Focal Epilepsy With and Without Secondary GeneralizationPsychoSurgeryNCT06792383
Psychological and Psychiatric Assessment in Patients Eligible for Epilepsy Surgery
A study testing quality of life in people with Focal Epilepsy With and Without Secondary Generalization, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Epilepsy With and Without Secondary Generalization
- What is being tested?
- quality of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 2 Dec 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Foundation IRCCS Carlo Besta Neurological Institute
Milan, 20133
Rui Quintas, PsyD, 02 2394 ext. 2487, rui.quintas@istituto-besta.it
Marco de Curtis, MD, +39 02 2394 ext. 2487, rui.quintas@istituto-besta.it
About this study
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.
Read the 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.
- Being tested
- quality of life
- Keywords
- epilepsy, quality of life, psychiatric symptoms, stigma
- Medical subject headings
- Epilepsy, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of lifeDiagnostic test
Also called psychiatric symptoms
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 group | Role | What they receive |
|---|---|---|
| patients with drug-resistant focal epilepsy | Experimental | patients with drug-resistant focal epilepsy eligible for epilepsy surgery who will undergo the procedure immediately. Receives: Diagnostic Test: quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 years
Secondary outcomes (1)
Levels of quality of life
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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start2 Dec 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Focal Epilepsy With and Without Secondary GeneralizationStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco de Curtis, MD, Principal investigator, Clinical and Experimental Epileptology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via G. Celoria 11, 20133 Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792383
- Sponsor's protocol ID
- PsychoSurgery
- Acronym
- PsychoSurgery
- Status last verified
- Feb 2026
- First submitted
- 8 Jan 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26079497Locharernkul 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.
PubMed 16623030Devinsky 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.
PubMed 8348904Deleo 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.
PubMed 32512366Shneker BF, Fountain NB. Epilepsy. Dis Mon. 2003 Jul;49(7):426-78. doi: 10.1016/s0011-5029(03)00065-8.
PubMed 12838266Langfitt 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.
PubMed 17548548Spencer 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.
PubMed 17567854Tellez-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.
PubMed 17662062Luoni 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.
PubMed 22136077
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Psychiatric Assessment in Patients Eligible for Epilepsy Surgery
- ClinicalTrials.gov ID
- NCT06792383
- Acronym / sponsor ID
- PsychoSurgery / PsychoSurgery
- Keywords
- epilepsy, quality of life, psychiatric symptoms, stigma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| patients with drug-resistant focal epilepsy | Experimental | Diagnostic Test: quality of lifepatients with drug-resistant focal epilepsy eligible for epilepsy surgery who will undergo the procedure immediately. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of lifeAlso: psychiatric symptomsThe 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. | Diagnostic test | patients with drug-resistant focal epilepsy |
Primary outcome
Psychological characteristics
Time frame: 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
1 secondary outcome
Levels of quality of life
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 26079497Sawant 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.
- Background: PubMed 16623030Locharernkul 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.
- Background: PubMed 8348904Devinsky 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.
- Background: PubMed 32512366Deleo 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.
- Background: PubMed 12838266Shneker BF, Fountain NB. Epilepsy. Dis Mon. 2003 Jul;49(7):426-78. doi: 10.1016/s0011-5029(03)00065-8.
- Background: PubMed 17548548Langfitt 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.
- Background: PubMed 17567854Spencer 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.
- Background: PubMed 17662062Tellez-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.
- Background: PubMed 22136077Luoni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco de Curtis, MD principal investigator
Clinical and Experimental Epileptology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via G. Celoria 11, 20133 Milano, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quality of life in people with Focal Epilepsy With and Without Secondary Generalization, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Quintas, PsyD (+39 02 2394 ext. 2487, rui.quintas@istituto-besta.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological characteristics (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06792383, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.