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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Other: Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19); Other: Quality of Life in Epilepsy Inventory (QOLIE-31); Other: Generalized Anxiety Disorder 7 (GAD7); Other: Neurological Disorders Depression Inventory for Epilepsy (NDDI-E); Other: Evaluation of Changes in Daily Life after Epilepsy Surgery (EVOCQUE)

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: HELENE MIRABEL; Phone Number: +33 05 61 77 56 14; Email: mirabel.h@chu-toulouse.fr
• Study Contact Backup: Name: AMAURY DE BARROS; Phone Number: +33 05 61 77 90 27; Email: debarros.a@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • CHU de Toulouse
    • Contact: HELENE MIRABEL; Email: MIRABEL.H@CHU-TOULOUSE.FR
    • Contact: AMAURY DE BARROS; Email: debarros.a@chu-toulouse.fr
    • Principal Investigator: HELENE MIRABEL
    • Sub-Investigator: AMAURY DE BARROS
    • Sub-Investigator: MARIE DENUELLE
    • Sub-Investigator: LUC VALTON
    • Sub-Investigator: JONATHAN CUROT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: HELENE MIRABEL, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: RC31/23/0411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No