Psychological and Psychiatric Assessment in Patients Eligible for Epilepsy Surgery

NCT06792383 | Recruiting

• 1 other identifier: PsychoSurgery
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Focal Epilepsy With and Without Secondary Generalization

Keywords

epilepsy; quality of life; psychiatric symptoms; stigma

Outcome Measures

Primary Outcomes (1)

• Psychological characteristics

  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 Outcomes (1)

• Levels of quality of life

  6 years

Study Arms (1)

patients with drug-resistant focal epilepsy

EXPERIMENTAL

patients with drug-resistant focal epilepsy eligible for epilepsy surgery who will undergo the procedure immediately.

Diagnostic Test: quality of life

Interventions

quality of life DIAGNOSTIC_TEST

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.

Also known as: psychiatric symptoms

patients with drug-resistant focal epilepsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Foundation IRCCS Carlo Besta Neurological Institute

Milan, 20133, Italy

RECRUITING

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Shneker BF, Fountain NB. Epilepsy. Dis Mon. 2003 Jul;49(7):426-78. doi: 10.1016/s0011-5029(03)00065-8.

  PMID: 12838266 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Luoni C, Bisulli F, Canevini MP, De Sarro G, Fattore C, Galimberti CA, Gatti G, La Neve A, Muscas G, Specchio LM, Striano S, Perucca E; SOPHIE Study Group. Determinants of health-related quality of life in pharmacoresistant epilepsy: results from a large multicenter study of consecutively enrolled patients using validated quantitative assessments. Epilepsia. 2011 Dec;52(12):2181-91. doi: 10.1111/j.1528-1167.2011.03325.x.

  PMID: 22136077 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Social Stigma

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Social Behavior; Behavior

Study Officials

• Marco de Curtis, MD

  Clinical and Experimental Epileptology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via G. Celoria 11, 20133 Milano, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Quintas, PsyD

CONTACT

+39 02 2394; rui.quintas@istituto-besta.it

Marco de Curtis, MD

CONTACT

+39 02 2394; rui.quintas@istituto-besta.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 24, 2025
• Study Start: December 2, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)