Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery

Epilepsy Clinical Trial

— EPICHANGE  

Official title:

Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery, With Long-term Epileptological Objective Results

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035965
• Other study ID #: RC31/23/0411
• Status: Recruiting
• Start date: November 30, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Toulouse
• Contact: HELENE MIRABEL
• Phone: 05 61 77 56 14
• Email: mirabel.h[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Epilepsy is one of the most common chronic neurological diseases. According to data from the World Health Organization (WHO), it affects 0.5 to 1% of the population, or around 70 million people world-wide and around 600,000 in France. There are several more or less severe forms of epilepsy depending on the type of epileptic seizures and the frequency of these seizures. About 30% of epileptic patients respond poorly to well-conducted medical treatment, which makes the number of so-called "drug-resistant" patients estimated at between 100,000 and 150,000 patients.

Epilepsy surgery is possible in some cases of drug-resistant epilepsy and can lead to complete seizure control. Beyond the impact on the control of seizures, surgery can have an impact on the lives of patients at the psychological, emotional and cognitive level, with consequences on their socio-professional but also personal life. Thus the impact on the daily life of patients after epilepsy surgery can vary greatly from one patient to another and the personal feelings of operated patients do not always seem to correspond to the objective elements collected by doctors. 2.3 The investigators want to retrospectively assess the satisfaction and quality of life of patients operated on for more than 2 years based on their epileptological results (frequency of seizures).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patient operated in the context of epilepsy surgery dating back more than 2 years in the epileptology center of the Toulouse University Hospital.

• Patient covered by a social security scheme.

• Patient having given his non-objection to participate in the research.

Exclusion Criteria:

• Minor under the age of 15 at the time of the questionnaires.

• Serious psychiatric pathology unrelated to epilepsy surgery.

• Severe intellectual disability limiting responses to self-questionnaires.

• Language barrier.

• Patients under guardianship and protection of justice.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19)
19 items assessing post-surgery satisfaction.
• Quality of Life in Epilepsy Inventory (QOLIE-31)
31 items to assess different dimensions of quality of life
• Generalized Anxiety Disorder 7 (GAD7)
7 items, rated from 0 to 3, to detect anxiety disorders.
• Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
to screen for depressive disorders
• Evaluation of Changes in Daily Life after Epilepsy Surgery (EVOCQUE)
self-questionnaire developed by the Toulouse epileptology team in 2023 for patients who have undergone epilepsy surgery. It aims to collect the feelings of patients concerning the changes induced by surgery in their daily life according to a 7-point Likert scale.

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the changes felt by patients	Evaluate the changes felt by patients more than 2 years after surgery in the context of drug-resistant epilepsy using a new questionnaire created by the epileptology team of the Toulouse University Hospital. The rating of the responses is distributed between 0 and 100 (0 = very negative change, 50 = no change and 100 = very positive change).	2 years