NCT06794606 Study for the Diagnosis and Treatment of Drug-resistant Focal Epilepsies
| NCT ID | NCT06794606 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Condition | Epilepsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 337 participants |
| Start Date | 2021-06-23 |
| Primary Completion | 2041-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 337 participants in total. It began in 2021-06-23 with a primary completion date of 2041-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Epilepsy is a clinical condition that affects about fifty million people worldwide, with an estimated occurrence of 16-51 new cases per 100,000 people each year. In 60% of these patients, the origin of seizures is due to a localized (focal) alteration of the brain. In about 25 percent of patients with focal epilepsy, drug treatment is ineffective, a condition defined by the International League Against Epilepsy (ILAE) as drug-resistant epilepsy ; this condition results in a drastic reduction in quality of life associated with psychosocial dysfunction and an increased risk of sudden death. A possible treatment alternative for drug-resistant patients is ablation of the epileptogenic zone through surgical methods that are effective and safe when patients are carefully selected. The percentage of patients with epilepsy who are completely cured after surgery is about 70% for temporal lobe epilepsies, and can be as high as 90% in the case of some brain malformations. Pre-surgical screening and therapeutic intervention (particularly surgery) have health care costs that are amortized over 2-6 years depending on the procedures required before surgery. In the last decade, moreover, the refinement of noninvasive/mini-invasive methods such as radiosurgery, Magnetic Resonance-guided Focused Ultrasound (MRgFUS) and laser interstitial thermal therapy (LiTT) have allowed us to hypothesize a possible specific treatment of drug-resistant patients with epileptogenic areas that are difficult to reach with traditional surgery and patients with complex comorbidities for whom the risks of standard resective surgery would outweigh the possible benefits. Finally, there is a subgroup of patients with drug-resistant epilepsy who cannot undergo ablative surgery. In these patients, seizures originate from multiple areas of the brain (multifocal epilepsy) or the epileptogenic area affects functionally eloquent areas. In these cases, alternative functional treatments are proposed, which aim to decrease the frequency and intensity of seizures and the need for medication, such as: i) application of a vagal stimulator, a pulse generator that is implanted in the chest and connected to the vagus nerve, ii) implantation of deep brain stimulation devices, iii) neuromodulation. Therefore, careful selection of patients during the diagnostic/pre-surgical process is crucial. The multimodal assessments under study, proposed in support of clinical practice, aim to improve such selection by analyzing the causative factors of seizures, the location of the epileptogenic zone, and the clinical-epileptological course of patients who are candidates for surgical or functional treatment of epilepsies.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06794606 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06794606 currently recruiting?
Yes, NCT06794606 is actively recruiting participants. Contact the research team at marco.decurtis@istituto-besta.it for enrollment information.
Where is the NCT06794606 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06794606 clinical trial?
NCT06794606 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The trial plans to enroll 337 participants.
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