Epilepsies, Partial Clinical Trial
Official title:
Contribution of Genetics, Non-invasive Neurophysiological Methods, Neuroimaging and Neuropsychology in Identifying the Cause and the Epileptogenic Zone in Focal Cryptogenic Epilepsies
Patients with cryptogenic focal epilepsy (unknown cause) represent about the 30% of the entire population of epilepsy patients. Among them, about 30% are drug-resistant. The implementation of of high-field magnetic resonance imaging resolution, the new Next Generation Sequencing techniques,and innovative non-invasive neurophysiological methods (Electroencephalogram-Functional magnetic resonance imaging and High Density-Electroencephalogram) could provide a superior identification of the epileptogenic zone and therefore an increased access to epilepsy surgery. Despite this, patients with cryptogenic epilepsy require more frequently invasive methods of presurgical study and they have more unfavorable results than patients with lesions detectable on magnetic resonance imaging. Within this context, the study is aimed at integrating the neurophysiological, radiological, neuropsychological and genetic aspects of patients with focal cryptogenic epilepsy in order to evaluate their surgical eligibility,sparing invasive methods.
The investigators foresee study duration of 36 months and the enrollment of about 20-25 patients, affected by cryptogenic epilepsy with onset during pediatric age (0-18 years), not only to identify the cause of epilepsy and the epileptogenic zone, but also to define in a non-invasive manner, the patient's possible eligibility for surgical therapy. Innovative neurophysiological methods, such as combined Electroencephalogram-Functional magnetic resonance imaging recording and high resolution electroencephalogram, in addition to 7 Tesla brain magnetic resonance imaging (available through the Imago7 non-profit foundation), neuropsychological studies and genetic tests through Next generation sequencing allow an advanced pre-surgical study free from the risks and discomforts caused by invasive methods. The systematic use of these diagnostic approaches will implement the knowledge and skills of the teams and it will stimulate their use in the clinical daily practise, especially for pediatric patients. In addition to that, the investigators would like to analyse descriptive indications relating to the diagnostic sensitivity of the combined Electroencephalogram-Functional magnetic resonance imaging recording, High Density-electroencephalogram and 7 Tesla magnetic resonance imaging in the identification of the epileptogenic zone, in patients with cryptogenic focal epilepsy. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00524030 -
Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
|
Phase 3 | |
| Completed |
NCT00143143 -
Pregabalin Open-Label Extension Trial in Patients With Partial Seizures
|
Phase 3 | |
| Completed |
NCT00771927 -
Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures
|
N/A | |
| Completed |
NCT00236873 -
A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.
|
Phase 2 | |
| Completed |
NCT01745952 -
Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)
|
N/A | |
| Completed |
NCT00772603 -
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
|
Phase 3 | |
| Completed |
NCT00280696 -
A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures
|
Phase 3 | |
| Completed |
NCT00643136 -
A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures
|
Phase 3 | |
| Completed |
NCT00230698 -
A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure
|
Phase 3 | |
| Completed |
NCT00072813 -
MRI in Autosomal Dominant Partial Epilepsy With Auditory Features
|
N/A | |
| Enrolling by invitation |
NCT04309812 -
Transcranial Direct Current to Treat Epilepsy at Home
|
Early Phase 1 | |
| Withdrawn |
NCT00422110 -
A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures
|
Phase 2/Phase 3 | |
| Completed |
NCT00620555 -
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
|
Phase 3 | |
| Completed |
NCT00448916 -
Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
|
Phase 3 | |
| Completed |
NCT00210522 -
An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy
|
Phase 2 | |
| Completed |
NCT00236886 -
Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients
|
Phase 3 | |
| Completed |
NCT00236860 -
A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures
|
Phase 2 | |
| Active, not recruiting |
NCT03689114 -
Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)
|
Phase 4 | |
| Completed |
NCT01098162 -
Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug
|
N/A | |
| Completed |
NCT05273398 -
Effects of Diazepam on RNS Detections
|
Phase 4 |