Prognosis of Epilepsy With Post-traumatic Stress Disorder and Surgery (PEPSY)

July 17, 2026 updated by: Assistance Publique Hopitaux De Marseille

Surgical Prognosis for Drug-resistant Focal Epilepsy Associated With Post-traumatic Stress Disorder (PTSD): a Multidimensional Assessment of the Success of Resective Surgery.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: PTSD-negative (PTSD-)
Participants without a diagnosis of post-traumatic stress disorder.
Other: Baseline 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).
Other: Psychiatric questionnaires
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 2: PTSD-positive (PTSD+)
Participants with a diagnosis of post-traumatic stress disorder confirmed following screening and routine psychiatric assessment.
Other: Baseline 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).
Other: Psychiatric questionnaires
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical success at 24 months after epilepsy surgery
Time Frame: 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.
24 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between patients' social profile and incidence of PTSD
Time Frame: 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)
3 months before surgery - Visit 2 (V2)
influence of surgery on psychiatric comorbidities
Time Frame: 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.
from baseline to 24 months post surgery
Influence of surgery on the quality of life
Time Frame: 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
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
Time Frame: from baseline to 24 months post surgery
Change in 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: the Generalized Anxiety Disorder-7 (GAD-7 between 0 and 21, 21 meaning bad outcome), Neurological Disorders Depression Inventory for Epilepsy (NDDI-E, 6 to 24, 24 meaning bad outcome), PTSD Checklist for DSM-5 (PCL-5, 0 to 52, 52 being the worst outcome), PTSD for Epilepsy (PTSD-E), EPICES score, 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
Time Frame: 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.
24 months after surgery (V6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

July 17, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCAPHM25_0444
  • ID RCB: 2026-A00196-45 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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