Anxiety Disorders, Drug Restistant Epilepsie, Epilepsies, Focal, Post-traumatic Stress Disorder (PTSD)
Conditions
Keywords
Epilepsy surgery, Drug-resistant focal epilepsy, Post-traumatic stress disorder, Surgical outcomes, Advanced practice nursing
Brief summary
Why is this study being conducted? For people with drug-resistant focal epilepsy, surgery, to remove the part of the brain where seizures start, is currently the most effective treatment. In many people, especially those with temporal lobe epilepsy, surgery can stop seizures completely and improve quality of life. However, doctors usually predict the chances of surgical success using brain scans and other neurological tests, while the possible influence of psychological and social factors remains less well understood. Mental health is an important part of overall health. People living with epilepsy are more likely than the general population to experience anxiety, depression, and post-traumatic stress disorder (PTSD). PTSD can develop after experiencing traumatic events and may affect emotional well-being, daily activities, relationships, and physical health. Some studies suggest that PTSD may affect brain networks involved in epilepsy. This raises an important question: could PTSD influence the success of epilepsy surgery? We hypothesize that PTSD and other psychological or social factors may affect surgical outcomes and recovery after surgery. At present, there is limited evidence available to answer this question. What is the aim of the study? The main objective of this study is to determine whether PTSD affects the success of epilepsy surgery two years after the operation. The study also aims to: * Describe the medical, psychological, and social characteristics of people undergoing epilepsy surgery and estimate how common traumatic experiences and PTSD are in this population; * Assess changes in PTSD symptoms, anxiety, depression, quality of life, social vulnerability, and patient satisfaction before and after surgery; * Identify biological, psychological, and social factors associated with successful surgical outcomes. Rather than focusing only on seizure control, this study aims to improve understanding of the factors that contribute to recovery, quality of life, and long-term well-being after epilepsy surgery. The findings may help healthcare professionals provide more personalized support before and after surgery. Who can take part? Between September 2026 and September 2028, the study will recruit 42 adults with drug-resistant focal epilepsy who are being evaluated for resective epilepsy surgery at Timone University Hospital in Marseille, France. What does participation involve? Participants will join the study approximately three months before surgery and will be followed for two years after the operation. During routine pre-operative and post-operative follow-up visits, participants will complete validated self-report questionnaires about: * Traumatic experiences and PTSD symptoms; * Anxiety and depression; * Quality of life; * Social vulnerability; * Satisfaction with surgery. Participants whose questionnaire results suggest possible PTSD will be offered a routine psychiatric assessment to confirm the diagnosis. Based on these assessments, participants will be classified into one of two groups: people with PTSD and people without PTSD. The study will also use clinical information routinely collected as part of epilepsy care, including brain imaging, electroencephalography (EEG), and neuropsychological assessments. What are the expected benefits of this research? This study may improve understanding of how psychological and social factors influence epilepsy surgery outcomes. The results may help healthcare professionals better identify patients who could benefit from additional support before and after surgery. In the future, the findings could contribute to the development of more personalized care pathways, including advanced practice nursing follow-up, improved mental health screening, and targeted support to enhance seizure outcomes, quality of life, emotional well-being, and patient satisfaction after epilepsy surgery
Interventions
OTHERBaseline PTSD status
The exposure of interest is the presence or absence of post-traumatic stress disorder (PTSD) before epilepsy surgery. During the preoperative assessment, participants will complete the PTSD Checklist for DSM-5 (PCL-5).
This intervention consists in the completion of diverse questionnaires assessing the quality of life of the subject. These questionnaires include: - quality of life questionnaires: QOLIE-31 - psychiatric questionnaires CTQ-SF, LEC-5, PCL-5, PTSD-E, GAD-7, NDDI-E, EPICES, , ESSQ-19. These questionnaires will be performed 3 months before surgery and at 1, 3, 12 and 24 months after surgery using validated French-language instruments.
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older * Individuals informed about the study who do not object to participation * Individuals with drug-resistant focal epilepsy (failure of at least two appropriately selected and adequately administered anti-seizure medications) * Eligible for resective epilepsy surgery and awaiting surgery * Covered by the French health insurance system
Exclusion criteria
* Concurrent participation in another research study that precludes enrollment * Individuals unable to provide informed participation according to French regulations, covered by Articles L1121-5 to L1121-8 of the French Public Health Code * Individuals who do not understand French * Individuals with generalized epilepsy * Individuals whose epilepsy is controlled with anti-seizure medication * Contraindication to resective epilepsy surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical success at 24 months after epilepsy surgery | 24 months post-surgery | Proportion of participants classified as Engel Class IA (seizure-free) versus non-IA at 24 months after surgery, assessed using the Engel classification and seizure diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between patients' social profile and incidence of PTSD | 3 months before surgery - Visit 2 (V2) | Proportion of medico-psychosocial data collected before and after surgery (age, sex, family situation, level of education, professional status, history, anamnesis, treatments, side effects and surgical complications) including traumatic exposures and/or PTSD, measured with the following scales: traumatic exposures during childhood (CTQ-SF, score between 5 and 25 in 5 areas with thresholds that vary depending on the area), lists of traumatic exposures (LEC-5, no total score), screening for PTSD according to DSM-V criteria (PCL-5, threshold \> /= 31/80) and PTSD related to epileptic seizures (PTSD-E, score between 0 and 80, high if PTSD) |
| influence of surgery on psychiatric comorbidities | from baseline to 24 months post surgery | Change in psychiatric comorbidities after surgery (anxiety, depressive symptoms, PTSD symptoms), social vulnerability, quality of life, and surgical satisfaction between the preoperative assessment and 24-month follow-up. Outcomes will be assessed using, for anxiety :the Generalized Anxiety Disorder-7 (GAD-7 between 0 and 21, 21 meaning bad outcome), for depression, Neurological Disorders Depression Inventory for Epilepsy (NDDI-E, 6 to 24, 24 meaning bad outcome), and for PTSD, PTSD Checklist for DSM-5 (PCL-5, 0 to 52, 52 being the worst outcome), PTSD for Epilepsy (PTSD-E), EPICES score. |
| Influence of surgery on the quality of life | Change in quality of life after surgery using the Quality of Life in Epilepsy Inventory Form 31 (QOLIE-31, 0 to 100, 100 being the best outcome), and Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19). | from baseline to 24 months post surgery |
| Correlation between surgical success and initial psychological profile | 24 months after surgery (V6) | Correlation between surgical success (Engel Class IA versus non-IA) and participants clinical, psychological, and social characteristics collected before and after surgery. Factors associated with surgical success will be explored using univariate and multivariable analyses. |
Contacts
CONTACTMelissa DENIS
Outcome results
None listed