- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03268824
Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain (EPITRACT)
Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain: Combination of Intracerebral Stereotactic Electroencephalography Recording and Diffusion Tensor Imaging in Children With Drug-resistant Focal Epilepsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Drug-resistant focal epilepsy is a debilitating disease as it is often accompanied by learning disabilities and behavioral disorders, that can be present at the disease onset and have ample repercussions on the child's quality of life.
Despite a focal onset of seizures, the dysfunction of the cerebral networks is diffuse. Structural brain connectivity can be measured with diffusion tractography, which has shown evidence of widespread network pathology in focal epilepsy, probably explaining the associated learning disabilities. Whether ongoing seizure activity further modifies network wiring and possibly generates abnormal pathways along the routes of seizure propagation is a matter of debate.
The study intends to probe the effect of seizures on cerebral connectivity, both on a local and on a global level. Children who undergo presurgical evaluation to probe whether their epilepsy can be cured by surgery are recorded with implanted intracerebral electrodes for clinical purposes. A diffusion Magnetic Resonance Imaging will be performed prior to implantation in order to relate tractography measures to seizure recordings. On the local level, intracerebral electroencephalogram (EEG) will be analysed to quantify the intensity of epileptic discharge (the epileptogenicity index) on each electrode contact. Loss of connectivity (or disconnections) is determined with diffusion tractography for each brain region. Then correlation between the degree of epileptogenicity and with the number of disconnections will be studied.
On a global level, the study will quantify all white matter fibers within the language area (Broca's) in the left and the corresponding area in the right hemisphere. The difference between hemispheres yields us the lateralization index. The secondary outcome probes whether children with focal epilepsy have atypical language organization, as a measure of diffuse changes in brain wiring.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Vera Dinkelacker, MD PhD
- Phone Number: +33 0148036853
- Email: vdinkelacker@for.paris
Study Locations
-
-
-
Paris, France
- Recruiting
- Fondation Ophtalmologique A. de Rothschild
-
Contact:
- Vera Dinkelacker, MD PhD
- Phone Number: +33 0148036853
- Email: vdinkelacker@for.paris
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Drug resistant focal epilepsy
Inclusion Criteria for control patients:
- without drug resistant focal epilepsy
Exclusion Criteria:
- Severe mental retardation (IQ < 50)
- Lack of French-language skills
- Contraindications to MRI
- Bi-hemispherical epilepsy or affecting multiple lobes
Exclusion Criteria for control patients:
- Severe mental retardation (IQ < 50)
- Lack of French-language skills
- Contraindications to MRI
- Congenital pathology altering cerebral connectivity
- Parenchymal brain lesions
- Unilateral or bilateral blindness
- Unilateral or bilateral deafness
- Autistic disorders
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children / adolescents with drug-resistant focal epilepsy
|
Intracerebral electroencephalogram (EEG) will be analysed to quantify the intensity of epileptic discharge (the epileptogenicity index) on each electrode contact (only for children with focal epilepsy).
We will perform Diffusion Tensor imaging in order to relate tractography measures to seizure recordings.
Loss of connectivity (or disconnections) will be determined with diffusion tractography for each brain region.
Then we will correlate the degree of epileptogenicity with the number of disconnections.
The language assessment will be adapted to the age of the child, with a predominant neuropsychological component.
|
Children / adolescents without drug-resistant focal epilepsy
|
We will perform Diffusion Tensor imaging in order to relate tractography measures to seizure recordings.
Loss of connectivity (or disconnections) will be determined with diffusion tractography for each brain region.
Then we will correlate the degree of epileptogenicity with the number of disconnections.
The language assessment will be adapted to the age of the child, with a predominant neuropsychological component.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between the number of cerebral disconnections and the epileptogenicity index
Time Frame: Baseline
|
The epileptogenicity index is based on measurement of the intensity of rapid frequency discharges in relation to the cerebral activity outside the seizures.
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vera Dinkelacker, MD PhD, Fondation Ophtalmologique A. de Rothschild
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VDR_2017_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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