Psychological and Psychiatric Assessment in Patients Eligible for Epilepsy Surgery (PsychoSurgery)

February 10, 2026 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
The aim of the study is to describe the socio-demographic, clinical, psychological, and psychiatric characteristics of patients with drug-resistant focal epilepsy eligible for epilepsy surgery and any changes in these parameters over time after surgery. Additionally, the study seeks to describe the levels of quality of life, dissociative experiences, prevalence of various psychiatric symptoms, irritability, depressive symptoms, anxiety symptoms, and stigma perception in patients with drug-resistant focal epilepsy eligible for epilepsy surgery and any changes over time after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to describe the socio-demographic, clinical, psychological, and psychiatric characteristics of patients with drug-resistant focal epilepsy eligible for epilepsy surgery and any changes in these parameters over time after surgery. Additionally, the study seeks to describe the levels of quality of life, dissociative experiences, prevalence of various psychiatric symptoms, irritability, depressive symptoms, anxiety symptoms, and stigma perception in patients with drug-resistant focal epilepsy eligible for epilepsy surgery and any changes over time after surgery.

This longitudinal, non-pharmacological interventional clinical study will be conducted at the Clinical and Experimental Epileptology Unit of the Institute. The enrollment will last for 24 months, during which approximately 30 patients with drug-resistant focal epilepsy eligible for epilepsy surgery will be enrolled, from both genders, aged at least 18 years.

Two groups of patients eligible for epilepsy surgery will be enrolled:

  • Study group: patients with drug-resistant focal epilepsy eligible for epilepsy surgery who will undergo the procedure immediately.
  • Control group: patients with drug-resistant focal epilepsy eligible for epilepsy surgery who, due to the need for further investigations and evaluations, will undergo the surgery at least 1 year after the baseline.

For the study group, data will be collected at three time points:

  • At the time of pre-surgical hospitalization (baseline)
  • 6 months after epilepsy surgery, during the first post-surgical follow-up visit (FU1)
  • 12 months after epilepsy surgery, during the second post-surgical follow-up visit (FU2)

For the control group, data will be collected at three time points as well:

  • At the time of surgical indication (baseline)
  • 6 months after baseline and before epilepsy surgery (FU1)
  • 12 months after baseline and before epilepsy surgery (FU2) At all three data collection time points, clinical psychological interviews and the administration of questionnaires evaluating the study variables will be conducted for both groups.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • Foundation IRCCS Carlo Besta Neurological Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rui Quintas, PsyD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 or older at the time of enrollment;
  • Patients with drug-resistant focal epilepsy followed at the Institute for at least 6 months;
  • Patients with drug-resistant focal epilepsy eligible for epilepsy surgery;
  • Patients capable of providing informed consent to participate in the study and for the processing of personal data.

Exclusion Criteria:

  • Patients with evident and/or diagnosed cognitive or psychiatric disorders that prevent participation in an interview, proper understanding of informed consent, or completion of questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with drug-resistant focal epilepsy
patients with drug-resistant focal epilepsy eligible for epilepsy surgery who will undergo the procedure immediately.
Diagnostic test: quality of life

The following assessment tools will be proposed to patients:

  • Quality of Life in Epilepsy (QOLIE-31)26
  • Dissociative Experience Scale (DES)27
  • Symptom Checklist-90 (SCL-90)28
  • Irritability Questionnaire (I-EPI)29
  • Beck Depression Inventory II (BDI-II)30
  • State-Trait Anxiety Inventory Y-1 e Y-2 (STAI)31
  • Epilepsy Stigma Scale modificata32 These assessment tools are validated and used universally, and will allow the collection of information on the psychological and psychiatric functioning of the patients.
Other Names:
  • psychiatric symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological characteristics
Time Frame: 6 years
Description of the time course of the clinical, psychological, and psychiatric characteristics of patients with drug-resistant focal epilepsy eligible for epilepsy surgery
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of quality of life
Time Frame: 6 years
Description of the time course of the levels of quality of life, dissociative experiences, prevalence of various psychiatric symptoms, levels of irritability, depressive symptoms, anxiety symptoms, and stigma perception in patients with drug-resistant focal epilepsy eligible for immediate epilepsy surgery.
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Investigators

  • Principal Investigator: Marco de Curtis, MD, Clinical and Experimental Epileptology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via G. Celoria 11, 20133 Milano, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PsychoSurgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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