Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03268824
Study type Observational
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact Laurence Salomon, MD PhD
Phone 0148036431
Email lsalomon@for.paris
Status Recruiting
Phase
Start date December 19, 2017
Completion date October 2024

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05975658 - WIReD: Wireless Interstage Remote Device Study
Completed NCT03921346 - Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR N/A
Not yet recruiting NCT04087070 - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Completed NCT04301206 - Videos and Simple Text to Empower Parents to Handle Their Sick Children N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Recruiting NCT05480930 - Improving Nighttime Access to Care and Treatment; Part 4-Haiti N/A
Not yet recruiting NCT05815563 - Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block in Pediatrics
Recruiting NCT02908113 - Visual Perception in Preterm Infants N/A
Recruiting NCT02556541 - Ultrasound-guided Peripheral Vascular Access in Children N/A
Not yet recruiting NCT01678066 - A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor N/A
Completed NCT04993599 - Evaluation of Social Robot Usability for Pediatric Patients and Carers N/A
Completed NCT05537168 - Bayesian Networks in Pediatric Cardiac Surgery
Completed NCT01603628 - BOTOX® Treatment in Pediatric Lower Limb Spasticity Phase 3
Completed NCT01603615 - BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity Phase 3
Completed NCT06098105 - Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics N/A
Completed NCT01418846 - Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients N/A
Completed NCT01460329 - Comparing Cardiac Output Measurements in Critically Ill Children Using USCOM and Transthoracic ECHO N/A
Withdrawn NCT00666393 - An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients Phase 3
Recruiting NCT03337581 - Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric Phase 4
Recruiting NCT05275881 - Impact of Virtual Reality in Pediatric Hematology and Oncology N/A