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NCT Number: NCT06792383

Psychological and Psychiatric Assessment in Patients Eligible for Epilepsy Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation IRCCS Carlo Besta Neurological Institute

Milan, 20133, Italy

Location status: Recruiting

Location contact

Marco de Curtis, MD

CONTACT

[email protected]

+39 02 2394 ext. 2487

Rui Quintas, PsyD

CONTACT

[email protected]

02 2394 ext. 2487

Rui Quintas, PsyD

PRINCIPAL_INVESTIGATOR

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: psychiatric symptoms

Primary outcomes

  1. 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

Secondary outcomes

  1. Levels of quality of life

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marco de Curtis, MD

CONTACT

[email protected]

+39 02 2394 ext. 2487

Rui Quintas, PsyD

CONTACT

[email protected]

+39 02 2394 ext. 2487

Sponsors and collaborators

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Other

Registry information

Acronym: PsychoSurgery

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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