Epilepsies, FocalPEPSYNCT07718542
Prognosis of Epilepsy With Post-traumatic Stress Disorder and Surgery
An observational study of Epilepsies, Focal and Drug Restistant Epilepsie, run by Assistance Publique Hopitaux De Marseille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsies, Focal, Drug Restistant Epilepsie, Anxiety Disorders
- What is being tested?
- Baseline PTSD status and Psychiatric questionnaires
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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)
- Being tested
- Baseline PTSD status, Psychiatric questionnaires
- Keywords
- Epilepsy surgery, Drug-resistant focal epilepsy, Post-traumatic stress disorder, Surgical outcomes, Advanced practice nursing
- Medical subject headings
- Epilepsies, Partial, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline PTSD statusOther
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).
Psychiatric questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: PTSD-negative (PTSD-) | Participants without a diagnosis of post-traumatic stress disorder. Receives: 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. Receives: Other: Baseline PTSD status; Other: Psychiatric questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months post-surgery
Secondary outcomes (5)
Correlation between patients' social profile and incidence of PTSD
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)
Measured: 3 months before surgery - Visit 2 (V2)
influence of surgery on psychiatric comorbidities
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.
Measured: from baseline to 24 months post surgery
Influence of surgery on the quality of life
from baseline to 24 months post surgery
Measured: 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
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).
Measured: from baseline to 24 months post surgery
Correlation between surgical success and initial psychological profile
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.
Measured: 24 months after surgery (V6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsies, FocalStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718542
- Sponsor's protocol ID
- RCAPHM25_0444
- Other IDs
- ID RCB: 2026-A00196-45
- Acronym
- PEPSY
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Prognosis for Drug-resistant Focal Epilepsy Associated With Post-traumatic Stress Disorder (PTSD): a Multidimensional Assessment of the Success of Resective Surgery.
- ClinicalTrials.gov ID
- NCT07718542
- Acronym / sponsor ID
- PEPSY / RCAPHM25_0444
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: PTSD-negative (PTSD-) | – | Other: Baseline PTSD status, Other: Psychiatric questionnairesParticipants without a diagnosis of post-traumatic stress disorder. |
| Group 2: PTSD-positive (PTSD+) | – | Other: Baseline PTSD status, Other: Psychiatric questionnairesParticipants with a diagnosis of post-traumatic stress disorder confirmed following screening and routine psychiatric assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline PTSD statusThe 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 | Group 1: PTSD-negative (PTSD-), Group 2: PTSD-positive (PTSD+) |
| Psychiatric questionnairesThis 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. | Other | Group 1: PTSD-negative (PTSD-), Group 2: PTSD-positive (PTSD+) |
Primary outcome
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.
5 secondary outcomes
Correlation between patients' social profile and incidence of PTSD
Time frame: 3 months before surgery - Visit 2 (V2)
influence of surgery on psychiatric comorbidities
Time frame: 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).
influence of surgery on psychiatric comorbidities
Time frame: from baseline to 24 months post surgery
Correlation between surgical success and initial psychological profile
Time frame: 24 months after surgery (V6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsies, Focal and Drug Restistant Epilepsie, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa DENIS (0491384990 ext. 33, melissa.denis@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success at 24 months after epilepsy surgery (time frame: 24 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.