Surgical Prognosis for Drug-resistant Focal Epilepsy Associated With Post-traumatic Stress Disorder (PTSD): a Multidimensional Assessment of the Success of Resective Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Surgical success at 24 months after epilepsy surgery
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Surgical success at 24 months after epilepsy surgery
时间窗: 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.
次要结局
- 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).)
- Correlation between surgical success and initial psychological profile(24 months after surgery (V6))
