Focal Epilepsy With and Without Secondary Generalization
Conditions
Keywords
epilepsy, quality of life, psychiatric symptoms, stigma
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.
Interventions
DIAGNOSTIC_TESTquality 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.
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
CONTACTRui Quintas, PsyD
CONTACTMarco de Curtis, MD
PRINCIPAL_INVESTIGATORMarco de Curtis, MD
Clinical and Experimental Epileptology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via G. Celoria 11, 20133 Milano, Italy
Outcome results
None listed