Diagnosis and treatment of drug-resistant focal epilepsies
Multimodal Study for the Diagnosis and Treatment of Drug-resistant Focal Epilepsies
This study is testing if surgery to remove the area of the brain causing seizures can help people with drug-resistant focal epilepsy feel better and have fewer seizures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 337 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06794606 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with drug-resistant focal epilepsy, a condition where seizures are not adequately controlled by medication. It aims to evaluate the effectiveness of surgical interventions, specifically the ablation of the epileptogenic zone, in improving patient outcomes. The study will involve careful selection of candidates based on their medical history and neuroimaging results. By analyzing the results of surgical treatment, the study seeks to provide insights into the potential for achieving seizure freedom in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients with a long history of drug-resistant focal seizures, either with identifiable epileptogenic lesions or cryptogenic cases.
Not a fit: Patients with uncertain epilepsy diagnoses or those with cognitive or psychiatric disorders that hinder their ability to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients suffering from drug-resistant focal epilepsy by offering a potential cure through surgical intervention.
How similar studies have performed: Previous studies have shown that surgical interventions can lead to significant improvements in seizure control for patients with drug-resistant epilepsy, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with focal epilepsy, long history of drug-resistant seizures, on mono- or polypharmacy antiepileptic therapy affected by known epileptogenic lesion or without lesions evident on neuroimaging investigations (cryptogenic). - - - Patients with recent onset of focal seizures, in mono- or polypharmacy, with controlled or rare seizures, or still in the absence of antiepileptic therapy affected by neoplastic lesion. Exclusion Criteria: * Patients in whom the diagnosis of epilepsy is doubtful. Patients with cognitive or psychiatric disorders that prevent participation in an interview, proper understanding of informed consent, or completion of questionnaires.
Where this trial is running
Milan
- Foundation IRCCS Carlo Besta Neurological Institute — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Marco De Curtis, M.D.
- Email: marco.decurtis@istituto-besta.it
- Phone: 02.2394.2242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.