Epilepsies, FocalEPITRACTNCT03268824
Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain
An observational study of Epilepsies, Focal and Pediatrics, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Focal epilepsy is associated with widespread alterations in structural brain connectivity, often present at the disease onset and related to learning disabilities. Whether ongoing seizure activity contributes to network pathology is a matter of debate. Read more about this study
- Who is it for?
- Ages 18 months to 16 years
- Conditions the study is for
- Epilepsies, Focal, Pediatrics, Drug Resistant Epilepsy
- What is being tested?
- Electroencephalogram (EEG), Diffusion Tensor imaging and Language assessment
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2017to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 months to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children/adolescents with drug resistant focal epilepsy.
Who may be able to join
- Drug resistant focal epilepsy
- without drug resistant focal epilepsy
Who cannot join
- Severe mental retardation (IQ < 50)
- Lack of French-language skills
- Contraindications to MRI
- Bi-hemispherical epilepsy or affecting multiple lobes
- Severe mental retardation (IQ < 50)
- Lack of French-language skills
Show all 12Show fewer
- Contraindications to MRI
- Congenital pathology altering cerebral connectivity
- Parenchymal brain lesions
- Unilateral or bilateral blindness
- Unilateral or bilateral deafness
- Autistic disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation Ophtalmologique A. de Rothschild
Paris
Vera Dinkelacker, MD PhD, 0148036853 ext. +33, vdinkelacker@for.paris
About this study
Official title: 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
Focal epilepsy is associated with widespread alterations in structural brain connectivity, often present at the disease onset and related to learning disabilities. Whether ongoing seizure activity contributes to network pathology is a matter of debate. This study intends to measure the impact of seizures on structural connectivity on a local and on a global level. In children examined with intracerebral electrodes to evaluate whether a surgical cure can be proposed, we combine intracerebral stereotactic electroencephalography (EEG) recordings with diffusion weighted imaging of white matter fibers. On the local level, the study will quantify the number of deficient connections in the seizure onset zone. On a global level, the study will compare the white matter fibers of the left and right hemisphere to probe whether physiological language lateralization is preserved.
Read the 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.
- Conditions
- Epilepsies, Focal, Pediatrics, Drug Resistant Epilepsy
- Being tested
- Electroencephalogram (EEG), Diffusion Tensor imaging, Language assessment
- Medical subject headings
- Epilepsies, Partial, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalogram (EEG)Device
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).
Diffusion Tensor imagingDevice
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.
Language assessmentOther
The language assessment will be adapted to the age of the child, with a predominant neuropsychological component.
| Study group | Role | What they receive |
|---|---|---|
| Children / adolescents with drug-resistant focal epilepsy | Not described Receives: Device: Electroencephalogram (EEG); Device: Diffusion Tensor imaging; Other: Language assessment | |
| Children / adolescents without drug-resistant focal epilepsy | Not described Receives: Device: Diffusion Tensor imaging; Other: Language assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the number of cerebral disconnections and the epileptogenicity index
The epileptogenicity index is based on measurement of the intensity of rapid frequency discharges in relation to the cerebral activity outside the seizures.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start19 Dec 2017
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsies, FocalStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Vera Dinkelacker, MD PhD, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268824
- Sponsor's protocol ID
- VDR_2017_1
- Acronym
- EPITRACT
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2017
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03268824
- Acronym / sponsor ID
- EPITRACT / VDR_2017_1
- Conditions
- Epilepsies, Focal, Pediatrics, Drug Resistant Epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 Aug 2017 (actual)
- 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 epilepsy is associated with widespread alterations in structural brain connectivity, often present at the disease onset and related to learning disabilities. Whether ongoing seizure activity contributes to network pathology is a matter of debate. This study intends to measure the impact of seizures on structural connectivity on a local and on a global level. In children examined with intracerebral electrodes to evaluate whether a surgical cure can be proposed, we combine intracerebral stereotactic electroencephalography (EEG) recordings with diffusion weighted imaging of white matter fibers. On the local level, the study will quantify the number of deficient connections in the seizure onset zone. On a global level, the study will compare the white matter fibers of the left and right hemisphere to probe whether physiological language lateralization is preserved.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children / adolescents with drug-resistant focal epilepsy | – | Device: Electroencephalogram (EEG), Device: Diffusion Tensor imaging, Other: Language assessment |
| Children / adolescents without drug-resistant focal epilepsy | – | Device: Diffusion Tensor imaging, Other: Language assessment |
Who may qualify
- Ages
- 18 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children/adolescents with drug resistant focal epilepsy.
Key inclusion criteria (2 listed)
- Drug resistant focal epilepsy
- without drug resistant focal epilepsy
Key exclusion criteria (12 listed)
- Severe mental retardation (IQ < 50)
- Lack of French-language skills
- Contraindications to MRI
- Bi-hemispherical epilepsy or affecting multiple lobes
- Severe mental retardation (IQ < 50)
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 |
|---|---|---|
| Electroencephalogram (EEG)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). | Device | Children / adolescents with drug-resistant focal epilepsy |
| Diffusion Tensor imagingWe 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. | Device | Children / adolescents with drug-resistant focal epilepsy, Children / adolescents without drug-resistant focal epilepsy |
| Language assessmentThe language assessment will be adapted to the age of the child, with a predominant neuropsychological component. | Other | Children / adolescents with drug-resistant focal epilepsy, Children / adolescents without drug-resistant focal epilepsy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Vera Dinkelacker, MD PhD principal investigator
Fondation Ophtalmologique A. de Rothschild
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 Epilepsies, Focal and Pediatrics, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 2 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence Salomon, MD PhD (0148036431 ext. +33, lsalomon@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the number of cerebral disconnections and the epileptogenicity index (time frame: Baseline). 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 Jan 2026.