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EpilepsyEpiBestaNCT06794606

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

An observational study of Epilepsy, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epilepsy
How many people
337 participants
Where
1 siteItaly
Study dates
23 Jun 2021to Mar 2041
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • Foundation IRCCS Carlo Besta Neurological Institute

    Milan, 20133

    Marco De Curtis, MD, + 39 02.2394 ext. 2242, marco.decurtis@istituto-besta.it

    Roberta Di Giacomo, MD, +39 02 2394 ext. 2242, roberta.digiacomo@istituto-besta.it

    Recruiting

Other trials in Italy

About this study

Official title: Multimodal Study for the Diagnosis and Treatment of Drug-resistant Focal Epilepsies

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.

Conditions
Epilepsy
Keywords
Epilepsy surgery, drugs resistant focal epilepsy
Medical subject headings
Epilepsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical Treatment

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

    Measured: 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.

    Measured: 10 years

Secondary outcomes (4)
  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

    Measured: 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

    Measured: 10 years

  3. Improving clinical outcomes

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

    Measured: 10 years

  4. Database

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

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2025
  2. Study start23 Jun 2021
  3. Primary completionMar 2041 (estimated)
  4. Study completionMar 2041 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
337 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06794606
Sponsor's protocol ID
EpiBesta
Acronym
EpiBesta
Status last verified
Mar 2026
First submitted
6 Dec 2024
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marco De Curtis, M.D. (02.2394.2242 ext. 2242, marco.decurtis@istituto-besta.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Treatment (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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