal cortical dysplasia is one of the most common lesions responsible for medically refractory epilepsy in the pediatric population. In patients with medically intractable epilepsy, surgery is the only treatment that will lead to seizure freedom. The outcome of epilepsy surgery is worse in patients when there is no lesion identified on routine structural MRI, also known as MRI-negative partial epilepsy. Diffusion tensor imaging (DTI), a novel MRI technique, can be used to evaluate the integrity of the microstructure of the white matter, even when the white matter appears normal on routine MRI.
Detailed description
The aims of this study are firstly to identify DTI abnormalities in the white matter of children with MRI-negative partial epilepsy and MRI-visible FCD compared to normal controls; and secondly to determine if the location of DTI identified abnormalities correlate with the epileptogenic zone as defined using magnetoencephalography (MEG) dipole clusters. Our hypotheses are firstly DTI can demonstrate the anatomic delineation of white matter abnormalities in MRI-negative partial epilepsy and the alteration in DTI indices are similar in MRI-negative partial epilepsy and MRI-visible FCD, which is the positive control; and secondly the anatomical location of DTI identified abnormalities correlate with the epileptogenic zone as defined by MEG dipole clusters. The long-term goal of this study is to improve detection of subtle lesions in children with MRI-negative partial epilepsy so as to improve the surgical outcome of these patients who undergo epilepsy surgery for seizure control.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Diffusion Tensor Imaging (DTI), Procedure: Magnetoencephalography12 children with MRI-negative partial epilepsy who are being worked-up for epilepsy surgery |
| 2 | – | Procedure: Diffusion Tensor Imaging (DTI), Procedure: Magnetoencephalography12 children with MRI-visible FCD who are being worked-up for epilepsy surgery |
| 3 | – | Procedure: Diffusion Tensor Imaging (DTI)Control Group- Healthy Volunteers |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients will be identified from the epilepsy clinic and seizure rounds and who have had previous MRI in an outside institution or prior MRI at least two years ago at the Hospital for Sick Children. Control children will be recruited through hospital publications and from families participating in the study (healthy siblings)
Key inclusion criteria (17 listed)
- Patients diagnosed with partial epilepsy according to the International League Against Epilepsy (ILAE) standard [53]
- MRI study reported as normal
- Age ranging from 6-18 years (DTI indices alter with myelination and the changes are most marked from birth to 4 years of age)
- Patients diagnosed with partial epilepsy according to the ILAE standard [53]
- Visual assessment of MRI demonstrates one or more features of FCD
Key exclusion criteria (4 listed)
- Subjects with contraindications for MR imaging (i.e. retained foreign bodies, implants)
- Subjects with claustrophobia
- Controls with a prior history of traumatic brain injury, neurological disorder, cerebral palsy, developmental delay or learning disability
- Controls who require general anesthesia or sedation
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 |
|---|---|---|
| Diffusion Tensor Imaging (DTI)MR and DTI: MRI and DTI will be done using 3.0T Philips MR scanner (Philips Medical Systems, Best, The Netherlands) using an eight channel head coil. DTI and axial 3D T1 will be performed on patients and controls. 1. DTI will be performed using single shot diffusion-weighted echo planar imaging, b=1000s/mm2 and 15 noncollinear directions (TR/TE=10,000/60 ms, slice thickness=2mm, field of view=22cm, matrix=112x112, NEX=2) 2. Axial 3D T1 (TR/TE=4.9/2.3 ms, slice thickness=1 mm, field of view = 24 cm, matrix=220x220, NEX=1) Patients will have additional sequences (axial and coronal T2, proton density and FLAIR) as part of their clinical scan | Procedure or surgery | 1, 2, 3 |
| MagnetoencephalographyAlso: MEGMEG will be performed using a whole-head Omega 151-channel gradiometer system (VSM MedTech, Port Coquitalam, BC, Canada). At least 15 2-minute periods of spontaneous data will be recorded with a sampling rate for data acquisition of 625Hz, a bandpass filter of 10 to 70 Hz and a notch filter of 60 Hz. | Procedure or surgery | 1, 2 |
Primary outcome
Identify DTI changes in the white matter of children with MRI-negative partial epilepsy and MRI-visible FCD using voxel-by-voxel analysis of FA and MD maps compared to normal controls.
Time frame: 1 timepoint; immediately after MRI/DTI
1 secondary outcome
Determine if the lobar location of abnormal FA and MD correlate with the lobar location of MEG defined epileptogenic zone in MRI-negative partial epilepsy and MRI-visible FCD.
Time frame: 1 timepoint; immediately after MRI/DTI
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 10 Sep 2013.
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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.
Elysa Widjaja, MD 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 Localization-related Epilepsy and Partial 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 17 inclusion and 4 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 10 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?
Identify DTI changes in the white matter of children with MRI-negative partial epilepsy and MRI-visible FCD using voxel-by-voxel analysis of FA and MD maps compared to normal controls. (time frame: 1 timepoint; immediately after MRI/DTI). 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 10 Sep 2013.