Clinical trial NCT06794606: Study for the Diagnosis and Treatment of Drug-resistant Focal Epilepsies
Official title: Multimodal Study for the Diagnosis and Treatment of Drug-resistant Focal Epilepsies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Keywords: Epilepsy surgery
drugs resistant focal epilepsy
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Primary outcomes:
measure: Surgical Treatment
timeFrame: 10 years
measure: Alternative to resective surgery
timeFrame: 10 years
Secondary outcomes:
measure: Investigate the factors
timeFrame: 10 years
measure: Identify new approaches
timeFrame: 10 years
measure: Improving clinical outcomes
timeFrame: 10 years
measure: Database
timeFrame: 10 years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Foundation IRCCS Carlo Besta Neurological Institute
Study officials:
References: