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RecruitingNCT06794606EpiBestaUpdated Apr 1, 2026

Study for the Diagnosis and Treatment of Drug-resistant Focal Epilepsies

An observational study in Epilepsy, sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Observational

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 3 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
337
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Epilepsy

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Keywords

  • Epilepsy surgery
  • drugs resistant focal epilepsy
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In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 337 is above the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta is the lead sponsor of 83 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
337 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Surgical Treatment

    To assess the clinical-epileptological course of patients with focal epilepsy who are candidates for surgical treatment of epilepsies

    Time frame: 10 years

  2. Alternative to resective surgery

    To assess the clinical-epileptological course of patients with focal epilepsy who are candidates for diagnostic and therapeutic interventions as an alternative to conventional resective surgery.

    Time frame: 10 years

Secondary outcomes

  1. Investigate the factors

    To investigate the factors (environmental/molecular/genetic) leading to the development of epilepsies, in particular the forms resistant to pharmacological treatment

    Time frame: 10 years

  2. Identify new approaches

    To identify new and more effective non-invasive approaches in order to precisely identify the surgical target (epileptogenic zone) reducing the use of invasive monitoring and treatment techniques

    Time frame: 10 years

  3. Improving clinical outcomes

    Improving clinical outcomes by reducing costs and risks associated with diagnostic and therapeutic procedures in epilepsy surgery

    Time frame: 10 years

  4. Database

    Structuring a database of patients with drug-resistant focal epilepsy for future treatment

    Time frame: 10 years

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06794606
Lead sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Responsible party
Sponsor
First posted
Jan 27, 2025
Start date
Jun 23, 2021
Primary completion
Mar 2041 (estimated)
Completion
Mar 2041 (estimated)
Last update
Apr 1, 2026

Study contacts

Marco De Curtis, M.D.
Contact
marco.decurtis@istituto-besta.it
02.2394.2242 ext. 2242
Roberta Di Giacomo, M.D.
Contact
roberta.digiacomo@istituto-besta.it
02.2394.2242 ext. 2242

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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