Psychological and Psychiatric Assessment in Patients Eligible for Epilepsy Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: quality of life.
- Who it may be relevant to
- Registry conditions: Focal Epilepsy With and Without Secondary Generalization. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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
Primary outcome measures
- Psychological characteristics [Time frame: 6 years]
Secondary outcome measures (1)
- Levels of quality of life [Time frame: 6 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- Foundation IRCCS Carlo Besta Neurological Institute — Milan
Publications
- Sawant N, Ravat S, Muzumdar D, Shah U. Is psychiatric assessment essential for better epilepsy surgery outcomes? Int J Surg. 2016 Dec;36(Pt B):460-465. doi: 10.1016/j.ijsu.2015.06.025. Epub 2015 Jun 12. PMID 26079497
- Locharernkul C, Kanchanatawan B, Bunyaratavej K, Srikijvilaikul T, Deesudchit T, Tepmongkol S, Lertlum S, Tuchinda L, Shoungshotti C, Ounpak P. Quality of life after successful epilepsy surgery: evaluation by occupational achievement and income acquisition. J Med Assoc Thai. 2005 Sep;88 Suppl 4:S207-13. PMID 16623030
- Devinsky O, Penry JK. Quality of life in epilepsy: the clinician's view. Epilepsia. 1993;34 Suppl 4:S4-7. doi: 10.1111/j.1528-1157.1993.tb05916.x. PMID 8348904
- Deleo F, Quintas R, Pastori C, Pappalardo I, Didato G, Di Giacomo R, de Curtis M, Villani F. Quality of life, psychiatric symptoms, and stigma perception in three groups of persons with epilepsy. Epilepsy Behav. 2020 Sep;110:107170. doi: 10.1016/j.yebeh.2020.107170. Epub 2020 Jun 5. PMID 32512366
- Shneker BF, Fountain NB. Epilepsy. Dis Mon. 2003 Jul;49(7):426-78. doi: 10.1016/s0011-5029(03)00065-8. PMID 12838266
- Langfitt JT, Westerveld M, Hamberger MJ, Walczak TS, Cicchetti DV, Berg AT, Vickrey BG, Barr WB, Sperling MR, Masur D, Spencer SS. Worsening of quality of life after epilepsy surgery: effect of seizures and memory decline. Neurology. 2007 Jun 5;68(23):1988-94. doi: 10.1212/01.wnl.0000264000.11511.30. PMID 17548548
- Spencer SS, Berg AT, Vickrey BG, Sperling MR, Bazil CW, Haut S, Langfitt JT, Walczak TS, Devinsky O; Multicenter Study of Epilepsy Surgery. Health-related quality of life over time since resective epilepsy surgery. Ann Neurol. 2007 Oct;62(4):327-34. doi: 10.1002/ana.21131. PMID 17567854
- Tellez-Zenteno JF, Patten SB, Jette N, Williams J, Wiebe S. Psychiatric comorbidity in epilepsy: a population-based analysis. Epilepsia. 2007 Dec;48(12):2336-44. doi: 10.1111/j.1528-1167.2007.01222.x. Epub 2007 Jul 28. PMID 17662062
Identifiers
NCT: NCT06792383 · PsychoSurgery