Prognosis of Epilepsy With Post-traumatic Stress Disorder and Surgery

NCT07718542 | Not Yet Recruiting

• 2 other identifiers: RCAPHM25_0444ID RCB: 2026-A00196-45
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Conditions

Epilepsies, Focal; Drug Restistant Epilepsie; Anxiety Disorders; Post-traumatic Stress Disorder (PTSD)

Keywords

Epilepsy surgery; Drug-resistant focal epilepsy; Post-traumatic stress disorder; Surgical outcomes; Advanced practice nursing

Outcome Measures

Primary Outcomes (1)

• Surgical success at 24 months after epilepsy 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.

  24 months post-surgery

Secondary Outcomes (5)

• Correlation between patients' social profile and incidence of PTSD

  3 months before surgery - Visit 2 (V2)

• influence of surgery on psychiatric comorbidities

  from baseline to 24 months post surgery

• 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).

• influence of surgery on psychiatric comorbidities

  from baseline to 24 months post surgery

• Correlation between surgical success and initial psychological profile

  24 months after surgery (V6)

Study Arms (2)

Group 1: PTSD-negative (PTSD-)

Participants without a diagnosis of post-traumatic stress disorder.

Other: Baseline PTSD status; Other: Psychiatric questionnaires

Group 2: PTSD-positive (PTSD+)

Participants with a diagnosis of post-traumatic stress disorder confirmed following screening and routine psychiatric assessment.

Other: Baseline PTSD status; Other: Psychiatric questionnaires

Interventions

Baseline PTSD status OTHER

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).

Group 1: PTSD-negative (PTSD-); Group 2: PTSD-positive (PTSD+)

Psychiatric questionnaires OTHER

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.

Group 1: PTSD-negative (PTSD-); Group 2: PTSD-positive (PTSD+)

Eligibility Criteria

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

Study Population

Adults undergoing evaluation for resective surgery for drug-resistant focal epilepsy at the Epileptology Department of Timone University Hospital (Marseille, France) will be recruited over a 2-year period. Participants will be enrolled approximately 3 months before surgery and followed for 24 months postoperatively. PTSD screening will be performed using validated self-report questionnaires. Participants with a positive screening result will undergo routine psychiatric assessment to confirm the diagnosis. Based on these assessments, participants will be classified into either a PTSD-positive (PTSD+, group 2) or PTSD-negative (PTSD-, group 1) cohort. The study aims to recruit 42 participants, with a target of 21 participants in each cohort

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Epilepsies, Partial; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Melissa DENIS

CONTACT

0491384990; melissa.denis@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): May 1, 2031
• Last Updated: July 22, 2026

Record last verified: 2026-07