Psychological and Psychiatric Assessment in Patients Eligible for Epilepsy Surgery

Not Applicable

Recruiting

• Conditions: Focal Epilepsy with and Without Secondary Generalization

• Registration Number: NCT06792383
• Lead Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Brief Summary

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.

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 Timeline

• Study Start: 2020-12-02
• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Psychological characteristics	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

Secondary Outcome Measures

Name	Time	Method
Levels of quality of life	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.

Trial Locations

Locations (1)

Foundation IRCCS Carlo Besta Neurological Institute; 🇮🇹 Milano, Italy