NCT06792383

Psychological and Psychiatric Assessment in Patients Eligible for Epilepsy Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Focal Epilepsy With and Without Secondary Generalization

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-01-24
• Last updated: 2026-02-12

Locations

1 site across 1 country: Italy