Assessing psychological and psychiatric factors in epilepsy surgery candidates
Psychological and Psychiatric Assessment in Patients Eligible for Epilepsy Surgery
NA · Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · NCT06792383
This study looks at how surgery for drug-resistant epilepsy affects the mental health and quality of life of patients, comparing those who have surgery right away with those who wait.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT06792383 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the socio-demographic, clinical, psychological, and psychiatric characteristics of patients with drug-resistant focal epilepsy who are eligible for surgery. It will track changes in these parameters over time, focusing on quality of life, psychiatric symptoms, and stigma perception. The study will involve two groups: one undergoing surgery immediately and another waiting for further evaluations. Data will be collected at multiple time points to assess the impact of surgery on these factors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with drug-resistant focal epilepsy who are eligible for epilepsy surgery.
Not a fit: Patients with significant cognitive or psychiatric disorders that hinder their ability to participate in assessments will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the psychological aspects of epilepsy surgery, potentially improving patient outcomes and quality of life.
How similar studies have performed: While there have been studies on epilepsy surgery outcomes, this specific focus on psychological and psychiatric assessments in a longitudinal framework is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan
- Foundation IRCCS Carlo Besta Neurological Institute — Milan, Italy (RECRUITING)
Study contacts
- Principal investigator: Marco de Curtis, MD — Clinical and Experimental Epileptology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via G. Celoria 11, 20133 Milano, Italy
- Study coordinator: Rui Quintas, PsyD
- Email: rui.quintas@istituto-besta.it
- Phone: +39 02 2394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Focal Epilepsy With and Without Secondary Generalization, epilepsy, quality of life, psychiatric symptoms, stigma